{"extracted_on":"2026-04-18 12:30:11 CET","deviceList":[{"id_device":"1","commercial_name":"1copy COVID-19 qPCR Kit","manufacturer":{"id_manufacturer":"1","name":"1drop Inc.","country":"South Korea","website":"www.1drop.co.kr\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"Based on KCDC method  ","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" https:\/\/www.jenabioscience.com\/\/files\/jenabioscience\/datasheet_extern\/PCR-703.pdf","performances":[{"parameter":"LOD","value":"200","unit":"copies\/ml"},{"parameter":"Positive control","info":"E 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protein","spike protein"],"notes":"The 1copy\u2122 COVID-19 MDx Kit Professional is an In vitro diagnostic medical device intended to diagnose COVID-19 infection by detecting S gene and N gene of SARS-CoV-2 via loop-mediated isothermal amplification (LAMP) in upper respiratory specimens, nasopharyngeal swabs, collected from patients suspected of COVID-19. 1POT\u2122 Professional device, used with 1copy\u2122 COVID-19 MDx Kit Professional, is an in-vitro diagnostic system intended for the qualitative detection of nucleic acids via loop-mediated isothermal amplification (LAMP) from SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of COVID-19.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2626","assay_category":"Nucleic 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Testing is limited to laboratories - certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. \u00a7263a, to perform high complexity tests or similarly qualified non-U.S. laboratories. Results are used to identify the presence of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate presence of SARS-CoV-2 RNA, but clinical correlation with patient history and other diagnostic information are necessary to rule out a patient's infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. 1copy\u2122 COVID-19 qPCR 4plex Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2625","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":"No","reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"50","performances":[{"parameter":"LOD","value":"400","unit":"cpm"},{"parameter":"Positive control","info":"N gene plasmid, E gene plasmid and RdRp gene plasmid"},{"parameter":"Negative control","info":"DEPC DW"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"10"},{"parameter":"Throughput","info":"96 samples per run"}]}]},{"id_device":"2917","commercial_name":"1copy\u2122 COVID-19 qPCR Multi Kit","manufacturer":{"id_manufacturer":"1","name":"1drop Inc.","country":"South Korea","website":"www.1drop.co.kr\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":["Anterior nasal swab","Mid-turbinates swab","Nasal aspirate","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["envelope protein","ORF1ab polyprotein"],"notes":"1copy\u2122 COVID-19 qPCR Multi Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, mid-turbinate nasal swab specimens as well as nasopharyngeal wash\/aspirate and nasal aspirate specimens collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories - certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. \u00a7263a, to perform high complexity tests or by similarly qualified non-U.S. laboratories. Results are used to identify the presence of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during an acute phase of infection. Positive results indicate presence of SARS-CoV-2 RNA, but clinical correlation with patient history and other diagnostic information are necessary to rule out a patient's infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. 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Testing is limited to laboratories - certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. \u00a7263a, to perform high complexity tests or similarly qualified non-U.S. laboratories. Results are used to identify the presence of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate presence of SARS-CoV-2 RNA, but clinical correlation with patient history and other diagnostic information are necessary to rule out a patient's infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. 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Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. \u00a7263a, to perform high complexity tests. Results are for the identification of SARS-CoV-2, Influenza A, Influenza B and RSV RNA. RNA from SARS-CoV-2 and\/or Influenza A, Influenza B and RSV viruses is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other viruses; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B and RSV infection and should not be used as the sole basis for diagnosis, treatment for other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results obtained from individuals who are not exhibiting clinical signs and symptoms associated with respiratory viral infection at the time of specimen collections should be interpreted with particular caution. Negative results in asymptomatic individuals cannot be used as definitive evidence that an individual has not been exposed to SARS-CoV-2 or influenza viruses and has not been infected with any of these viruses. 1copy\u2122 COVID-19\/FluA\/FluB\/RSV qPCR Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2624","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":"No","reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"50","performances":[{"parameter":"LOD","value":"800","unit":"cpm"},{"parameter":"Positive control","info":"N gene plasmid, RdRp gene plasmid, Flu A gene plasmid, Flu B gene plasmid and RSV gene plasmid"},{"parameter":"Negative control","info":"DEPC DW"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","info":"96 samples per run"}]}]},{"id_device":"3","commercial_name":"TRUPCR SARS-CoV-2 RT qPCR Kit","manufacturer":{"id_manufacturer":"3","name":"3B BlackBio Biotech India Ltd.","country":"India","website":"www.3bblackbio.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"E, RdRP and N gene targets  ","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"4","assay_category":"Nucleic acid-PCR","rapid_diagnostic":"No","self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"https:\/\/3bblackbio.com\/covid-19-corona-virus-real-time-qpcr-kit-sars-cov-2-trupcr.html","performances":[]}]},{"id_device":"2254","commercial_name":"96A Viral RNA Auto Extraction & Purification Kit","manufacturer":{"id_manufacturer":"1050","name":"3D Biomedicine Science & Technology Co. 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The product is intended to be used by professional users that are trained in molecular biological techniques.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1955","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":null,"measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2252","commercial_name":"ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit","manufacturer":{"id_manufacturer":"1050","name":"3D Biomedicine Science & Technology Co. 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","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2","assay_category":"Nucleic acid-PCR","rapid_diagnostic":"No","self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" http:\/\/www.3dmedcare.com\/UploadImage\/covid\/01%20IFU%20for%203DMed%202019-nCoV%20RT-qPCR%20Detection%20Kit.pdf","performances":[{"parameter":"LOD","value":"5","unit":"RNA-copies\/test"},{"parameter":"Positive control","info":"ORF1ab, N and E gene. 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COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood\/ Serum\/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. 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COVID-19 and M.pneumoniae IgG\/IgM Combo Rapid Test (Whole Blood\/Serum\/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG\/IgM Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARSCoV-2\/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended for use by trained laboratory personnel. The test provides preliminary test results. Negative results will not preclude SARS-COV2\/ M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. 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COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. 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Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1625","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.007","unit":"AU"},{"parameter":"False negatives","value":"0.097","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.3","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1700","commercial_name":"COVID-19 Antigen Test Cassette (For Analyzer)","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1380","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6.7","unit":"AU"},{"parameter":"False negatives","value":"1.6","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.2","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.3","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"1695","commercial_name":"COVID-19 IgG Rapid Test","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1374","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.7","unit":"AU"},{"parameter":"False 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blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The COVID-19 IgG Rapid Test (Whole Blood\/Serum\/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human whole blood, serum or plasma specimen. The COVID-19 IgG Rapid Test (Whole Blood\/Serum\/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2130","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","info":"100"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.071","unit":"AU","info":"(SARS-CoV-2);"},{"parameter":"False positives","value":"0.015","unit":"AU","info":"(vaccination)"},{"parameter":"False negatives","value":"0","unit":"AU","info":"(SARS-CoV-2);"},{"parameter":"False negatives","value":"0.001","unit":"AU","info":">0.001(vaccination)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.4","unit":"% IgG","info":"(SARS-CoV-2);"},{"parameter":"Accuracy","value":"98.9","unit":"% IgG","info":"(vaccination)."},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.9","unit":"% IgG","info":"(SARS-CoV-2);"},{"parameter":"Clinical Sensitivity","value":"98.5","unit":"% IgG","info":"(vaccination)."},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG","info":"(SARS-CoV-2);"},{"parameter":"Clinical Specificity","value":"99.9","unit":"% IgG","info":"(vaccination)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1677","commercial_name":"COVID-19 IgG\/IgM Rapid Test (For Reader)","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1356","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5.6","unit":"AU"},{"parameter":"False negatives","value":"5","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94.9","unit":"%","info":" (IgG\/IgM)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.4","unit":"%"}]}]},{"id_device":"2433","commercial_name":"COVID-19 IgG\/IgM Rapid Test (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The COVID-19 IgG\/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen from patients suspected of COVID-19 infection by a healthcare provider. The COVID-19 IgG\/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG\/IgM Rapid Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG\/IgM Rapid Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2136","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.056","unit":"AU"},{"parameter":"False negatives","value":"0.05","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94.9","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.4","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Clinical Specificity","value":"95","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"465","commercial_name":"COVID-19 IgG\/IgM Rapid Test Cassette","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"712","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"False positives","info":"Evaluated"},{"parameter":"False negatives","info":"Evaluated"},{"parameter":"Accuracy","value":"98.6","unit":"% IgG"},{"parameter":"Accuracy","value":"92.9","unit":"% IgM"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"85","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"98","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"96","unit":"% IgM"}]}]},{"id_device":"1694","commercial_name":"COVID-19 IgG\/IgM Rapid Test Dipstick","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1373","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU","info":"(IgG)"},{"parameter":"False positives","value":"3","unit":"AU","info":"(IgM)"},{"parameter":"False negatives","value":"0.1","unit":"AU","info":"(IgG)"},{"parameter":"False negatives","value":"9.1","unit":"AU","info":"(IgM)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"% IgG"},{"parameter":"Accuracy","value":"95.9","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.9","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"90.9","unit":"% IgM"}]}]},{"id_device":"1676","commercial_name":"COVID-19 IgG\/IgM Test Cassette (for Analyzer)","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1355","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.1","unit":"AU"},{"parameter":"False negatives","value":"3.3","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.9","unit":"%","info":"(IgG, IgM)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.7","unit":"%","info":"(IgG\/IgM)"}]}]},{"id_device":"2267","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Nasal Swab)","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The ACRO SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a lateral flow immunoassay for the qualitative detection of Nucleocapsid protein antigens of SARS-CoV-2 in swab specimens from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 antigen is able to be detected in the upper respiratory tract during the acute phase of infection. The ACRO SARS-CoV-2 Antigen Rapid Test (Nasal Swab) tests for the SARS-CoV-2 nucleocapsid protein antigen in upper respiratory specimens. While a positive result indicates the existence of the viral antigen, further evaluation of patient history and diagnostics are necessary to confirm these results. A patient may experience concurrent infection with other viruses or a bacterial infection which are not ruled out by a positive SARS-CoV-2 antigen result. Detection of the antigen does not surely certify it as the cause of the disease. Negative results should be treated as presumptive and confirmation with a molecular assay may be necessary for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2023-05-17 17:26:51 CET","testList":[{"id_test":"21057","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.054","unit":"AU"},{"parameter":"False negatives","value":"0.006","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.6","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleoproteins"}]}]},{"id_device":"1948","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Swab)","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"The ACROTM SARS-CoV-2 Antigen Rapid Test (Swab) is a lateral flow immunoassay for the qualitative detection of Nucleocapsid protein antigens of SARS-CoV-2 in swab specimens from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 antigen is able to be detected in the upper respiratory tract during the acute phase of infection. The ACROTM SARS-CoV-2 Antigen Rapid Test (Swab) tests for the SARS-CoV-2 nucleocapsid protein antigen in upper respiratory specimens. While a positive result indicates the existence of the viral antigen, further evaluation of patient history and diagnostics are necessary to confirm these results. A patient may experience concurrent infection with other viruses or a bacterial infection which are not ruled out by a positive SARS-CoV-2 antigen result. Detection of the antigen does not surely certify it as the cause of the disease. Negative results should be treated as presumptive and confirmation with a molecular assay may be necessary for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1624","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.006","unit":"AU"},{"parameter":"False negatives","value":"0.063","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.7","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.7","unit":"%"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapside"}]}]},{"id_device":"1693","commercial_name":"SARS-COV-2 RT-qPCR Assay","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1372","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"100","notes":" https:\/\/www.acrobiotech.com\/covid-19-tests","performances":[{"parameter":"LOD","value":"200","unit":"AU"},{"parameter":"Positive control","info":"RAN Pseudovirus"},{"parameter":"Negative control","info":"DEPC-Treated Water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"99.14","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"99.14","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"2397","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus(RSV) antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2\/Influenza\/RSV infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B and RSV Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/Influenza A+B\/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, Influenza A+B and RSV. The SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2099","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.023","unit":"AU","info":"(SARS-CoV-2 Test);"},{"parameter":"False positives","value":"0.051","unit":"AU","info":"(RSV Test)."},{"parameter":"False positives","value":"0.054","unit":"AU","info":"(Influenza Type B);"},{"parameter":"False positives","value":"0.03","unit":"AU","info":"(Influenza Type A);"},{"parameter":"False 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SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV) and Adenovirus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2\/ Influenza\/ RSV\/Adenovirus infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV and Adenovirus antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B\/RSV\/Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, Influenza A+B ,RSV and Adenovirus. The SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2111","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.032","unit":"AU","info":"(Adenovirus)"},{"parameter":"False positives","value":"0.023","unit":"AU","info":"(SARS-CoV-2),"},{"parameter":"False positives","value":"0.051","unit":"AU","info":"(RSV),"},{"parameter":"False positives","value":"0.054","unit":"AU","info":"(Influenza Type B),"},{"parameter":"False 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Specificity","value":"98.4","info":"Antigen)(RSV);"},{"parameter":"Clinical Specificity","value":"98.5","info":"(Antigen)(Adenovirus)."},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2411","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"890","name":"Acro Biotech Inc.","country":"United States","website":"www.acrobiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal 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SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV), Adenovirus and M.pneumoniae antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2\/Influenza\/RSV\/Adenovirus\/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV, Adenovirus and M.pneumoniae antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of correlative antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, Influenza A+B,RSV, Adenovirus and M.pneumoniae. The SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2113","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.071","unit":"AU","info":"(M.pneumoniae)"},{"parameter":"False positives","value":"0.023","unit":"AU","info":"(SARS-CoV-2)"},{"parameter":"False positives","value":"0.032","unit":"AU","info":"Adenovirus)"},{"parameter":"False positives","value":"0.051","unit":"AU","info":"(RSV)"},{"parameter":"False 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CET","testList":[{"id_test":"872","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Quantitative","subclass":null,"detection_principle":"Magnetic Electrochemical","subcategory":null,"time_minutes":null,"performances":[{"parameter":"Clinical Sensitivity","value":"95.2","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"}]}]},{"id_device":"1093","commercial_name":"AESKULISA SARS-CoV-2 NP 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Test principle: The AESKU.RAPID SARS-CoV-2 rapid test is based on immunochromatographic polymer technology combined with the sandwich principle for the qualitative detection of the nucleocapsid protein antigen in human nasal swab samples. The sample is mixed with colored polymer-labeled SARS-CoV-2 monoclonal antibody 1 in the test device's sample well and chromatographed along the nitrocellulose membrane. If SARS-CoV-2 antigens are present in the sample, they will bind to SARS-CoV-2 antibody 1, and the mixture will bind to immobilized SARS-CoV-2 antibody 2 on the nitrocellulose membrane. The resulting complex of antibody 1, antigen, and antibody 2 forms the colored test line. The test device's control line is coated with secondary antibodies, resulting in a colored result during a standard test procedure.","last_updated":"2022-10-17 12:52:06 CET","testList":[{"id_test":"5203","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.8","unit":"%","info":"4 false positives out of 222 negative samples"},{"parameter":"False negatives","value":"3.66","unit":"%","info":"4 false negatives out of 109 positive samples"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"0","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2136","commercial_name":"InfectCheck\u00ae - COVID-19 IgG\/IgM Test","manufacturer":{"id_manufacturer":"987","name":"Affimedix Inc.","country":"United States","website":"www.affimedix.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"Digital result reading with a Reader","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1826","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.3","unit":"%"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2137","commercial_name":"InfectCheck\u00ae COVID-19 NAb Test","manufacturer":{"id_manufacturer":"987","name":"Affimedix Inc.","country":"United States","website":"www.affimedix.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"InfectCheck\u00ae COVID-19 NAb Test is an in vitro Rapid \u201cSandwich\u201d immunochromatography test for the \u201cQuantitative\u201d detection of circulating functional Neutralizing Antibodies (NAb) Titer post COVID-19 Vaccination or after SARS-CoV-2 Infection using a Reader. InfectCheck\u00ae COVID-19 NAb Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. InfectCheck\u00ae COVID-19 NAb Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https:\/\/www.jimmunol.org\/content\/206\/10\/2393) InfectCheck\u00ae COVID-19 NAb Test has been standardized against \u201cFirst WHO International Standard for anti-SARS-CoV-2 Immunoglobulins\u201d (NIBSC Code: 20\/136) with excellent Correlation Coefficient (R2 = 0.99). Limit of Detection (LOD): 25 \u2013 50 BAU\/ml (Test Lot dependent).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1827","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"NAb test","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.17","unit":"%"},{"parameter":"Clinical Specificity","value":"98.67","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2130","commercial_name":"TestNOW\u00ae - COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"987","name":"Affimedix Inc.","country":"United States","website":"www.affimedix.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"Digital Result option available with a Reader.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1820","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"126","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.6","unit":"%"},{"parameter":"False negatives","value":"3.9","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.1","unit":"%","info":"Anterior Nasal Swab"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Nasopharyngeal Swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Anterior Nasal Swab"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"Nasopharyngeal Swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2132","commercial_name":"TestNOW\u00ae - 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COVID-19 NAb Quantitative Test","manufacturer":{"id_manufacturer":"987","name":"Affimedix Inc.","country":"United States","website":"www.affimedix.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"TestNOW\u00ae - COVID-19 NAb Quantitative Test is an in vitro Rapid \u201cSandwich\u201d immunochromatography test for the \u201cQuantitative\u201d detection of circulating functional Neutralizing Antibodies (NAb) Titer post COVID-19 Vaccination or after SARS-CoV-2 Infection using a Reader. TestNOW\u00ae - COVID-19 NAb Quantitative Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. TestNOW\u00ae - COVID-19 NAb Quantitative Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https:\/\/www.jimmunol.org\/content\/206\/10\/2393) TestNOW\u00ae - COVID-19 NAb Quantitative Test has been standardized against \u201cFirst WHO International Standard for anti-SARS-CoV-2 Immunoglobulins\u201d (NIBSC Code: 20\/136) with excellent Correlation Coefficient (R2 = 0.99). Limit of Detection (LOD): 25 \u2013 50 BAU\/ml (Test Lot dependent).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1824","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","unit":"AU","info":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.17","unit":"%"},{"parameter":"Clinical Specificity","value":"98.67","unit":"%"}]}]},{"id_device":"1396","commercial_name":"MassARRAY SARS-CoV-2 Panel","manufacturer":{"id_manufacturer":"662","name":"AgenaBioscience Inc.","country":"United States","website":"agenabio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":" reverse transcription (RT-PCR)\/MALDI-TOF test; positive control: Twist Bioscience Synthetic SARS-CoV-2 RNA Control 1 #102019; extraction control: MS2 Phage RNA  https:\/\/agenabio.com\/products\/panel\/coronavirus-sars-cov-2-detection-panel\/","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1162","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"82","notes":" https:\/\/agenabio.com\/wp-content\/uploads\/2020\/11\/MA_SC2_Panel_EUA_IFU-CUS-001_R06.pdf","performances":[{"parameter":"LOD","value":"2.5","unit":"copies\/\u03bcl"},{"parameter":"Positive control","info":"Synthetic SARS-CoV-2 RNA Control "},{"parameter":"Negative control","info":"Nuclease-free water"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"994","commercial_name":"Acro 2019-nCoV IgG\/IgM pikatesti","manufacturer":{"id_manufacturer":"594","name":"AIDIAN","country":"Finland","website":"www.aidian.eu\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"902","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[]}]},{"id_device":"3036","commercial_name":"Novel Coronavirus (2019-nCoV) Antigen Detection Kit (AIE Fluorescence Immunochromatography)","manufacturer":{"id_manufacturer":"1351","name":"AIETech Co. Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":["Coronaviruses (HCoV)"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"frist application","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2742","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"140","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.48","unit":"AU"},{"parameter":"False negatives","value":"10.68","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.15","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"89.32","unit":"%"},{"parameter":"Clinical Specificity","value":"99.52","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3022","commercial_name":"COVID-19 Antigen Rapid Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"1341","name":"Aikang Diagnostics Co. 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Ltd.","country":"China","website":"www.anbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["Coronaviruses (HCoV)"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"Certified CE1434 by Notified Body of POLISH CENTRE FOR TESTING AND CERTIFICATION (POLSKIE CENTRUM BADAN I CERTYFIKACJI)","last_updated":"2022-08-24 15:42:41 CET","testList":[{"id_test":"3708","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"150","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"98.33","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"1.67","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.52","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.06","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1822","commercial_name":"Rapid COVID-19 Antigen Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"307","name":"Anbio (Xiamen) Biotechnology Co. Ltd.","country":"China","website":"www.anbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Throat swab"],"pathogen":["Coronaviruses (HCoV)"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1732","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"150","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.5","unit":"%","info":"Nasopharyngeal Swab"},{"parameter":"Accuracy","value":"99.3","unit":"%","info":"Nasal Swab"},{"parameter":"Accuracy","value":"99.2","unit":"%","info":"Throat Swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.33","unit":"%","info":"Nasopharyngeal Swab"},{"parameter":"Clinical Sensitivity","value":"97.33","unit":"%","info":"Nasal Swab"},{"parameter":"Clinical Sensitivity","value":"97.67","unit":"%","info":"Throat Swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Nasopharyngeal Swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Nasal Swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Throat Swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2239","commercial_name":"Rapid COVID-19 Antigen Test\uff08Colloidal Gold\uff09","manufacturer":{"id_manufacturer":"1040","name":"Anbio (Xiamen) Biotechnology Co. Ltd.","country":"China","website":"www.anbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Saliva","Throat swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Approved by Germany Approved by Paul-Ehrlich-Institut\uff0clist on BfArm self test list\uff0cthe number is 5640-S-058\uff08saliva\uff09and 5640-S-310\uff08Nasal Swab\uff09.According to the evaluation report of PacGenomics Clinical Genetics Laboratory in the United States, the sensitivity and specificity of Anbio's Rapid COVID-19 Antigen test kit \uff08Colloidal Gold\uff09 are 98.51% and 99.63%.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1940","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"150","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False 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(HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Anti-Nuclear Antibody","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Bordetella Pertussis","Chlamydia Pneumoniae","Coronaviruses (HCoV)","Cytomegalovirus (CMV)","Enterovirus A71 (EV-A71)","Epstein-Barr Virus (EBV)","Hemophilus Influenzae","Hepatitis A Virus (HAV)","Hepatitis B Virus (HBV)","Hepatitis C Virus (HCV)","Herpes Simplex (HSV)","Human Immunodeficiency Virus (HIV)","Human Metapneumovirus (HMPV)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza A H5N1","Influenza B","Influenza B Victoria","Influenza B Yamagata","MERS-CoV","Mumps Virus (MuV)","Mycobacterium Tuberculosis","Mycoplasma Pneumoniae","Other","Parainfluenza Virus Type","Parainfluenza Virus Type 1","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Respiratory Syncytial V (RSV)","Respiratory Syncytial V (RSV) Type A","Respiratory Syncytial V (RSV) Type B","Rhinovirus","Rhinovirus A","Rhinovirus B","SARS-CoV","SARS-CoV-2","Varicella Zoster Virus (VZV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["non-structural protein NS10","non-structural protein NS3a"],"last_updated":"2022-10-18 15:13:13 CET","testList":[{"id_test":"5212","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Chromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"175","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"96.03","unit":"%"},{"parameter":"Analytical Specificity","value":"98.83","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.3","unit":"%"},{"parameter":"False negatives","value":"3.4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.5","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.03","unit":"%"},{"parameter":"Clinical Specificity","value":"98.83","unit":"%"}]}]},{"id_device":"34","commercial_name":"Colloidal gold strip for SARS-CoV-2 IgG & IgM","manufacturer":{"id_manufacturer":"24","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"28","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":null,"notes":"Rapid diagnostic test   ","performances":[]}]},{"id_device":"1736","commercial_name":"COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"24","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"1. Passed the UK Department of Health and Social Care (DHSC) Phase 3B validation. - Only 4 to 5 manufacturers all over the world have passed Phase 3B. 2. Germany PEI Eveluation. 3. Delta and Omicron variants clinical validation in EU countries.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1415","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","notes":"Other pathogens tested for cross-reactivity: Streptococcus pneumoniae, Streptococcus pyogenes, Candida albicans, Pneumocystis jirovecii, Legionella pneumophila, Pseudomonas Aeruginosa, Staphylococcus Epidermidis, Streptococcus Salivarius","performances":[{"parameter":"LOD","value":"80","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.2","unit":"%"},{"parameter":"False negatives","value":"3.6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.03","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1589","commercial_name":"COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold) - (Nasal swab\/saliva)","manufacturer":{"id_manufacturer":"24","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Saliva"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":" website not accessible (considered suspicious for the EC) ","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1269","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"20","notes":"Rapid diagnostic test cassette  ","performances":[{"parameter":"LOD","value":"320","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0"},{"parameter":"False negatives","value":"3.6"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.03","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"1815","commercial_name":"COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) - Nasal Swab","manufacturer":{"id_manufacturer":"24","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https:\/\/www.medrxiv.org\/content\/10.1101\/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https:\/\/www.medrxiv.org\/content\/10.1101\/2021.01.13.21249563v1.full-text And we have attached the MHRA registration certificate. Also the registration in Germany, registration in Italy, registration in Portugal and so on.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1493","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"320","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.2","unit":"%"},{"parameter":"False negatives","value":"3.6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.03","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2750","commercial_name":"COVID-19 (SARS-CoV-2) Antigen Test Kit (self-testing)","manufacturer":{"id_manufacturer":"24","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"We obtained CE1434 self-test certificate and the registration in Germany, registration in Italy, registration in Portugal and so on.Also we have attached the MHRA registration certificate. Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https:\/\/www.medrxiv.org\/content\/10.1101\/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https:\/\/www.medrxiv.org\/content\/10.1101\/2021.01.13.21249563v1.full-text","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2455","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"80","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.2","unit":"%"},{"parameter":"False negatives","value":"3.6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.03","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2651","commercial_name":"COVID-19 (SARS-CoV-2) Antigen Test Midstream \u2014 Saliva","manufacturer":{"id_manufacturer":"1020","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"This product is used for in vitro qualitative detection of the antigen of SARS-CoV-2 in human saliva specimen. It finished registration in Germany and also in German BfArM List.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2356","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"80","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.05","unit":"%"},{"parameter":"False negatives","value":"2.5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.5","unit":"%"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"510","commercial_name":"COVID-19 (SARS-CoV-2) IgG\/IgM Antibody Test Kit","manufacturer":{"id_manufacturer":"24","name":"Anhui Deep Blue Medical Technology Co. 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Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"This product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody in human serum, plasma, whole blood and\/or fingertip blood. This product uses double antigen sandwich method for detection. The gold label pad is marked with S-RBD-mFc C-terminal, and the detection line is coated with S-RBD-mFc N-terminal. When the sample contains neutralizing antibody, it will bind to S-RBD-mFc C-terminal, then the complex will be captured by pre-coated S-RBD-mFc N-terminal and the T line will show color. When the sample does not contain neutralizing antibodies, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1890","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"20","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False negatives","value":"7","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2198","commercial_name":"COVID-19 (SARS-CoV-2) Neutralizing Antibody IgG Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"1020","name":"Anhui Deep Blue Medical Technology Co. 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This product uses capture method for detection. The gold label pad is marked with S-RBD protein, and the detection line is coated with mouse-anti-human IgG. When the sample contains neutralizing antibody IgG, it will bind to the S-RBD protein, then the complex will be captured by pre-coated mouse anti-human IgG and the T line will show color. When the sample does not contain neutralizing antibodies IgG, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody IgG.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1899","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.2","unit":"%"},{"parameter":"False negatives","value":"7.8","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.2","unit":"%"},{"parameter":"Clinical Specificity","value":"95.7","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2089","commercial_name":"New Coronavirus (COVID-19) Antigen Rapid Test","manufacturer":{"id_manufacturer":"967","name":"Anhui Formaster Biosci Co. 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recommended.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2077","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.016","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.4","unit":"%"},{"parameter":"False negatives","value":"2.2","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.01","unit":"%"},{"parameter":"Clinical Specificity","value":"97.9","unit":"%"},{"parameter":"Type of 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Please update the link of the scientific publication in the online database to https:\/\/www.nature.com\/articles\/s41598-021-99886-6 since the article has now been peer reviewed and published.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1760","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"120","notes":"https:\/\/www.nature.com\/articles\/s41598-021-99886-6 ","performances":[{"parameter":"LOD","value":"2.7","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"No false positives"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"768","commercial_name":"mariPOC SARS-CoV-2","manufacturer":{"id_manufacturer":"454","name":"ArcDia International Ltd.","country":"Finland","website":"www.arcdia.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Automated","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Other"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"No crossreactivity with MERS, seasonal coronaviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial flora. The test is designed to escape SARS-CoV strain variations. It detects so conserved epitope that it is shared also by SARS-CoV(-1) from year 2003.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"622","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","notes":"https:\/\/www.nature.com\/articles\/s41598-021-99886-6","performances":[{"parameter":"LOD","value":"2.7","unit":"AU"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"no"},{"parameter":"False negatives","value":"0","unit":"%","info":"no"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3568","commercial_name":"CoVard Covid-19 Nasal Antigen Test Kit","manufacturer":{"id_manufacturer":"1424","name":"ARD\u0130 MED\u0130KAL ARA\u015eTIRMA VE D\u0130AGNOST\u0130K \u00dcR\u00dcNLER\u0130 SAN. T\u0130C. LTD. \u015eT\u0130.","country":"Turkey","website":"www.ardimed.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3286","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"4000","commercial_name":"CoVard Covid-19 Rapid Antigen Test Kit","manufacturer":{"id_manufacturer":"1424","name":"ARD\u0130 MED\u0130KAL ARA\u015eTIRMA VE D\u0130AGNOST\u0130K \u00dcR\u00dcNLER\u0130 SAN. T\u0130C. LTD. \u015eT\u0130.","country":"Turkey","website":"www.ardimed.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3665","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"2633","commercial_name":"Anti-SARS-CoV-2-Multi-Antik\u00f6rper IgG\/Nab-Test (IgG-Antik\u00f6rper\/neutralisierende Antik\u00f6rper) (LFIA)","manufacturer":{"id_manufacturer":"1011","name":"Aripa Biotec GmbH","country":"Germany","website":"www.aripa-biotec.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum","Venous whole blood","Whole 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anti-SARS-CoV-2 multi-antibody IgG\/Nab Tests (IgG antibody\/neutralising antibody) is suitable for the qualitative in vitro detection of SARS-CoV-2 neutralising antibodies and nucleocapsid protein IgG antibodies in human serum, plasma or whole blood. for vaccinated persons and recovered persons.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2338","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.34","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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protein"],"notes":"Positive coincidence rate(Ct value < 25)\uff08Sensitivity\uff09\uff1a99.33%(95% CI: 94.55%~99.82%) Negative coincidence rate\uff08Specificity\uff09\uff1a99.20%(95%CI: 96.32%~99.87%) Total coincidence rate: 99.25% (95%CI: 97.15%~99.78%)","last_updated":"2022-11-23 08:41:09 CET","testList":[{"id_test":"5337","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"28.75","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"AU"},{"parameter":"False 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The results show that ARISTA\u2122 COVID-19 Antigen Rapid Test remain fully capable in detecting the N-protein of the Omicron variant as well as the wildtype SARS-CoV-2 and the Delta Variant with similar sensitivity (LoD: 100 pg\/ml).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1602","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False 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the human RNase P gene"},{"parameter":"Negative control","info":"Nuclease-free water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"5779","commercial_name":"Artron COVID-19 Antigen Self Test","manufacturer":{"id_manufacturer":"721","name":"Artron Laboratories Inc.","country":"Canada","website":"http:\/\/www.artronlab.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other"],"target_type":["Antigen"],"specimen":["Nasal 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This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms of SARS-CoV-2 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1298","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Rapid diagnostic test cassette  ","performances":[{"parameter":"LOD","value":"1000","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.67","unit":"%","info":"Nasal"},{"parameter":"Accuracy","value":"98.25","unit":"%","info":"Nasopharyngeal"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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Performance of the test is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2643","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Compared with PCR test, 154 individuals, 0 false positive"},{"parameter":"False negatives","value":"2.63","unit":"%","info":"Compared with PCR test, 76 individuals, 2 false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2956","commercial_name":"NOVA Test\u00ae SARS-CoV-2 Antigen Home Test Kit","manufacturer":{"id_manufacturer":"924","name":"Atlas Link Technology Co. 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This kit uses a nasal swab sample to reduce discomfort which can be applied to any person ranging from age 18 to 70. Adolescents or children can be tested under adult supervision or tested by an adult. For infants, very young children, or adults older than 70 please consult with your physician before use.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2830","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Compared with PCR test, 419 individuals, 0 false positive"},{"parameter":"False negatives","value":"0.81","unit":"%","info":"Compared with PCR test, 123 individuals, 1 false negative"},{"parameter":"Accuracy","value":"99.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"99.2"},{"parameter":"Clinical Specificity","value":"100"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2010","commercial_name":"NOVA Test\u00ae SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)","manufacturer":{"id_manufacturer":"924","name":"Atlas Link Technology Co. 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Performance of the test is limited to professional use.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1688","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Compared with PCR test, 419 individuals, 0 false positives"},{"parameter":"False negatives","value":"0.81","unit":"%","info":"Compared with PCR test, 123 individuals, 1 false negative"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"99.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"99.2","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2959","commercial_name":"Atlas COVID-19 Antigen (Nasal Swab) Test Cassette","manufacturer":{"id_manufacturer":"1306","name":"Atlas Medical GmbH","country":"Germany","website":"www.atlas-medical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""}],"target":["nucleocapsid protein","spike protein"],"notes":"1) Intended use: Atlas COVID-19 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19. This test is designed for nasal swab samples in symptomatic individuals who are suspected of COVID-19. The COVID-19 Antigen Rapid Test (Nasal Swab) gives a preliminary result only. The final confirmation should be based on clinical diagnostic results. 2) Test Principle: The Atlas Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Nucleocapsid protein Antigens in swab specimens. SARS-CoV-2 Nucleocapsid protein antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 Nucleocapsid protein antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 Nucleocapsid protein antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred. 2) Performance and Specification: Atlas Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with \\collected nasal swab specimen. The test is intended for use in symptomatic individuals meeting the case definition for COVID-19, and to test asymptomatic individuals limited to contacts of confirmed COVID-19 cases or probable cases and to at-risk health workers. Results are for the detection of COVID-19 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARSCoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. 3) Materials provided: \u2022 Atlas COVID-19 Antigen Rapid Test Cassette. \u2022 Sterilized swab. \u2022 Extraction tube. \u2022 Sample extraction buffer. \u2022 Instructions for use","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2665","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml","info":"The LoD for Atlas COVID-19 Rapid Antigen Test (Nasal Swab) is 100 TCID50\/ml of heat-inactivated virus, and 100pg\/ml using a recombinant viral antigen."},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross 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Attana AVA SARS-CoV-2 IgG Immunoassay for use with the Attana Cell 250 or Cell 200 systems to measure SARS-CoV-2 IgG in patient serum samples. CE-IVD registered. Ability to measure affinity of antibody interactions to RBD target","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2036","assay_category":"Immuno-Antibody","rapid_diagnostic":"No","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Quantitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"17","performances":[{"parameter":"LOD","value":"1"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"% 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Ltd.","country":"China","website":"www.hotgen.com.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"437","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"521","commercial_name":"Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology)","manufacturer":{"id_manufacturer":"328","name":"Beijing Hotgen Biotech Co. 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Ltd.","country":"China","website":"www.hotgen.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Peripheral blood","Serum","Venous whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":[],"notes":"There are acolorimetric cards in the product, and the user can judge the semi-quantitative result based on the colorimetric card.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2513","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.25","unit":"AU","info":"The cut off Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies in serum samples detected by this kit was determined to be 0.250(O"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.69","unit":"%","info":"869 samples have 6 false positives"},{"parameter":"False negatives","value":"1.47","unit":"%","info":"339 samples have 5 false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.09","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.53","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.31","unit":"% IgG"}]}]},{"id_device":"2841","commercial_name":"Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"1069","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":"www.hotgen.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab","Throat swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""}],"target":[],"notes":"The product can detect different types of sample.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2546","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"396.22","unit":"TCID50\/ml","info":"2.5\u00d710^2.2 TCID50\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.11","unit":"%","info":"269 positive samples, 3 were false negative."},{"parameter":"False negatives","value":"3.05","unit":"%","info":"131 positive samples, 4 were false negative."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.25","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.85","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"98.88","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1870","commercial_name":"Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"328","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":"www.hotgen.com.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Throat swab"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"This kit is used for in vitro qualitative determination of novel coronavirus antigen in human nasal swabs or throat swabs. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.","last_updated":"2022-09-20 14:48:19 CET","testList":[{"id_test":"3834","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"396.22","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.38","unit":"%"},{"parameter":"False negatives","value":"0.24","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.87","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.62","unit":"%"},{"parameter":"Clinical Specificity","value":"99.76","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1798","commercial_name":"Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva","manufacturer":{"id_manufacturer":"328","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":"www.hotgen.com.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"This kit is used for in vitro qualitative determination of novel coronavirus antigen in human saliva samples from posterior oropharynx. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1477","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"250"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"0"},{"parameter":"False negatives","info":"0"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.79"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"99.78","unit":"%"}]}]},{"id_device":"2809","commercial_name":"Novel Coronavirus(SARS-CoV-2) Neutralizing AntibodiesTest (Up-converting Phosphor Immunochromatographic Technology)","manufacturer":{"id_manufacturer":"1256","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":[],"notes":"Products need to pass UPT instrument testing to obtain results.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2514","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Neutralization Antibody (NAb)","detection_principle":"Phosphor technology","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.25","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.57","unit":"%","info":"869 negative samples have 5 false positives."},{"parameter":"False negatives","value":"1.17","unit":"%","info":"339 positive samples have 4 false negatives."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.25","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.82","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.42","unit":"% IgG"}]}]},{"id_device":"2811","commercial_name":"SARS-CoV-2 (S-RBD & NP) Antibody Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"1069","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":"www.hotgen.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":[],"notes":"Two test results can be obtained through this product test: S-RBD antibody and NP antibody.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2516","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"15","unit":"AU\/mL","info":"15BAU\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"408 negative samples have no false positives."},{"parameter":"False negatives","value":"0.43","unit":"%","info":"230 positive samples have 1 false negative."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.84","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.57","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"}]}]},{"id_device":"2810","commercial_name":"SARS-CoV-2 and Flu A\/B Antigen Combo Rapid Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"1256","name":"Beijing Hotgen Biotech Co. 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https:\/\/www.biobasic.com\/amfilerating\/file\/download\/file_id\/25636\/","performances":[{"parameter":"LOD","value":"1000","unit":"copies\/reaction"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2122","commercial_name":"COVID-19 ANTIGEN RAPID TEST CASSETTE","manufacturer":{"id_manufacturer":"982","name":"BIO GROUP MEDICAL SYSTEM","country":"Italy","website":"www.biogms.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":[],"notes":"The COVID-19 Antigen Rapid Test) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal\/orophayngeal\/nasal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1812","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"See IFU"},{"parameter":"False negatives","info":"See IFU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.2","unit":"%","info":" (95%CI*: 91.3%~98.7%)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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When the COVID-19 IgG antibody or IgM antibody level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen- color latex conjugate are captured by anti-human IgG antibody immobilized on the Test Region (G)of the device or anti-human IgMantibody immobilized on the Test Region(M), and This produces one or two color teststrips indicating a positive result. When theCOVID-19 IgG\/IgM antibodies level in thespecimen is zero or below the target cutoff,there is not a visible colored band in the TestRegion (G M) of the device. This indicates anegative result. To serve as a procedure control, a colored linewill appear at the Control Region (C), if the testhas been performed properly.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2408","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Chromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%","info":"0"},{"parameter":"False negatives","unit":"%","info":"0"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"% IgG"},{"parameter":"Accuracy","value":"100","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgM"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2706","commercial_name":"(COVID-19) IgM\/IgG Antibody Rapid Test Kit (Latex Chromatography)","manufacturer":{"id_manufacturer":"1236","name":"Bioantibody Biotechnology Co. 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When the sample is added to the test device, the sample will be absorbed into the device by capillary action, mixing with SARS- CoV-2 recombinant antigen-color latex conjugate and flowing through the pre-coated membrane. When the COVID-19 IgG antibody or IgM antibody level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen- color latex conjugate are captured by anti-human IgG antibody immobilized on the Test Region (G)of the device or anti-human IgMantibody immobilized on the Test Region(M), and This produces one or two color teststrips indicating a positive result. When theCOVID-19 IgG\/IgM antibodies level in thespecimen is zero or below the target cutoff,there is not a visible colored band in the TestRegion (G M) of the device. This indicates anegative result. To serve as a procedure control, a colored linewill appear at the Control Region (C), if the testhas been performed properly.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2411","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"0","unit":"% IgG"},{"parameter":"False positives","value":"1.1","unit":"% IgM"},{"parameter":"False negatives","value":"2.7","unit":"% IgG"},{"parameter":"False negatives","value":"0","unit":"% IgM"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"% IgG"},{"parameter":"Accuracy","value":"99","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"98.9","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"97.3","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgM"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3079","commercial_name":"SARS-CoV-2 Antigen Rapid Detection Kit","manufacturer":{"id_manufacturer":"1236","name":"Bioantibody Biotechnology Co. 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Mouse monoclonal anti-SARS-CoV-2 antibodies are coated on the test line region and Goat anti-chicken IgY antibodies are coated on the control region. When the specimen is processed and added to the sample well, SARS-CoV-2 antigens in the sample interact with the SARS-CoV-2 Antibody-labeled conjugate forming antigen-antibody color particle complexs .The complexs migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-SARS-CoV-2 antibodies. A colored test line is visible in the result window if SARS-CoV-2 antigens are present in the specimen and the intensity depends upon the amount of SARS-CoV-2 antigen. When the SARS-CoV-2 antigens in the specimen does not exist or is below the detection limit, there is not a visible colored band in the Test line (T) of the device. This indicates a negative result. Neither the test line nor control line are visible in the result window prior to applying the specimen. A visible control line is required to indicate the result is valid.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2409","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Chromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"INTNSSP(74-80) clone2 binding site:GTRNPANN(147-154)","performances":[{"parameter":"LOD","value":"28.8","info":"pg\/ml (Nucleocapsid protein Concentration)"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6","unit":"AU"},{"parameter":"False negatives","value":"2","unit":"AU"},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.9","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"98.11","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3081","commercial_name":"SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) (anterior nasal swab)","manufacturer":{"id_manufacturer":"1236","name":"Bioantibody Biotechnology Co. Ltd.","country":"China","website":"http:\/\/www.baikangbiotech.com\/index.php\/product\/49.html"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"no additional information","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3135","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"10","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.07","unit":"%","info":"antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90","unit":"%","info":"antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2705","commercial_name":"SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography)","manufacturer":{"id_manufacturer":"1236","name":"Bioantibody Biotechnology Co. Ltd.","country":"China","website":"http:\/\/www.baikangbiotech.com\/index.php\/product\/49.html"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) is a lateral flow chromatographic immunoassay. It has two pre-coated lines, \u201cT\u201d Test line and \u201cC\u201d Control line on the nitrocellulose membrane. Mouse monoclonal anti-SARS-CoV-2 antibodies are coated on the test line region and Goat anti-chicken IgY antibodies are coated on the control region.Mouse anti- SARS-CoV-2 antibodies conjuated with colored latex are used as detectors for SARS-CoV-2 antigen. When the specimen is processed and added to the sample well, SARS-CoV-2 antigens in the sample interact with the SARS-CoV-2 Antibody-labeled conjugate forming antigen-antibody color particle complexs .The complexs migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-SARS-CoV-2 antibodies. A colored test line is visible in the result window if SARS-CoV-2 antigens are present in the specimen and the intensity depends upon the amount of SARS-CoV-2 antigen. When the SARS-CoV-2 antigens in the specimen does not exist or is below the detection limit, there is not a visible colored band in the Test line (T) of the device. This indicates a negative result. Neither the test line nor control line are visible in the result window prior to applying the specimen. 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Antigen epitope information: N\u2010terminal domain (NTD; 46 \u2013176 aa) C\u2010terminal domain (CTD; 247\u2013364 aa)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1066","assay_category":"Immuno-Antigen","rapid_diagnostic":"No","self_test":"No","reader_required":"Yes","method":"ELISA","measurement":"Quantitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"75","performances":[{"parameter":"LOD","value":"2.97","info":"pg\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.33","unit":"%"},{"parameter":"Accuracy","info":"99.33%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.05","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2692","commercial_name":"SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Anterior Nasal Swab","manufacturer":{"id_manufacturer":"1037","name":"BIOHIT HealthCare (Hefei) Co. 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Antigene epitope information: N\u2010terminal domain (NTD; 46\u2013176 aa) C\u2010terminal domain (CTD; 247\u2013364 aa)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2397","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"12.69","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.71","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.12","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2693","commercial_name":"SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Blood","manufacturer":{"id_manufacturer":"1037","name":"BIOHIT HealthCare (Hefei) Co. 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Antigen epitope information: N\u2010terminal domain (NTD; 46 \u2013176 aa) C\u2010terminal domain (CTD; 247\u2013364 aa).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2398","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"16","performances":[{"parameter":"LOD","value":"8.92","info":"pg\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.69","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.63","unit":"%"},{"parameter":"Clinical Specificity","value":"99.72","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2230","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"1037","name":"BIOHIT HealthCare (Hefei) Co. 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This rapid kit is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1931","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"200","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.15","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.12","unit":"%"},{"parameter":"Clinical Specificity","value":"99.49","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1286","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)","manufacturer":{"id_manufacturer":"53","name":"BIOHIT HealthCare (Hefei) Co. 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Antigen epitope information: N\u2010terminal domain (NTD; 46\u2013176 aa) C\u2010terminal domain (CTD; 247\u2013364 aa)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1060","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"40","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.71","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.12","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"87","commercial_name":"SARS-CoV-2 IgM\/IgG antibody test kit (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"53","name":"BIOHIT HealthCare (Hefei) Co. 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The SARS-CoV-2 IgM\/IgG is detected by SARS-CoV-2 recombinant N protein.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"61","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"10","info":"\u03bcg\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.1","unit":"% IgM"},{"parameter":"Accuracy","value":"99.4","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.66","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"99.46","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"98.46","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2519","commercial_name":"COVID-19 Antigen Rapid Test (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"835","name":"BIOLAN HEALTH S.L.","country":"Spain","website":"www.biolanhealth.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"BIOLAN HEALTH COVID-19 Antigen Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleoclapsid antigen of SARS-CoV-2 virus in nasal swab samples in only 15-20 minutes. The product is intended for use as an aid in the rapid diagnosis of COVID-19 in individuals who are suspected of COVID-19 within the first 7 days of symptoms onset or in asymptomatic individuals in line with the in existing national, regional, and local public health and occupational health regulations and recommendations , . This test provides preliminary test results. Positive results indicate the presence of viral antigens, but do not rule out a bacterial infection or co-infection with other viruses. Negative result does not preclude SARS-CoV-2 infection and it cannot be used as a sole basis for diagnosis or patient management decisions. Negative results must be combined with clinical findings, epidemiological information and if necessary, with a molecular test.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2223","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","unit":"TCID50\/ml","info":"3,5 x 10(2,5) "},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.7","unit":"%"},{"parameter":"False negatives","value":"3.5","unit":"%","info":"(within 5 days of sympton onset). "},{"parameter":"False negatives","value":"8.4","unit":"%","info":"(7 days)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.4","unit":"%","info":"(within 5 days of symptom onset). "},{"parameter":"Accuracy","value":"94.4","unit":"%","info":" (7 days)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.5","unit":"%","info":"(within 5 days of symptom onset). "},{"parameter":"Clinical Sensitivity","value":"91.6","unit":"%","info":"( 7 days)"},{"parameter":"Clinical Specificity","value":"98.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1829","commercial_name":"COVID-19 IgG\/IgM Rapid Test Cassette","manufacturer":{"id_manufacturer":"835","name":"BIOLAN HEALTH S.L.","country":"Spain","website":"www.biolanhealth.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"Detection of neutralizing antibodies. IgG and IgM antibodies against RBD of spike protein.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1507","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"497","commercial_name":"2019-nCoV IgG\/IgM Antibody Detection Kit","manufacturer":{"id_manufacturer":"316","name":"Biolidics","country":"Singapore","website":"www.biolidics.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 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Since then various independent evaluations have been completed at various EU member state organizations. The \"COVID-19 In Vitro Diagnostic Medical Devices\" mentions that the product is not CE marked. The name of the product has been slightly changed since the first CE marking which could be the cause of this being missed. Could you please check and update the list during the next meeting of JRC? Thank you, Khasim Technical Operations Manager khasim@btnnx.com","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1711","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"210"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"% IgM"},{"parameter":"False positives","value":"3","unit":"% IgG"},{"parameter":"False negatives","value":"5","unit":"% IgM"},{"parameter":"False negatives","value":"1","unit":"% IgG"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.7","unit":"% IgM"},{"parameter":"Accuracy","value":"98.7","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.7","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"98.8","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.1","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"98.7","unit":"% IgG"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"110","commercial_name":"Rapid Response COVID-19 IgG\/IgM Test Cassette (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"62","name":"BTNX Inc.","country":"Canada","website":"www.btnx.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"77","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"Rapid diagnostic test   ","performances":[]}]},{"id_device":"2465","commercial_name":"C4Covid-19 Human","manufacturer":{"id_manufacturer":"1123","name":"C4Diagnostics","country":"France","website":"https:\/\/www.c4diagnostics.com\/fr\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null}],"target":[],"notes":"The C4Covid-19 HumanTM kit is a rapid SARS-CoV-2 ribonucleic acid (RNA) amplification test. 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The total time to yield results is at most 30 minutes.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2168","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"LAMP","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"210000","unit":"AU","info":"(2.10E5)"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.3","unit":"%"},{"parameter":"False negatives","value":"2.4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%","info":" (ribonucleic acid (RNA) amplification test)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"85","unit":"%","info":"(ribonucleic acid (RNA) amplification test)"},{"parameter":"Clinical Specificity","value":"97","unit":"%","info":"(Aribonucleic acid (RNA) amplification test)"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1647","commercial_name":"AllCheck COVID19 Ag","manufacturer":{"id_manufacturer":"738","name":"CALTH Inc.","country":"South Korea","website":"www.thecalth.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"N\/A","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3668","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"250","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Predict Postivie Value : 100.0% (95% CI : 97.2%~100.0%)"},{"parameter":"False negatives","value":"1.1","unit":"%","info":"Predict Negative Value : 98.9% (95% CI : 97.5%~99.6%))"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"95% CI : 98.4%~99.8%, 650\/656"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%","info":"95% CI : 90.6% ~98.4%, 130\/136"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI : 99.3%~100.0%, 520\/520"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2691","commercial_name":"AllCheck COVID19 Ag Nasal","manufacturer":{"id_manufacturer":"738","name":"CALTH Inc.","country":"South Korea","website":"www.thecalth.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3669","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"250","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.8","unit":"%","info":"1 case - Predict Postivie Value : 99.2% (95% CI : 95.6% - 100.0%)"},{"parameter":"False negatives","value":"1.1","unit":"%","info":"6 cases - Predict Negative Value : 98.9% (95% CI : 97.5% - 99.6%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.9","unit":"%","info":"95% CI : 98.1% - 99.7%, 643\/650"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.4","unit":"%","info":"95% CI : 90.2% - 98.3% : 124\/130"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%","info":"95% CI : 98.9% - 100.0% : 519\/520"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1999","commercial_name":"See Now Coronavirus nCoV antigen test","manufacturer":{"id_manufacturer":"918","name":"CAMP MEDICA DISTRIBUTION","country":"Romania","website":"www.campmedica.ro"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The See Now -Coronavirus nCoV Antigen test is used for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 virus in nasal swabs, nasopharyngeal swabs, oropharyngeal swabs and\/or saliva, from individuals suspected of COVID 19. See Now Coronavirus- nCoV Antigen test cannot be used as the basis to diagnose or exclude SARS-CoV-2 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1676","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"1","unit":"ng\/mL"},{"parameter":"Analytical Sensitivity","value":"97","unit":"%"},{"parameter":"Analytical Specificity","value":"99","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.17","unit":"%"},{"parameter":"Clinical Specificity","value":"99.44","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapside protein"}]}]},{"id_device":"111","commercial_name":"Camtech COVID-19 Rapid Test Kit","manufacturer":{"id_manufacturer":"415","name":"Camtech","country":"Singapore","website":"covid19-test.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"570","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Not found","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"Analysis of cross reactivity","info":"Reported"},{"parameter":"Clinical Sensitivity","value":"87.5","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1237","commercial_name":"COVID-19 Viral Antigen Test Kit","manufacturer":{"id_manufacturer":"415","name":"Camtech","country":"Singapore","website":"covid19-test.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Oropharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":" Additional info available only upon request https:\/\/covid19-test.com\/assets\/Camtech_Covid19AntigenTestKit.pdf","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1020","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":"Fluorescence","detection_principle":null,"subcategory":null,"time_minutes":"20","notes":"Rapid diagnostic test cassette Fluorescence ","performances":[{"parameter":"LOD","unit":"ng\/mL","info":"100 ng\/ml"},{"parameter":"Accuracy","value":"82.4","unit":"%"},{"parameter":"Clinical Sensitivity","value":"88.66","unit":"%"},{"parameter":"Clinical Specificity","value":"94.55","unit":"%"}]}]},{"id_device":"2948","commercial_name":"DigiGENE\u2122 COVID-19 Integrated Molecular Test","manufacturer":{"id_manufacturer":"1065","name":"Canary Global Inc.","country":"Canada","website":"www.canarydetect.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Nucleic acid"],"specimen":["Mid-turbinates swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["Other"],"notes":"Canary Global Inc\u2019s DigiGENE\u2122 COVID-19 Integrated Molecular Test Hub is an easy-to-use rapid molecular diagnostic test with cloud-based analytics to track COVID-19 spread in real- time. This test utilizes RT-LAMP technology to detect RNA of the N-gene & E-gene from SARS-CoV-2 virus. This technology can create a signal from a few copies of RNA within 20 minutes. This test consists of reusable DigiGENE Hub device and single use sample holder and sensor cartridge.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2654","assay_category":"Nucleic acid-Other","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"LAMP","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"600","unit":"copies\/ml"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Throughput","info":"Lower than 24 samples per run "}]}]},{"id_device":"2283","commercial_name":"Pelican COVID-19 Ultra-Rapid Mobile Test","manufacturer":{"id_manufacturer":"1065","name":"Canary Global Inc.","country":"Canada","website":"www.canarydetect.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Our device is equipped with dual targeting system. One sensor is coated with monoclonal antibody to SARS-CoV-2 nucleocapsid protein and another with monoclonal antibody to SARS-CoV-2 spike protein. During testing SARS-CoV-2 antigens possibly present in the specimen react with the bio receptor antibody nanoparticles present in the test. . This immunological reaction results in a digital electrical signal that is recognized by the systems software on the mobile app which results in a plus (+) sign on mobile app indicating a positive result.. If the antigens are not present in the specimen, no digital electrical signal is generated which appears as a minus (-) sign on the app indicating a negative result.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1984","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"2","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.83","unit":"%","info":"When 120 negative samples were tested, 1 sample showed false positive result"},{"parameter":"False negatives","value":"1.8","unit":"%","info":"When 111 positive samples were tested, 2 samples showed false negative result"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.7","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.2","unit":"%"},{"parameter":"Clinical Specificity","value":"99.17","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapside protein"}]}]},{"id_device":"2547","commercial_name":"SARS-CoV-2 Ultra Rapid Mobile Antigen Test","manufacturer":{"id_manufacturer":"1065","name":"Canary Global Inc.","country":"Canada","website":"www.canarydetect.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""}],"target":[],"notes":"Our device is equipped with Sensor coated system having monoclonal antibody against SARS-CoV-2 nucleocapsid protein. During testing SARS-CoV-2 antigens possibly present in the Saliva and Nasopharyngeal specimens react with the bio receptor antibodies nanoparticles present in the test. The resulting complex results in a digital electrical signal that is recognized by the systems software on the mobile app, which results in a plus (+) sign on the mobile app indicating a positive result. If the antigens are not present in the specimens, no digital electrical signal is generated which appears as a minus (-) sign on the display of the app, indicating a negative result.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2252","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"2","performances":[{"parameter":"LOD","unit":"AU","info":"100"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.83","unit":"%","info":"Saliva: 1 False Positive out of 120 Negative"},{"parameter":"False positives","value":"0.83","unit":"%","info":"Nasopharyngeal: 1 False Positive out of 120 Negative"},{"parameter":"False negatives","value":"3.6","unit":"%","info":"Saliva: 4 False Negative out of 111 Positive"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"Nasopharyngeal: 3 False Negative out of 111 Positive"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%","info":"Saliva: >99 (Antigen)"},{"parameter":"Accuracy","value":"99","unit":"%","info":"Nasopharyngeal: >99 (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"Saliva: 96.4 (Antigen)"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"Nasopharyngeal: 97.3 (Antigen)"},{"parameter":"Clinical Specificity","value":"99.17","unit":"%","info":"Saliva: 99.17 (Antigen)"}]}]},{"id_device":"112","commercial_name":"AiroStotleCV19 (Breath VOCs)","manufacturer":{"id_manufacturer":"888","name":"Canary Health Technologies","country":"United States","website":"www.canaryhealth.com"},"ce_marking":"No","commercial_status":"In 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result delivered within 35 minutes. Test report issued within 45 minutes.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2324","assay_category":"Nucleic acid-Other","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"LAMP","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"45","performances":[{"parameter":"LOD","value":"150","unit":"cpm"},{"parameter":"Throughput","info":"Lab-on-chip"}]}]},{"id_device":"2788","commercial_name":"SARS-CoV-2 Neutralizing Antibodies Test Kit","manufacturer":{"id_manufacturer":"1253","name":"CAS-Envision","country":"China","website":"www.cas-envision.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 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The assay uses a human housekeeping gene as an endogenous Internal Control (IC) (human RNase P gene) to monitor the extraction process and\/or discard the inhibition of the polymerase activity","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2073","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[{"parameter":"Positive control","info":"Yes"},{"parameter":"Negative control","info":"Yes"}]}]},{"id_device":"5817","commercial_name":"CHECK UP COVID19-INF A\/B-RSV MULTI RAPID TEST KIT","manufacturer":{"id_manufacturer":"1232","name":"Cesna Biyoteknoloji Ara\u00c5\u0178t\u00c4\u00b1rma Geli\u00c5\u0178tirme Laboratuvar 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A positive test result must be further confirmed. A negative test result cannot rule out an infection. The kit and test results are intended for clinical reference only. 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protein"],"notes":"Our Covid19 clinical assessment was conducted by PEI in 2021.\r\nIn addition, our Covid19 diagnostic kit is on the list with the number of HS common List RAT 2696.","last_updated":"2023-01-09 10:10:16 CET","testList":[{"id_test":"5422","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"3200","unit":"TCID50\/ml","info":"for Covid19"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.32","unit":"%","info":"1 out of 306"},{"parameter":"False negatives","value":"0.49","unit":"%","info":"2 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Specificity","value":"98.04","unit":"%","info":"RSV"}]}]},{"id_device":"5832","commercial_name":"CHECKUP COVID-INF A\/B-RSV-ADENO RAPID TEST KIT","manufacturer":{"id_manufacturer":"1232","name":"Cesna Biyoteknoloji Ara\u00c5\u0178t\u00c4\u00b1rma Geli\u00c5\u0178tirme Laboratuvar Sist.\u00c4\u00b0n\u00c5\u0178.M\u00c3\u00bch.Dan.San.Tic.Ltd.\u00c5\u017eti.","country":"Turkey","website":"www.cesnalaboratuvarsistemleri.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Adenovirus","Adenovirus 3","Adenovirus 7","Adenovirus Subtype B","Adenovirus Subtype C","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Anti-Nuclear Antibody","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Bordetella Pertussis","Chlamydia Pneumoniae","Coronaviruses (HCoV)","Cytomegalovirus 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protein"],"last_updated":"2023-01-10 11:26:59 CET","testList":[{"id_test":"5436","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"3200","unit":"TCID50\/ml","info":"(for Covid19)"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"99.01","unit":"%","info":"\u0131nfa"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.32","unit":"%","info":"1 out of 306"},{"parameter":"False negatives","value":"0.49","unit":"%","info":"2 out of 407"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.25","unit":"%","info":"adeno"},{"parameter":"Accuracy","value":"98.18","unit":"%","info":"\u0131nfb"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"\u0131nfa"},{"parameter":"Accuracy","value":"98.98","unit":"%","info":"rsv"},{"parameter":"Accuracy","value":"98.98","unit":"%","info":"covid19"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.03","unit":"%","info":"rsv"},{"parameter":"Clinical Sensitivity","value":"98.04","unit":"%","info":"\u0131nfa"},{"parameter":"Clinical Sensitivity","value":"98.13","unit":"%","info":"\u0131nfb"},{"parameter":"Clinical Sensitivity","value":"99.3","unit":"%","info":"covid19"},{"parameter":"Clinical Sensitivity","value":"99.26","unit":"%","info":"adeno"},{"parameter":"Clinical Specificity","value":"98.04","unit":"%","info":"rsv"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"covid19"},{"parameter":"Clinical Specificity","value":"99.04","unit":"%","info":"\u0131nfb"},{"parameter":"Clinical Specificity","value":"99.06","unit":"%","info":"adeno"}]}]},{"id_device":"2934","commercial_name":"COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1293","name":"Changchun WanCheng Bio Electron Co. Ltd.","country":"China","website":"https:\/\/jlwancheng.en.alibaba.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Saliva","Throat swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"None","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2640","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.7","unit":"%","info":"No more than 0.7%"},{"parameter":"False negatives","value":"1.5","unit":"%","info":"No more than 1.5%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.6","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.8","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2990","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Lateral Flow Method) ","manufacturer":{"id_manufacturer":"1323","name":"Changsha Sanji Bio-technology Co. 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protein"],"notes":"None","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2696","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"N.A.","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"350","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"none"},{"parameter":"False negatives","value":"0","unit":"%","info":"none"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Antigen"},{"parameter":"Clinical 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For in vitro diagnostic use. 2. This test has been authorized only for the detection of the nucleocapsid protein from SARS- CoV-2, not for any other viruses or pathogens. 3. Do not use this kit beyond the expiration date printed on the outside carton. 4. Test results are meant to be visually determined. 5. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. 6. Do not reuse any kit components. 7. Proper specimen collection is critical to the performance of this test. 8. Dispose of used test kits as biohazards waste in accordance with the local requirements.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2856","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"N.A.","detection_principle":null,"subcategory":null,"time_minutes":"30","notes":"antigen_epi N protein antibody B2 ( MAB2) aa44-aa175 N protein antibody B3 ( MAB3) aa74-aa105","performances":[{"parameter":"LOD","value":"395","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"1.6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.62","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.4","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2766","commercial_name":"Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) (For Nasal)","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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Reagents and devices must be at room temperature (15\u201330 \u00b0C) when used for testing\u3002","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2471","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"170","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.97","unit":"%"},{"parameter":"False negatives","value":"4.35","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.41","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.65","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.03","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2641","commercial_name":"Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)\uff08For Nasal)","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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Reagents and devices must be at room temperature (15\u201330 \u00b0C) when used for testing\u3002","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2346","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"170","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2749","commercial_name":"Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)\uff08For Saliva)\uff09","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. Ltd.","country":"China","website":"www.czbiowin.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":[],"notes":"1. Clinical performance was evaluated with frozen samples, and test performance may be different with fresh samples. 2. Users should test specimens as quickly as possible after specimen collection. 3. Positive test results do not rule out co-infections with other pathogens. 4.The test results should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient. 5. A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of COVID-19 infection. 6.The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 7 of illness are more likely to be negative compared to a RT-PCR assay. 7.Failure to follow the test procedure may adversely affect test performance and\/or invalid the test result. 8.The contents of this kit are to be used for the qualitative detection of SARS- CoV-2 antigens from saliva swab specimens only","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2454","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"20","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"8.11","unit":"%"},{"parameter":"False negatives","value":"0.8","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.89","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2588","commercial_name":"Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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This test has been authorized only for the detection of the nucleocapsid protein from SARS- CoV-2, not for any other viruses or pathogens. 3. Do not use this kit beyond the expiration date printed on the outside carton. 4. Test results are meant to be visually determined. 5. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. 6. Do not reuse any kit components. 7. Proper specimen collection, storage and transport are critical to the performance of this test 8. The SARS-CoV-2 external positive controls have been prepared from recombinant viral proteins and do not contain infectious material. 9. Dispose of used test kits as biohazards waste in accordance with the local requirements. 10. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS). 11. Wear suitable protection when handling the contents of this kit if it is necessary.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2873","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"170","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.7","unit":"%"},{"parameter":"False negatives","value":"4.4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%"},{"parameter":"Clinical Specificity","value":"98.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2871","commercial_name":"Novel Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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We are currently looking for Omicron clinical samples and would be happy to provide sample kits if you have any clinical sites with Omicron samples to test the kit's capabilities yourselves. Regardless, with both the prevalence of Delta and the possible issues with Omicron we hope to talk with you on how to get a CE Mark. We have a production capability in the tens of millions weekly if given proper notice. Thank you for our time and I'm happy to address any questions, clear up any issues or provide further information if desired. 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The test is intended for use in symptomatic\/asymptomatic individuals who are suspected of being infected with SARS-CoV-2 and\/or Influenza A+B. Results are for the detection of SARS-CoV-2 nucleocapsid protein, Influenza A and Influenza B nucleoproteins antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2 and\/or Influenza A+B. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 and\/or Influenza A+B infection. Individuals who test negative and continue to experience COVID-like or flu-like symptoms should seek follow up care from their healthcare provider. Test for children and young people should be used with an adult. 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Results are for the detection of SARS-CoV-2 and Influenza A+B Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19\/ Influenza A+B. 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The COVID-19 and M.pneumoniae IgG Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV-2\/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended to be used by trained laboratory personnel. Negative results will not preclude SARS-COV-2\/M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. 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COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2150","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.036","unit":"AU"},{"parameter":"False negatives","value":"0.01","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2386","commercial_name":"COVID-19 Antigen Rapid Test (Oral Fluid)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co- infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2088","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.099","unit":"AU"},{"parameter":"False negatives","value":"0.007","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.1","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2449","commercial_name":"COVID-19 Antigen Rapid Test (Swab)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Mumps Virus (MuV)","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-09-20 17:34:01 CET","testList":[{"id_test":"3844","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU","info":"Evaluated"},{"parameter":"False positives","value":"0.01","unit":"AU","info":"Nasopharyngeal Swab(Antigen)"},{"parameter":"False positives","value":"0.001","unit":"AU","info":"Nasal Swab(Antigen)"},{"parameter":"False negatives","value":"0.036","unit":"AU","info":"Nasopharyngeal Swab(Antigen)"},{"parameter":"False negatives","value":"0.039","unit":"AU","info":"Nasal Swab(Antigen)"},{"parameter":"Accuracy","value":"98.2","unit":"%","info":"Nasopharyngeal Swab(Antigen)"},{"parameter":"Accuracy","value":"98.2","unit":"%","info":"Nasal Swab(Antigen)"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"Nasopharyngeal Swab(Antigen)"},{"parameter":"Clinical Sensitivity","value":"96.1","unit":"%","info":"Nasal Swab(Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"Nasopharyngeal Swab(Antigen)"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%","info":"Nasal Swab(Antigen)"}]}]},{"id_device":"2387","commercial_name":"COVID-19 Antigen Rapid Test(Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The COVID-19 Antigen Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2089","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.036","unit":"AU"},{"parameter":"False negatives","value":"0.008","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2388","commercial_name":"COVID-19 Antigen Test Cassette  (Nasopharyngeal Swab)(FIA)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Mumps Virus (MuV)","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) is based on fluorescence immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management. The COVID-19 Antigen Test Cassette is intended for use by trained clinical laboratory personnel.","last_updated":"2022-09-20 10:40:16 CET","testList":[{"id_test":"5304","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"False positives","unit":"AU"},{"parameter":"False negatives","value":"0.0144","unit":"AU"},{"parameter":"Accuracy","value":"99.54","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Sensitivity","value":"98.56","unit":"%","info":"Evaluated"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Evaluated"}]}]},{"id_device":"1476","commercial_name":"COVID-19 Antigen Test for Self Testing","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The COVID-19 Antigen Rapid Test (Swab) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in self-collected nasal swab specimen from symptomatic \/ asymptomatic individuals who are suspected of being \r\ninfected with COVID-19. This test is designed for the use by layperson. A positive result indicates the presence of SARS-CoV-2. Individuals whose test results are positive should self-isolate and seek help from relevant healthcare institutions. A positive result may also be caused by bacterial infection or co-infection with other viruses. A negative result may also be infected with SARS-CoV-2. Individuals whose test results are negative continue to experience COVID-like symptoms should seek follow-up help from relevant healthcare institutions.The COVID-19 Antigen Rapid Test (Swab) only indicates a preliminary result. The confirmation of the final result should be based on the clinical diagnosis.","last_updated":"2022-11-07 14:09:37 CET","testList":[{"id_test":"5286","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU","info":"Evaluated"},{"parameter":"Analytical Specificity","value":"99.9","unit":"%","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False negatives","unit":"%"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97","unit":"%","info":"Evaluated"}]}]},{"id_device":"1395","commercial_name":"COVID-19 IgG Rapid Test","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1161","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"False positives","value":"4.7","unit":"%"},{"parameter":"False negatives","unit":"%","info":"5.70%"},{"parameter":"Accuracy","value":"95","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"94.3","unit":"% IgG"}]}]},{"id_device":"2441","commercial_name":"COVID-19 IgG Rapid Test (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The COVID-19 IgG Rapid Test (Whole Blood\/Serum\/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) and\/or Nucleocapsid protein in human whole blood, serum or plasma specimen. The COVID-19 IgG Rapid Test (Whole Blood\/Serum\/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2144","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.038","unit":"AU","info":"( SARS-CoV-2 infection), "},{"parameter":"False positives","value":"0.043","unit":"AU","info":"(vaccination)"},{"parameter":"False negatives","value":"0.001","unit":"AU","info":"( SARS-CoV-2 infection), "},{"parameter":"False 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blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1160","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","notes":"Rapid diagnostic test Strip  ","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"False positives","value":"5","unit":"%"},{"parameter":"False negatives","value":"5.6","unit":"%"},{"parameter":"Accuracy","value":"94.9","unit":"%"},{"parameter":"Clinical Sensitivity","value":"94.4","unit":"%"}]}]},{"id_device":"2439","commercial_name":"COVID-19 IgG\/IgM Rapid Test (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS 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blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The COVID-19 IgG\/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen from patients suspected of COVID-19 infection by a healthcare provider. The COVID-19 IgG\/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG\/IgM Rapid Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG\/IgM Rapid Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from preexisting antibodies or other possible causes.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2142","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","info":"100"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.037","unit":"% IgG"},{"parameter":"False positives","value":"0.05","unit":"% IgM"},{"parameter":"False negatives","value":"0.014","unit":"% IgG"},{"parameter":"False negatives","value":"0.02","unit":"% IgM"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"% IgG"},{"parameter":"Accuracy","value":"97.4","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.3","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"95","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"98.6","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"98","unit":"% IgM"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1475","commercial_name":"COVID-19 IgG\/IgM Test Cassette","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1224","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.3","unit":"%"},{"parameter":"False negatives","value":"3.1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.9","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.7","unit":"%","info":"(IgG\/IgM)"}]}]},{"id_device":"2393","commercial_name":"COVID-19 IgG\/IgM Test Cassette (Whole 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COVID-19 IgG\/IgM Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.The COVID-19 IgG\/IgM Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG\/IgM Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV- 2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG\/IgM Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2095","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.033","unit":"AU"},{"parameter":"False negatives","value":"0.031","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.9","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.7","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Clinical Specificity","value":"96.9","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2394","commercial_name":"SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood\/Serum\/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain of the viral spike glycoprotein (RBD) with the cell surface receptor ACE2 in human whole blood, serum or plasma. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 neutralization antibodies. Positive results indicate the presence of neutralization antibodies to SARS-CoV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2096","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.034","unit":"AU"},{"parameter":"False negatives","value":"0.015","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.7","unit":"%","info":"(Neturalization Antibody)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.6","unit":"%","info":"(Neturalization Antibody)"},{"parameter":"Clinical Specificity","value":"98.5","unit":"%","info":"(Neturalization Antibody)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1388","commercial_name":"SARS-COV-2 RT-qPCR Assay","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1154","assay_category":"Nucleic acid-PCR","rapid_diagnostic":"No","self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"100","notes":" ","performances":[{"parameter":"LOD","value":"200","unit":"AU"},{"parameter":"Positive control","info":"RAN Pseudovirus"},{"parameter":"Negative control","info":"DEPC-Treated Water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"99.14","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"99.14","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"2395","commercial_name":"SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood\/Serum\/ Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD). Positive results indicate the presence of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2097","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.022","unit":"AU"},{"parameter":"False negatives","value":"0.015","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%","info":"(Antibody)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.8","unit":"%","info":"(Antibody)"},{"parameter":"Clinical Specificity","value":"98.5","unit":"%","info":"(Antibody)"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2400","commercial_name":"SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood\/Serum\/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2102","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","unit":"AU","info":"100"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"AU","info":"0.022"},{"parameter":"False negatives","unit":"AU","info":"0.015"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"% IgG","info":"(IgG)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.8","unit":"% IgG","info":"(IgG)"},{"parameter":"Clinical Specificity","value":"98.5","unit":"% IgG","info":"(IgG)"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1474","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"  no info in company website","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1223","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Rapid diagnostic test   ","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.8","unit":"%","info":"(0.9% Influenza A; 0.9% Influenza B; 3.8% RSV)"},{"parameter":"False negatives","value":"3.6","unit":"%","info":"(5% Influenza A; 7.1% Influenza B; 5.7% RSV)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(98.4 Influenza A; 98.1 Influenza B; 95.9 RSV)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(95 Influenza A; 92.9 Influenza B; 94.3 RSV)"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"2410","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus(RSV) antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2\/Influenza\/RSV infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B and RSV Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/Influenza A+B\/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B and RSV. The SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2112","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.036","unit":"AU","info":"(SARS-CoV-2 Test), "},{"parameter":"False positives","value":"0.057","unit":"AU","info":"(RSV Test)"},{"parameter":"False positives","value":"0.071","unit":"AU","info":"(Influenza BTest), "},{"parameter":"False positives","value":"0.05","unit":"AU","info":"(Influenza A Test), "},{"parameter":"False negatives","value":"0.008","unit":"AU","info":"(SARS-CoV-2 Test), "},{"parameter":"False negatives","value":"0.038","unit":"AU","info":"(RSV Test)"},{"parameter":"False negatives","value":"0.009","unit":"AU","info":"(Influenza BTest), "},{"parameter":"False negatives","value":"0.009","unit":"AU","info":"(Influenza A Test), "},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%","info":" (Antigen-Influenza BTest), "},{"parameter":"Accuracy","value":"95.9","unit":"%","info":"(Antigen-RSV Test)"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(Antigen-SARS-CoV-2 Test), "},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"(Antigen-Influenza A Test), "},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(Antigen-SARS-CoV-2 Test), "},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"(Antigen-Influenza A Test), "},{"parameter":"Clinical Sensitivity","value":"92.9","unit":"%","info":"(Antigen-Influenza BTest)"},{"parameter":"Clinical Sensitivity","value":"94.3","unit":"%","info":"(Antigen-RSV Test)"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"(Antigen-SARS-CoV-2 Test), "},{"parameter":"Clinical Specificity","value":"99.1","unit":"%","info":"(Antigen-Influenza A Test), "},{"parameter":"Clinical Specificity","value":"99.1","unit":"%","info":"(Antigen-Influenza BTest), "},{"parameter":"Clinical Specificity","value":"96.2","unit":"%","info":"(Antigen-RSV Test)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1472","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus Antigen","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1221","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.8","unit":"%","info":"(S0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus)"},{"parameter":"False negatives","value":"3.6","unit":"%","info":"(5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(98.4 Influenza A; 98.1 Influenza B; 95.9 RSV; 98.4 Adenovirus)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(95 Influenza A; 92.9 Influenza B; 94.3 RSV; 96.9 Adenovirus)"}]}]},{"id_device":"2440","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV) and Adenovirus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2\/ Influenza\/ RSV\/Adenovirus infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV and Adenovirus antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B\/RSV\/Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B ,RSV and Adenovirus. The SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus Antigen Combo Rapid Test is intended for use by trained clinical laboratory personne","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2143","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.031","unit":"AU","info":"(Adenovirus)"},{"parameter":"False positives","value":"0.036","unit":"AU","info":"(SARS-CoV-2),"},{"parameter":"False positives","value":"0.057","unit":"AU","info":"(RSV),"},{"parameter":"False positives","value":"0.071","unit":"AU","info":"(Influenza B),"},{"parameter":"False positives","value":"0.05","unit":"AU","info":"(Influenza A),"},{"parameter":"False negatives","value":"0.009","unit":"AU","info":"(Influenza A),"},{"parameter":"False negatives","value":"0.014","unit":"AU","info":"(Adenovirus)"},{"parameter":"False negatives","value":"0.038","unit":"AU","info":"(RSV),"},{"parameter":"False negatives","value":"0.009","unit":"AU","info":"(Influenza B),"},{"parameter":"False negatives","value":"0.008","unit":"AU","info":"(SARS-CoV-2),"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.9","unit":"%","info":"(Antigen RSV),"},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"(Antigen Influenza A),"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(Antigen SARS-CoV-2),"},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"(Antigen Adenovirus)"},{"parameter":"Accuracy","value":"98.1","unit":"%","info":"(Antigen Influenza B),"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(Antigen SARS-CoV-2),"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"(Antigen Influenza A),"},{"parameter":"Clinical Sensitivity","value":"92.9","unit":"%","info":"(Antigen Influenza B),"},{"parameter":"Clinical Sensitivity","value":"94.3","unit":"%","info":"(Antigen RSV),"},{"parameter":"Clinical Sensitivity","value":"96.9","unit":"%","info":"(Antigen Adenovirus)"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"(Antigen SARS-CoV-2),"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%","info":"(Antigen Influenza A),"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%","info":"(Antigen Influenza B),"},{"parameter":"Clinical Specificity","value":"96.2","unit":"%","info":"(Antigen RSV),"},{"parameter":"Clinical Specificity","value":"98.6","unit":"%","info":"(Antigen Adenovirus)"}]}]},{"id_device":"1473","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"  no info in company website","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1222","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Rapid diagnostic test   ","performances":[{"parameter":"LOD","value":"0","unit":"AU","info":"0"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.8","unit":"%","info":"(0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus; 2% M.pneumoniae)"},{"parameter":"False negatives","value":"3.6","unit":"%","info":"(5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus;8.2% M.pneumoniae)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(98.4 Influenza A; 98.1influenza B; 95.9 RSV; 98.4 Adenovirus; 97 M.pneumoniae)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(95 Influenza A; 92.9% Influenza B; 94.3 RSV; 96.9 Adenovirus; 91.8 M.pneumoniae)"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"2401","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV), Adenovirus and M.pneumoniae antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2\/Influenza\/RSV\/Adenovirus\/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B, RSV, Adenovirus and M.pneumoniae antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of correlative antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B,RSV , Adenovirus and M.pneumoniae. The SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2103","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":null,"subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","unit":"AU","info":"100"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.082","unit":"AU","info":"(M.pneumoniae)"},{"parameter":"False positives","value":"0.036","unit":"AU","info":"(SARS-CoV-2),"},{"parameter":"False positives","value":"0.031","unit":"AU","info":"(Adenovirus),"},{"parameter":"False positives","value":"0.057","unit":"AU","info":"(RSV),"},{"parameter":"False 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B),"},{"parameter":"Accuracy","value":"97","unit":"%","info":"(Antigen-M.pneumoniae)"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(Antigen-SARS-CoV-2),"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"(Antigen-Influenza A),"},{"parameter":"Clinical Sensitivity","value":"91.8","unit":"%","info":"(Antigen-M.pneumoniae)"},{"parameter":"Clinical Sensitivity","value":"96.9","unit":"%","info":"(Antigen-Adenovirus),"},{"parameter":"Clinical Sensitivity","value":"94.3","unit":"%","info":"(Antigen-RSV),"},{"parameter":"Clinical Sensitivity","value":"92.9","unit":"%","info":"(Antigen-Influenza B),"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(Antigen-SARS-CoV-2),"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"(Antigen-SARS-CoV-2),"},{"parameter":"Clinical 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tubes"}]}]},{"id_device":"3922","commercial_name":"CNAME","manufacturer":{"id_manufacturer":"1440","name":"CMANU","country":"Italy","website":""},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Fully automated (robot)"],"target_type":["Antibody"],"specimen":["Bronchoalveolar lavage fluid"],"pathogen":["Adenovirus"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""}],"target":["angiotensin-converting enzyme 2"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3589","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"12","performances":[{"parameter":"LOD","value":"12","unit":"copies\/sample"},{"parameter":"False positives","value":"12","unit":"cpr\/cpu"},{"parameter":"False negatives","value":"12","unit":"cpr\/cpu"}]}]},{"id_device":"130","commercial_name":"Logix Smart Coronavirus disease 2019 (COVID-19)","manufacturer":{"id_manufacturer":"72","name":"Co-diagnostics","country":"United States","website":"codiagnostics.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"91","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[{"parameter":"LOD","value":"9.35","unit":"copies\/\u03bcl"},{"parameter":"Positive control","info":"positive control, proprietary blend of positive primers"},{"parameter":"Negative control","info":"no template tube"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","info":"16 microorganisms in the cross-reactivity in silico assessmenttested negative with 16 species of microorganisms100% specificity with spiked samples"},{"parameter":"Throughput","info":"single tubes"}]}]},{"id_device":"2632","commercial_name":"SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method)","manufacturer":{"id_manufacturer":"1202","name":"Cofoe Medical Technology Co. Ltd.","country":"China","website":"\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"1.When the titer of the SARS-CoV-2 culture is 2.5\u00d7105TCID50\/ml, the test result of this test card does not show a hook effect; when the concentration of the SARS-CoV-2 positive quality control product is within the range of 0.5mg\/ml, the test result of this test card does not show a hook effect . 2.Nasopharyngeal swab specimens can be stored at 2\u2103-8\u2103 for at least 8h. 3.The loading volume of theSARS-CoV-2 antigen test strip is 50\u03bcl. 4.After opening the foil bag, the SARS-CoV-2 antigen test strip meets the requirements within 60 minutes. But the test result will fail after opening for 90 minutes. Therefore, the bag-opening stability is set at 60 minutes. 5.The general storage temperature of the kit is about 25\u00b0C. According to the Arrhenius formula, the logarithm of the expiration date and the reciprocal of the absolute temperature have a linear relationship. Accelerated at 37\u00b0C for 3 months (90 days), converted to approximately 12 months (360 days) stored at 25\u00b0C. Therefore, in the absence of real-time stability test results, it is temporarily assumed that the SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) is valid for 12 months.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2337","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.1","unit":"ng\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.04","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3937","commercial_name":"SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method)","manufacturer":{"id_manufacturer":"3214","name":"Cofoe Medical Technology Co., Ltd.","country":"China","website":""},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus OC43 (HCoV-OC43)","Bordetella Pertussis","Chlamydia Pneumoniae","Hemophilus Influenzae","Influenza A","Influenza A H1N1","Parainfluenza Virus Type","Parainfluenza Virus Type 1","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Respiratory Syncytial V (RSV)","Respiratory Syncytial V (RSV) Type A","Rhinovirus"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"last_updated":"2022-11-14 09:03:04 CET","testList":[{"id_test":"5308","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"900","unit":"TCID50\/ml"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"False positives","value":"0.99","unit":"%"},{"parameter":"False 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Antigen Rapid Test is a rapid immunochromatographic method intend for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP)specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2717","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"62.5","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False 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CET","testList":[{"id_test":"573","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Rapid diagnostic test cassette Not found ","performances":[]}]},{"id_device":"1734","commercial_name":"Convergys POC RT-PCR COVID-19 Detectin Kit","manufacturer":{"id_manufacturer":"769","name":"Convergent Technologies","country":"Germany","website":"www.convergent-technologies.de"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"https:\/\/convergent-technologies.de\/product\/convergys-poc-rt-pcr-covid-19-detection-kit\/","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1413","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"90","performances":[{"parameter":"LOD","value":"250","unit":"cpm"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","info":"single cartridges"}]}]},{"id_device":"4068","commercial_name":"Convergys\u00ae COVID-19 Rapid Antigen Test","manufacturer":{"id_manufacturer":"769","name":"Convergent Technologies","country":"Germany","website":"www.convergent-technologies.de"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal 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CET","testList":[{"id_test":"3830","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"180","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"95","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.98","unit":"%"},{"parameter":"False negatives","value":"4.97","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.15","unit":"%"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.03","unit":"%"},{"parameter":"Clinical Specificity","value":"99.02","unit":"%"}]}]},{"id_device":"1594","commercial_name":"Antigen Rapid Test COVID-19 Coretests","manufacturer":{"id_manufacturer":"420","name":"Core Technology Co. Ltd.","country":null,"website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1274","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"2505","commercial_name":"Canea COVID-19 Antigen Speichel Selbsttest","manufacturer":{"id_manufacturer":"1142","name":"Core Technology Co. Ltd.","country":"China","website":"http:\/\/www.coretests.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label the COVID-19 monoclonal antibody. Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2209","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"22.5","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"100","unit":"%"},{"parameter":"False negatives","value":"100","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.7","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.6","unit":"%"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1919","commercial_name":"Coretests COVID-19 Ag Test","manufacturer":{"id_manufacturer":"420","name":"Core Technology Co. Ltd.","country":null,"website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Bordetella Pertussis","Chlamydia Pneumoniae","Hemophilus Influenzae","Human Metapneumovirus (HMPV)","Influenza A H1N1","Influenza A H3N2","Influenza A H5N1","Influenza B Victoria","Influenza B Yamagata","MERS-CoV","Mycobacterium Tuberculosis","Mycoplasma Pneumoniae","Other","Parainfluenza Virus Type 1","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Respiratory Syncytial V (RSV) Type A","Rhinovirus","SARS-CoV"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"COVID-19 Ag Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasopharyngeal swab \/ oropharyngeal swab \/ nasal swab specimen. This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody, using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the COVID-19 antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain COVID-19 antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area. Regardless of the presence of COVID-19 antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as 1.verification that sufficient volume is added. 2.That proper flow is obtained 3. And as a control for the reagents.","last_updated":"2022-10-31 09:12:45 CET","testList":[{"id_test":"5253","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"22.5","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%"},{"parameter":"False negatives","value":"18","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"91.09","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"82","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1923","commercial_name":"Coretests COVID-19 Neutralizing Ab Test","manufacturer":{"id_manufacturer":"420","name":"Core Technology Co. Ltd.","country":null,"website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"COVID-19 Neutralizing Ab Test is used for qualitative detection of the Neutralizing antibodies in patients who have recovered from Novel Coronavirus Pneumonia or those who have been vaccinated. The neutralizing antibody protects the host from infection by neutralizing the activity of the virus. It is a specific antibody that can block the virus from invading cells. The neutralizing antibody is produced by the immune response after a person is vaccinated or infected with a virus. Its titer will directly determine the body's ability to neutralize the virus, that is, the body's ability to avoid virus infection. Coretests\u00ae COVID-19 Neutralizing Ab Test can detect neutralizing antibodies faster, and the test only takes 10-15 minutes.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1599","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","unit":"AU","info":"25"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%","info":"0.7%"},{"parameter":"False negatives","unit":"%","info":"0.8%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","unit":"%","info":"99.3"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","unit":"%","info":"99.2"},{"parameter":"Clinical Specificity","unit":"%","info":"99.3"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"3025","commercial_name":"Coretests \u00ae COVID-19 Ag Test","manufacturer":{"id_manufacturer":"420","name":"Core Technology Co. Ltd.","country":null,"website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"COVID-19 Ag Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasal swab specimen.This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody. Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the COVID-19 antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain COVID-19 antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area .Regardless of the presence of COVID-19 antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as 1.verification that sufficient volume is added. 2.That proper flow is obtained 3. And as a control for the reagents.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2731","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"22.5","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.1","unit":"%"},{"parameter":"False negatives","value":"1.3","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.1","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"132","commercial_name":"COVID-19 IgM\/IgG Ab Test","manufacturer":{"id_manufacturer":"420","name":"Core Technology Co. Ltd.","country":null,"website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"575","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Not found","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Rapid diagnostic test cassette Not found ","performances":[]}]},{"id_device":"1915","commercial_name":"COVID-19 Saliva Ag Test","manufacturer":{"id_manufacturer":"420","name":"Core Technology Co. Ltd.","country":null,"website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1592","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"22.5","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.9","unit":"%"},{"parameter":"False negatives","value":"2.4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.7","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.6","unit":"%"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2967","commercial_name":"COVID-19 Ag Test","manufacturer":{"id_manufacturer":"1311","name":"CORETEST, INC.","country":null,"website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":null,"specimen":null,"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"COVID-19 Ag Test is the chromatographic assay test used for qualitative detection of the COVID-19 nucleoprotein antigen in nasal swab specimen from suspected patients may infected COVID-19. It is intended to be used in self-testing. COVID-19 Ag Test provides preliminary test results. And negative results don\u2019 t preclude COVID-19 Ag infection. The test kit cannot be used as the sole basis for treatment or other management decision. For in vitro diagnostic use only. People under the age of 15 should be tested by a guardian, and people over 70 years old should seek help from others for swab specimen collection. If the test result is negative but still with the present symptoms, it is recommended to consult a doctor for confirmation in time.A nasal swab sample can be self-collected by an individual aged 15-70 years. People are unable to collect samples by themselves may be assisted by other adults. Infants or small children should be tested by medical staff. The test is suitable for symptomatic and asymptomatic patients. It is recommended for symptomatic patients.","last_updated":"2022-12-02 09:22:17 CET","testList":[]},{"id_device":"2648","commercial_name":"Covid-19 Ag K-SeT","manufacturer":{"id_manufacturer":"73","name":"Coris BioConcept","country":"Belgium","website":"www.corisbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""}],"target":["nucleocapsid protein"],"notes":"New clinical validation on 174 samples (36 positives and 138 negatives versus PCR. 1 false negative observed.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2353","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"140","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%","info":"New clinical validation on 174 samples (36 positives and 138 negatives versus PCR. 1 false negative observed"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.2","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"133","commercial_name":"COVID-19 Ag Respi-Strip","manufacturer":{"id_manufacturer":"73","name":"Coris BioConcept","country":"Belgium","website":"www.corisbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":[],"notes":"New data is the positivity on OMICRON variant (real data, not bioinformatic)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"92","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"5000","unit":"TCID50\/ml"},{"parameter":"LOD","value":"0.25","unit":"ng\/mL"},{"parameter":"Calibration","info":"Not Reported"},{"parameter":"Analysis of cross reactivity","info":"Cross-reactivity: no cross-reactivity for bacteria and virus tested including seasonal Coronaviruses (HKU1, 229E, OC43, NL63), positive for SARS-CoV"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Clinical Sensitivity","value":"91.2","unit":"%"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%"}]}]},{"id_device":"2002","commercial_name":"COVID-19 Sero NP\/RBD","manufacturer":{"id_manufacturer":"73","name":"Coris BioConcept","country":"Belgium","website":"www.corisbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"notes":"Assay evaluated with Anti-SARS-CoV-Verification Panel for Serology Assays (NIBSC code: 20\/B770): 100% Accuracy. Test identifies antibodies against Nucleoprotein (NP Line) and against RBD domain of the spike protein (RBD line).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1679","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"10","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"No false positivity with seasonal coronaviruses HCoV-HKU1, -NL63, -OC43, and -229E"},{"parameter":"False negatives","value":"1.47","unit":"%","info":"(4 on 271 samples)"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98.4","unit":"%","info":"(combined NP and RBD)"},{"parameter":"Clinical Specificity","value":"98.5","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1810","commercial_name":"CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT","manufacturer":{"id_manufacturer":"579","name":"CORMAY","country":"Poland","website":"cormay.pl\/index.php?lang=_en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Fully functional kit contains: cassettes, swabs, extraction buffers, extraction tubes, nozzles with filters and clear IFU.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1489","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1.25","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"-"},{"parameter":"False negatives","info":"-"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"}]}]},{"id_device":"1074","commercial_name":"Cormay Rapid SARS-CoV-2 IgG\/IgM Ab","manufacturer":{"id_manufacturer":"579","name":"CORMAY","country":"Poland","website":"cormay.pl\/index.php?lang=_en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"852","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Chromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"Accuracy","value":"97.72","unit":"% IgM"},{"parameter":"Accuracy","value":"98.52","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"96.52","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"94.07","unit":"% IgM"}]}]},{"id_device":"341","commercial_name":"CoronaCide","manufacturer":{"id_manufacturer":"222","name":"CoronaCide","country":"United States","website":"www.coronacide.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"284","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"Rapid diagnostic test   ","performances":[]}]},{"id_device":"134","commercial_name":"2019-nCoV Prep Free QPCR Assay","manufacturer":{"id_manufacturer":"856","name":"Coyote Bioscience Co. 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09:08:01 CET","testList":[{"id_test":"2280","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"1x102 tcid50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","unit":"AU"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.6","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.3","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%","info":"(>99,9)"},{"parameter":"Type of antigen","info":"Nucleocapsid 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IgG-Spike erfasst sowohl die Immunreaktion auf SARS-CoV-2-Infektionen als auch auf SARS-CoV-2-Impfungen. 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ImmunoAssay (ELISA) for the determination of inhibition activity of RBD-ACE2 binding induced by antibodies to SARS-CoV-2 in human plasma and sera. The assay is intended for: (a) Confirmation of anti RBD antibodies neutralizing activity in patients positively recovered from COVID-19 showing antibodies to RBD\/Spike; (b) Testing human donors, recovered from COVID-19 infection, positive for anti-RBD\/Spike antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (c) Screening of vaccinated individuals to assure a reliable positive and efficient immunization with development of high titer neutralizing anti RBD\/Spike IgG antibodies.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2165","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"ELISA","measurement":"Quantitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"115","performances":[{"parameter":"LOD","value":"2","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"No false positive reactions were observed"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negative result was found"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2455","commercial_name":"COVID-19 IgA","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["IgA"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Enzyme ImmunoAssay (ELISA) for the determination of IgA antibodies to COVID19 in human plasma and sera. The IgA assay is recommended, in addition to IgG and IgM, to: a) monitor the global immunological response of patients undergoing an acute infection and their follow-up to full recovery; b) test patients with symptoms of the gastro enteric form of COVID-19 infection, expected to generate IgA in a quite early stage of infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2158","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"ELISA","measurement":"Semiquantitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"105","performances":[{"parameter":"LOD","value":"2","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Common autoantibodies in Autoimmune Diseases did not generate false positive results"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negative result was found"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"537","commercial_name":"COVID-19 IgG","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Microplates are coated with recombinant Nucleocapsid and Spike antigens specific to COVID-19","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"453","assay_category":"Immuno-Antibody","rapid_diagnostic":"No","self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Quantitative","subclass":null,"detection_principle":"Fluorescence","subcategory":null,"time_minutes":"105","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapside and Spike"}]}]},{"id_device":"539","commercial_name":"COVID-19 IgG Confirmation","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Module-based Enzyme-Immuno-Assay (ELISA) for the confirmation of samples positive for IgG antibodies to COVID-19 in first screening. The test can be used in addition to identify the specificity of antibodies to the major immunodominant COVID-19 antigens","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"455","assay_category":"Immuno-Antibody","rapid_diagnostic":"No","self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Quantitative","subclass":null,"detection_principle":"Fluorescence","subcategory":null,"time_minutes":"105","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2461","commercial_name":"COVID-19 IgG\/IgM Confirmation and Typing","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["IgG","IgM"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Module-based Enzyme-Immuno-Assay (ELISA) for the confirmation of samples positive for IgG and IgM antibodies to COVID-19 in first screening. The test is particularly useful in monitoring patients, infected by COVID-19, from the time of symptoms offset up to full recovery. The test can be used in addition to identify (a) the specificity (\u201ctyping\u201d) of antibodies to the major immunodominant COVID-19 antigens and (b) identify those samples with a titer of \u201cpotentially\u201d neutralizing IgG to Spike antigens such to select the donor as a candidate for immunotherapy, as well.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2164","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"ELISA","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"105","performances":[{"parameter":"LOD","value":"2","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"No false positive reactions were observed"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negative result was found"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"538","commercial_name":"COVID-19 IgM","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes 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kit is intended for the monitoring of the immune response to COVID-19 in the early stage of the infection as an additional marker to PCR","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"454","assay_category":"Immuno-Antibody","rapid_diagnostic":"No","self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Semiquantitative","subclass":null,"detection_principle":"Fluorescence","subcategory":null,"time_minutes":"105","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"}]}]},{"id_device":"2460","commercial_name":"COVID-19 RNA Vs 2","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes 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swab","Sputum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Multiplex Real-Time RT-PCR kit for the specific detection of SARS-CoV-2 in human samples by simultaneous retrotranscription and amplification of specific target region of Sars-CoV-2 genome (RdRp gene and N gene). In the same reaction tube an endogenous human gene is used as extraction\/amplification reaction control (Internal Control).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2163","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Semiquantitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"75","performances":[{"parameter":"LOD","value":"750","unit":"copies\/ml"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2456","commercial_name":"COVID-19 Spike 1&2 IgG","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["IgG"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Enzyme ImmunoAssay (ELISA) for the determination of IgG antibodies to COVID-19 Spike antigens in human plasma and sera. The IgG assay is intended for testing: (a) health-care workers at risk of COVID-19 infection to verify whether or not they might be positive for potentially neutralizing anti Spike IgG; (b) normal population for epidemiology studies on presence of potential \u201cprotective\u201d IgG to COVID-19 Spike antigens; (c) PCR-negative infected individuals, successfully recovered from infection, to assure presence of potentially neutralizing antibodies; (d) human donors, recovered from COVID-19 infection, positive for anti-Spike IgG for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (e) vaccinated individuals to assure a reliable positive immunization with development of anti Spike IgG antibodies","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2159","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"ELISA","measurement":"Quantitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"105","performances":[{"parameter":"LOD","value":"2","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"None"},{"parameter":"False negatives","value":"0","unit":"%","info":"None"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Spike 1&2"}]}]},{"id_device":"2479","commercial_name":"DIA.CHEMILUX SARS-CoV-2 ACE2-RBD NEUTRALIZATION","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Fully automated (robot)"],"target_type":["IgG"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Chemi-Luminescence ImmunoAssay (CLIA) for the serological determination of the neutralization activity of antibodies to SARS-CoV-2, induced by natural infection and\/or vaccination, able to block the interaction of Receptor Binding Domain (RBD) and ACE2 and thus the virus infection. The assay is intended for testing sera and plasma collected from: (a) PCR-negative Covid-19 individuals successfully recovered from infection, to assure presence of anti RBD neutralizing antibodies; (b) human donors, recovered from COVID-19 infection, positive for anti-RBD antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (c) vaccinated individuals to assure a reliable and efficient immunization with development of neutralizing antibodies able to block ACE2-RBD binding","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2182","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"CLIA","measurement":"Quantitative","subclass":null,"detection_principle":"Chemiluminescence","subcategory":null,"time_minutes":"23","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"No false positive reaction was observed"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negative result was found"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Other (RDB)"}]}]},{"id_device":"2477","commercial_name":"DIA.CHEMILUX SARS-CoV-2 NCP IgA","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Fully automated (robot)"],"target_type":["IgA"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The kit is intended for monitoring of infected patients. In addition, the kit may be used when testing the population and health-care workers looking for potentially infective \u201cpauci\u201d or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2180","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"CLIA","measurement":null,"subclass":null,"detection_principle":"Chemiluminescence","subcategory":null,"time_minutes":"35","performances":[{"parameter":"LOD","value":"2","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Common autoantibodies in Autoimmune Diseases did not generate false positive results"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negative result was found"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2463","commercial_name":"DIA.CHEMILUX SARS-CoV-2 NCP IgG","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Fully automated (robot)"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Chemi-Luminescence ImmunoAssay (CLIA) for the semi-quantitative determination of IgG antibodies to SARS-CoV-2 Nucleocapsid protein (NCP) in human plasma and sera. The kit is intended for monitoring of infected patients. In addition the kit may be used when testing the population and health-care workers looking for potentially infective \u201cpauci\u201d or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2166","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"CLIA","measurement":"Quantitative","subclass":null,"detection_principle":"Chemiluminescence","subcategory":null,"time_minutes":"35","performances":[{"parameter":"LOD","value":"2","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Common autoantibodies in Autoimmune Diseases did not generate false positive results"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negative result was found"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2464","commercial_name":"DIA.CHEMILUX SARS-CoV-2 NCP IgM","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Fully automated (robot)"],"target_type":["IgM"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Ensayo inmunoquimioluminiscente (CLIA) para la determinaci\u00f3n semicuantitativa de anticuerpos IgM para la prote\u00edna de la nucleoc\u00e1pside (NCP) del SARS-CoV-2 en plasma y suero humanos. El equipo est\u00e1 destinado para el seguimiento de pacientes infectados. Adem\u00e1s, el equipo puede utilizarse al realizar pruebas a la poblaci\u00f3n y al personal sanitario en busca de individuos \"pauci\" potencialmente infecciosos o asintom\u00e1ticos en la fase inicial de la infecci\u00f3n, en combinaci\u00f3n con las pruebas moleculares del SARS-COV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2167","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"CLIA","measurement":null,"subclass":null,"detection_principle":"Chemiluminescence","subcategory":null,"time_minutes":"35","performances":[{"parameter":"LOD","value":"2","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Common autoantibodies in Autoimmune Diseases did not generate false positive results"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negative result was found"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2478","commercial_name":"DIA.CHEMILUX SARS-CoV-2 Spike\/RBD Ab","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Fully automated (robot)"],"target_type":["IgG"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The Antibody assay is intended for testing: (a) health-care workers at risk of COVID-19 infection to verify whether or not they might be positive for potentially neutralizing anti Spike\/RBD antibodies. (b) normal population for epidemiology studies on presence of potential \u201cprotective\u201d Antibodies to SARS-CoV-2 Spike\/RBD; (c) PCR-negative infected individuals, successfully recovered from infection, to assure presence of potentially neutralizing antibodies; (d) human donors, recovered from COVID-19 infection, positive for anti-Spike\/RBD antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (e) vaccinated individuals to assure a reliable positive immunization with development of anti Spike\/RBD antibodies","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2181","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"CLIA","measurement":"Quantitative","subclass":null,"detection_principle":"Chemiluminescence","subcategory":null,"time_minutes":"23","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"No false positive reaction was observed"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false reactivity was found"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Other (Spike protein, RDB protein)"}]}]},{"id_device":"2457","commercial_name":"SARS-CoV-2 Antigen","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"}],"target":[],"notes":"Immunochromatographic Rapid Test for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab of individuals suspected of COVID-19 in acute phase or with symptoms typical of such disease","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2160","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"800","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"None"},{"parameter":"False negatives","value":"0","unit":"%","info":"None"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2466","commercial_name":"VZV DNA QUANTITATION (QT)","manufacturer":{"id_manufacturer":"341","name":"DIA.PRO Diagnostic Bioprobes Srl","country":"Italy","website":"www.diapro.it"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Semi-automated"],"target_type":["Nucleic acid"],"specimen":["Other","Plasma"],"pathogen":[],"lineage":[],"target":[],"notes":"ORF31 gene, CEREBROSPINAL FLUID","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2169","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"RT-PCR","measurement":"Quantitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"75","performances":[{"parameter":"LOD","value":"0.5","unit":"copies\/\u03bcl"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"SPECIFICITY PERCENT 100%"},{"parameter":"False negatives","info":"SENSITIVITY PERCENT 100%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"3035","commercial_name":"Quantivirus Anti-SARS-CoV-2 IgG Test","manufacturer":{"id_manufacturer":"1328","name":"Diacarta Inc.","country":"United States","website":"https:\/\/www.diacarta.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated"],"target_type":["IgG"],"specimen":["Plasma","Serum","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[],"target":["spike 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The key stage of the test is the detection of the viral genetic material, which takes place in the process of reverse transcription and isothermal amplification of the genetic material (Reverse Transcription Loop Mediated Isotermal Amplification).","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2312","assay_category":"Nucleic acid-Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"LAMP","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"10","unit":"cpr","info":"\u226510 cpr"},{"parameter":"Positive control","value":"97","unit":"%","info":"\u226597%"},{"parameter":"Negative control","value":"100","unit":"%"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"}]}]},{"id_device":"472","commercial_name":"Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A B","manufacturer":{"id_manufacturer":"293","name":"DNA Software Inc.","country":"United States","website":"www.dnasoftware.com\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"381","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"542","commercial_name":"FAST RT-PCR KIT, Real time PCR kit for COVID19 detection","manufacturer":{"id_manufacturer":"333","name":"DNA Xperts Pvt Ltd.","country":"India","website":"dnaxperts.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"442","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"1109","commercial_name":"SARS-CoV-2\/SARS-CoV Multiplex REAL-TIME PCR Detection Kit","manufacturer":{"id_manufacturer":"592","name":"DNA-Technology R&D LLC","country":"Russia","website":"site.dna-technology.ru\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"http:\/\/site.dna-technology.ru\/files\/images\/instructions_eng\/617-2_SARS-CoV,%20SARS-CoV-2%20Multiplex_%D0%92%D0%9A_S_IVD_b_CE_2020-05-07.pdf; samples: RNA extracted from nasopharynx and oropharynx swabs, bronchoalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, sputum  http:\/\/site.dna-technology.ru\/eng\/new\/1\/32.html","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"887","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"40","notes":" information provided by manufacturer +website (http:\/\/site.dna-technology.ru\/files\/images\/instructions_eng\/617-2_SARS-CoV,%20SARS-CoV-2%20Multiplex_%D0%92%D0%9A_S_IVD_b_CE_2020-05-07.pdf)","performances":[{"parameter":"LOD","value":"10","unit":"copies\/reaction"},{"parameter":"Positive control","info":"Positive control included. 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This update is based on a recent update of the corresponding technical documentation. ID2647 is the home-use version of the professional test ID2273. We have submitted an update to its section on detected virus variants, too. 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evaluated"},{"parameter":"Accuracy","value":"98.79","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98.56","unit":"%"},{"parameter":"Clinical Specificity","value":"99.38","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1717","commercial_name":"Epithod SARS-CoV-2 qAg Test Kit","manufacturer":{"id_manufacturer":"763","name":"DxGen Corp.","country":"South Korea","website":"www.dxgenco.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 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Ltd.","country":"South Korea","website":"www.eudipia.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"670","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" http:\/\/www.eudipia.com\/","performances":[]}]},{"id_device":"1739","commercial_name":"EBS SARS-CoV-2 Ag Rapid Test","manufacturer":{"id_manufacturer":"294","name":"Eurobio Scientific","country":"France","website":"https:\/\/www.eurobio-scientific.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"EBS1020, EBS SARS-CoV-2 Ag Rapid Test","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1417","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"95","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.7","unit":"%","info":"A\/(A+C) x 100= 95.7% (95% CI 90.2 98.1%)"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"2867","commercial_name":"EurobioPlex SARS-CoV-2 Fast-SVD","manufacturer":{"id_manufacturer":"294","name":"Eurobio Scientific","country":"France","website":"https:\/\/www.eurobio-scientific.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":["Nucleic acid"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["spike protein"],"notes":"SARS-CoV-2 general performance: General sensitivity: > 99% (269\/269) General specificity: > 99% (570\/570) General concordance: > 99% (839\/839) Mutations performance: K417N sensitivity: > 99% (165\/165) K417N specificity: > 99% (104\/104) K417N concordance: > 99% (269\/269) L452R sensitivity: > 99% (91\/91) L452R specificity: > 99% (178\/178) L452R concordance: > 99% (269\/269) E484K sensitivity : > 99% (168\/168) E484K specificity : > 99% (101\/101) E484K concordance : > 99% (269\/269) Detection limitation\/analytical sensitivity on CP: SARS-CoV-2 : 5 copies\/\u03bcL K417N mutation : 5 copies\/\u03bcL L452R mutation : 5 copies\/\u03bcL E484K mutation : 5 copies\/\u03bcL IC Cy5 : 10 copies\/\u03bcL No aspecificity or cross reaction was detected. The kit is 100% specific.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2572","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":"No","reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"47","performances":[{"parameter":"LOD","value":"5","unit":"copies\/\u03bcl","info":"mutation K417N"},{"parameter":"LOD","value":"5","unit":"copies\/\u03bcl","info":"mutation L452R"},{"parameter":"LOD","value":"5","unit":"copies\/\u03bcl","info":"mutation E484K"},{"parameter":"LOD","value":"5","unit":"copies\/\u03bcl","info":"SARS-CoV-2 general "},{"parameter":"LOD","value":"10","unit":"copies\/\u03bcl","info":"IC Cy5"},{"parameter":"Accuracy","value":"99","unit":"%","info":"269\/269 concordance for mutation E484K"},{"parameter":"Accuracy","value":"99","unit":"%","info":"269\/269 concordance for mutation 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"}]}]},{"id_device":"473","commercial_name":"EurobioPlex SARS-CoV-2 Multiplex","manufacturer":{"id_manufacturer":"294","name":"Eurobio Scientific","country":"France","website":"https:\/\/www.eurobio-scientific.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"  the kit exists on the website but no info can be extracted","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"382","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" https:\/\/www.eurobio-scientific.com\/","performances":[]}]},{"id_device":"2275","commercial_name":"EurobioPlex SARS-CoV-2 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The kit should be regarded as \u201cprofessional use only\u201d and should only be used by trained personal. The kit should be regarded as \u201cfor in-vitro diagnostic use only\u201d.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2371","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2665","commercial_name":"IFU NovaPrime IVD RNA Extraction AE1 RTU","manufacturer":{"id_manufacturer":"1219","name":"Eurofins GeneScan Technologies GmbH","country":"Hungary","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Semi-automated"],"target_type":null,"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Other","Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"1. Description of the kit The GSD NovaPrime IVD RNA Extraction AE1 RTU kit was designed to extract RNA from SARS-CoV-2 viruses with automated extraction instruments such as the KingFisher Flex from Thermo Scientific, Maelstrom 9600 from TAN Bead, the Auto-Pure96 Nucleic Acid Purification System from Allsheng or the AU1001-96 from BioTeke. The kit contains all buffers and chemicals for the RNA extraction procedure and yields RNA of high quality and quantities suitable for further analytical downstream applications (e.g. RT qPCR), Molecular grade solvents (Ethanol and Isopropanol), as well as plastic consumables have to be provided by the testing laboratory. 2. Purpose and Scope of the kit The kit can be used to extract viral RNA from SARS-CoV-2 virus from clinical swabs (such as dry clinical swabs) and their transport medium (such as universal transport medium). The kit can also be used with gargling solution of 0.9% NaCL and crude saliva samples as sample matrix. 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The kit should be regarded as \u201cfor in-vitro diagnostic use only\u201d.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2370","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2664","commercial_name":"NovaPrime IVD RNA Extraction AE1","manufacturer":{"id_manufacturer":"1219","name":"Eurofins GeneScan Technologies GmbH","country":"Hungary","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Semi-automated"],"target_type":null,"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Other","Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"1. Description of the kit The GSD NovaPrime IVD RNA Extraction AE1 was designed to extract RNA from SARS-CoV-2 viruses with automated extraction instruments such as the KingFisher Flex from Thermo Scientific, Maelstrom 9600 from TAN Bead, the Auto-Pure96 Nucleic Acid Purification System from Allsheng or the AU1001-96 from BioTeke. The kit contains all buffers and chemicals for the RNA extraction procedure and yields RNA of high quality and quantities suitable for further analytical downstream applications (e.g. RT qPCR), Molecular grade solvents (Ethanol and Isopropanol), as well as plastic consumables have to be provided by the testing laboratory. 2. Purpose and Scope of the kit The kit can be used to extract viral RNA from SARS-CoV-2 virus from clinical swabs (such as dry clinical swabs) and their transport medium (such as universal transport medium). The kit can also be used with gargling solution of 0.9% NaCL and crude saliva samples as sample matrix. 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The kit should be regarded as \u201cfor in-vitro diagnostic use only\u201d.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2369","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":"N.A.","method":"Other","measurement":"N.A.","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2458","commercial_name":"INGEZIM COVID 19 SPIKE CROM","manufacturer":{"id_manufacturer":"1121","name":"EUROFINS INGENASA","country":"Spain","website":"https:\/\/ingenasa.eurofins-technologies.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Serum","Whole 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CET","testList":[{"id_test":"1025","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"antigen_epi Clone #2F4 for gold dye, Clone #3C3 for capture(membrane). Based on the Epitope Mapping Results, the target epitope is presented below; (Reference: NCBI Reference Sequence ID: NC_045512.2, Domain CDS 28274 to 29533; Nucleocapsid phosphoprotein) 1) Clone #2F4 258P, 260Q, 261K, 262R, 263T, 264A. 265T, 266K, 269N, 273A, 286F, 294Q, 296T, 297D, 298Y, 302P, 305A, 306Q, 311A, 312S, 313A, 316G, 335G, 340D, 343D, 356H 2) Clone #3C3 3D, 114G, 262R, 264A, 322M, 323E, 324V, 325T, 326P, 329T, 335G, 340D, 346F, 348D, 350V, 355K, 365P -Conclusion Both #2F4 and #3C3 recognize conformational epitope as below; #2F4 : PQKRTTKNAQTDYPAQASAGGDDH #3C3 : DGRAMEVTPTGDFDVKP","performances":[{"parameter":"LOD","value":"507","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.91","unit":"%","info":"3\/103"},{"parameter":"False 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Applied Uracil-DNA N-glycosylase (UNG) system, No more carry-over contamination. Able to detect new variant OMICRON, as well as major variants that are found so far (Alpha, Beta, Gamma, Delta, etc.)","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2545","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"120","performances":[{"parameter":"LOD","value":"95","unit":"%"},{"parameter":"Positive control","info":"Mixture of RdRP, S, N, E and RNase P plasmids"},{"parameter":"Negative control","info":"Nuclease-Free Water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%","info":"100"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"100"}]}]},{"id_device":"2524","commercial_name":"COV19-ID Kit","manufacturer":{"id_manufacturer":"1151","name":"genedrive","country":"United Kingdom","website":"www.genedrive.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC","Semi-automated"],"target_type":null,"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Simple, rapid POC test with early positive detection (from 7.5 mins). 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Looks like that the tick marks in the electronic form were not taken over. 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It is ideal for children, nurseries, playschools, schools and in the private sector.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1945","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Other","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"97.12","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.88","unit":"%","info":"95,65%"},{"parameter":"False negatives","value":"1.56","unit":"%","info":"98,44%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1314","commercial_name":"V-CHEK SARS-CoV-2 Ag Rapid Test Kit","manufacturer":{"id_manufacturer":"382","name":"Guangzhou Decheng Biotechnology Co. 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The reaction complex moves along the nitrocellulose membrane under the action of chromatography. It is then captured by the anti-2019-nCoV monoclonal antibody pre-coated in the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1562","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"%"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"A reaction time of less than 15 minutes may lead to a false negative result"},{"parameter":"False negatives","info":"A reaction time of more than 15 minutes may lead a false positive result."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.12","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.65","unit":"%"},{"parameter":"Clinical Specificity","value":"98.44","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1326","commercial_name":"V-CHEK, 2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay)","manufacturer":{"id_manufacturer":"382","name":"Guangzhou Decheng Biotechnology Co. 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The following substances, which are naturally present in respiratory specimens or may be artificially introduced into the nasal cavity or nasopharynx, were evaluated at the following concentrations during the SARS-CoV-2 antigen rapid test and found that they did not affect the test performance: 5 mg\/mL Human blood (EDTA anticoagulated), 5 mg\/mL Mucin, 5 mg\/mL Oseltamivir phosphate, 5 mg\/mL Ribavirin, 5 mg\/mL Levofloxacin, 5 mg\/mL Azithromycin, 5 mg\/mL Meropenem, 5 mg\/mL Tobramycin, 20% (v\/v) Phenylephrine, 20% (v\/v) . Oxymetazoline, 20% (v\/v) 0.9% sodium chloride, 20% (v\/v) A natural soothing ALKALOL, 20% (v\/v) Beclomethasone, 20% (v\/v) Triamcinolone, 20% (v\/v) Budesonide, 20% (v\/v) Mometasone, 20% (v\/v) Fluticasone, 20% (v\/v) Fluticasone propionate","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2800","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"120","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.78","unit":"%"},{"parameter":"False negatives","value":"0.79","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.22","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"97.67","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.48","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"199","commercial_name":"Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM\/IgG Antibody","manufacturer":{"id_manufacturer":"118","name":"Guangzhou Fenghua Bioengineering Co. 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This kit is designed with specific primers and Taqman probes for the New Coronavirus ORF1ab and the conservative region of the N gene sequence encoding the nucleocapsid protein of the new coronavirus to diagnose or differentially diagnose whether the tested patient is infected with the new coronavirus, the British B.1.1.7 strain-specific N501Y mutation site and the South African B.1.351 and Brazilian P2 B.1.1.28.P2 strain-specific E484K mutation sites.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2148","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"RT-PCR","measurement":"Quantitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"45","performances":[{"parameter":"LOD","value":"500","unit":"cpm"},{"parameter":"Positive control","info":"yes"},{"parameter":"Negative control","info":"yes"},{"parameter":"Analytical Sensitivity","value":"100"},{"parameter":"Analytical Specificity","value":"100"},{"parameter":"Clinical Sensitivity","value":"100"},{"parameter":"Clinical Specificity","value":"100"}]}]},{"id_device":"1172","commercial_name":"Anti-COVID-19 virus IgM\/IgG Test Kit (lateral flow assay)","manufacturer":{"id_manufacturer":"616","name":"H&Z Life Science Co. 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samples"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.53","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.58","unit":"%"},{"parameter":"Clinical Specificity","value":"99.67","unit":"%"}]}]},{"id_device":"4160","commercial_name":"SARS-CoV-2 Rapid Antigen Test Kit (RAT-01)","manufacturer":{"id_manufacturer":"1234","name":"HA TECH PTY Ltd.","country":"Australia","website":"https:\/\/ha-tech-ltd.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Nasal 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TECH SARS-CoV-2 RT-PCR Multiplex Diagnostic Kit is a real time RT-PCR test intended for the qualitative detection of RNA from the SARS-CoV-2 virus in upper respiratory specimens such as nasopharyngeal swabs, oropharyngeal swabs and saliva. The primers and probes in this assay are designed based on the gene sequences of ORF1ab gene, N gene, and E gene in the 2019 novel coronavirus (SARS-CoV-2) genome. The product is manufactured in Australia and also TGA approved (ARTG 351643) (https:\/\/www.tga.gov.au\/covid-19-test-kits-included-artg-legal-supply-australia). Also listed in 360dx.com website (CE Mark). https:\/\/www.360dx.com\/coronavirus-test-tracker-launched-covid-19-tests","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2403","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"45","performances":[{"parameter":"LOD","value":"0.8","unit":"cpu"},{"parameter":"Positive control","info":"Positive control (purified SARS-CoV-2 genomic RNA) provides a reverse transcription and PCR contr"},{"parameter":"Negative control","info":"The NTC is Nuclease-free water and must be included in each assay"},{"parameter":"Analytical Sensitivity","value":"95","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"96.67","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"207","commercial_name":"SARS-COV-2 test","manufacturer":{"id_manufacturer":"125","name":"Hackensack Meridian Health CDI","country":"United States","website":"hmh-cdi.org\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"164","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"726","commercial_name":"CDI Enhanced COVID-19 Test","manufacturer":{"id_manufacturer":"433","name":"Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory","country":"United States","website":"www.hackensackumc.org\/services\/laboratory-services\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"591","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2972","commercial_name":"FluoroType\u00ae SARS-CoV-2 evo","manufacturer":{"id_manufacturer":"1279","name":"Hain Lifescience a Bruker company","country":"Germany","website":"https:\/\/www.bruker.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Semi-automated"],"target_type":null,"specimen":["Other"],"pathogen":["SARS-CoV"],"lineage":[],"target":["spike protein"],"notes":"Please contact us for further information.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2678","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"120","notes":"This assay detects the SARS-CoV-2 target RdRP and important SARS-CoV-2 mutations on the spike gene (K417T, K417N, E484Q, P681R)","performances":[{"parameter":"Positive control","info":"C+ provided with the kit"}]}]},{"id_device":"2880","commercial_name":"FluoroType\u00ae SARS-CoV-2 plus","manufacturer":{"id_manufacturer":"1279","name":"Hain Lifescience a Bruker company","country":"Germany","website":"https:\/\/www.bruker.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other","Semi-automated"],"target_type":["Nucleic acid"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["Coronaviruses (HCoV)","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","SARS-CoV"],"lineage":[],"target":["Unknown"],"notes":"\tThe test targets two independent genes of the SARS-CoV-2 genome, while simultaneously allowing for the differentiation of non-SARS-CoV-2 patients by detecting four endemic human coronaviruses (HCoVs). The performance characteristics of FluoroType\u00ae SARS-CoV-2 plus is unaffected by the mutations of SARS-CoV-2 strain B.1.1.7 as well as the B.1.351 strain (in silico analysis). Please contact us for further information.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2585","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"120","performances":[{"parameter":"LOD","info":"Depending on the validated extraction methode 1.2 or 8.4 cpu for SARS-CoV-2"},{"parameter":"Positive control","info":"A positive control sample is included in the kit"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"96","unit":"%"}]}]},{"id_device":"2970","commercial_name":"FluoroType\u00ae SARS-CoV-2 varID Q","manufacturer":{"id_manufacturer":"1279","name":"Hain Lifescience a Bruker company","country":"Germany","website":"https:\/\/www.bruker.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Semi-automated"],"target_type":null,"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[],"target":[],"notes":"Targets: RdRp gene, N gene and S gene mutations ( N501Y, del69-70, D80A, E484K). 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Please contact us for further information.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2676","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Quantitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"120","performances":[{"parameter":"Positive control","info":"C+ provided with the kit"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2971","commercial_name":"FluoroType\u00ae SARS-CoV-2\/Flu\/RSV","manufacturer":{"id_manufacturer":"1279","name":"Hain Lifescience a Bruker company","country":"Germany","website":"https:\/\/www.bruker.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Semi-automated"],"target_type":null,"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":["SARS-CoV","Influenza A H1N1","Influenza A H3N2","Influenza B Victoria","Influenza B Yamagata","Respiratory Syncytial V (RSV) Type A","Respiratory Syncytial V (RSV) Type B"],"lineage":[],"target":[],"notes":"The assay was analyzed with 30 bacterial and viral strains potentially present in the nasopharynx or representing common respiratory pathogens. No unintended cross-reactivity was detected. Targets: Flu A Subtypes H1N1 and H3N2, Flu B Lineages Victoria and Yamagata, RSV RSV-A and RSV-B, SARS-CoV-2. The performance characteristics of FluoroType\u00ae SARS-CoV-2\/Flu\/RSV is unaffected by the mutations of SARS-CoV-2 strain B.1.1.7 as well as the B.1.351 strain (in silico analysis). Please contact us for further information.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2677","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"120","performances":[{"parameter":"Positive control","info":"A positive control sample is included in the kit"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"3005","commercial_name":"COVID-19 Antigen Rapid Test Device","manufacturer":{"id_manufacturer":"1331","name":"Hangzhou Aichek Medical Technology Co. 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This test is designed for home use1 with self-collected saliva  samples from symptomatic individuals who are suspected of being infected with  SARS-CoV-2.\r\nThe SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) obtain a preliminary results only, the final confirmation should be based on clinical diagnosis results.","last_updated":"2022-09-29 09:36:38 CET","testList":[{"id_test":"3892","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"99","unit":"%"},{"parameter":"Analytical Specificity","value":"99.7","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.01","unit":"%"},{"parameter":"False negatives","value":"0.003","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.6","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%"}]}]},{"id_device":"208","commercial_name":"2019-nCoV IgG\/IgM Rapid Test Cassette","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. 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Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"  http:\/\/www.alltests.com.cn\/EN\/Prodetail.asp?newsid=1788&cclassid=2&classid=51","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1152","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"False positives","value":"2","unit":"% IgG","info":"5.4% IgG (M.pneumoniae)"},{"parameter":"False negatives","value":"0","unit":"%","info":"7.8% IgG (M.pneumoniae)"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG","info":"+ (Mycoplasma pneumoniae= 92.2% IgG )"},{"parameter":"Clinical Specificity","value":"98.6","unit":"% IgG","info":"+ (Mycoplasma pneumoniae = 93.7% IgG )"}]}]},{"id_device":"1385","commercial_name":"COVID-19 and M.pneumoniae IgG\/IgM Combo","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. 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Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The COVID-19 Antigen Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2091","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.036","unit":"AU"},{"parameter":"False negatives","value":"0.008","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1947","commercial_name":"COVID-19 Antigen Rapid Test (Oral Fluid)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. 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Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1623","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.007","unit":"AU"},{"parameter":"False negatives","value":"0.0099","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2159","commercial_name":"COVID-19 Antigen Rapid Test (Oral Fluid) SELFTESTING","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. 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This test is designed for home use with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19. The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary results only, the final confirmation should be based on clinical diagnostic results.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1860","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.099","unit":"%"},{"parameter":"False negatives","value":"0.007","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%","info":"(Antigen\uff09"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.1","unit":"%","info":"(Antigen\uff09"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%","info":"(Antigen\uff09"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2402","commercial_name":"COVID-19 Antigen Rapid Test (Swab)(NP)","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. 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Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2104","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.036","unit":"AU"},{"parameter":"False negatives","value":"0.01","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1254","commercial_name":"COVID-19 Antigen Test cassette (FIA)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1030","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Fluorescence","subcategory":null,"time_minutes":"15","notes":"FIA method","performances":[]}]},{"id_device":"2302","commercial_name":"COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","MERS-CoV","Influenza A H1N1","Influenza A H3N2","Influenza B","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"The COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) is based on fluorescence immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2003","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.0357","unit":"AU"},{"parameter":"False negatives","value":"0.0071","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.53","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.43","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99.29","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1383","commercial_name":"COVID-19 IgG Rapid Test (cassette)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. 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Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1150","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.7","unit":"%"},{"parameter":"False negatives","value":"5.7","unit":"%"},{"parameter":"Accuracy","value":"96","unit":"% IgG"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"94.3","unit":"% IgG"}]}]},{"id_device":"1381","commercial_name":"COVID-19 IgG\/IgM Rapid Test","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1147","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","notes":"Rapid diagnostic test Strip  ","performances":[{"parameter":"LOD","value":"0"},{"parameter":"False positives","value":"5","unit":"%"},{"parameter":"False negatives","value":"5.6","unit":"%"},{"parameter":"Accuracy","value":"94.9","unit":"%"},{"parameter":"Clinical Sensitivity","value":"94.4","unit":"%"}]}]},{"id_device":"1377","commercial_name":"COVID-19 IgG\/IgM Rapid Test Cassette","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"  similar to  208 (name a bit different but in website : 2019-nCoV IgG\/IgM Rapid Test Cassette)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1142","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","notes":"Rapid diagnostic test lateral flow  ","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"False positives","value":"5","unit":"%"},{"parameter":"False negatives","value":"5.6","unit":"%"},{"parameter":"Accuracy","value":"94.9","unit":"%"},{"parameter":"Clinical Sensitivity","value":"94.4","unit":"%"}]}]},{"id_device":"1382","commercial_name":"COVID-19 IgG\/IgM Rapid Test Dipstick","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"  similar to 674 but name a bit different (on website same as 674: 2019-nCoV IgG\/IgM Rapid Test Dipstick)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1148","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"False positives","value":"2","unit":"% IgG"},{"parameter":"False positives","value":"3","unit":"% IgM"},{"parameter":"False negatives","value":"0.1","unit":"% IgG","info":"<0.1% "},{"parameter":"False negatives","value":"9.1","unit":"% IgM"},{"parameter":"Accuracy","value":"98.4","unit":"% IgG"},{"parameter":"Accuracy","value":"95.9","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"99.9","unit":"% IgG","info":">99.9"},{"parameter":"Clinical Sensitivity","value":"90.9","unit":"% IgM"}]}]},{"id_device":"2416","commercial_name":"COVID-19 IgG\/IgM Test Cassette (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The COVID-19 IgG\/IgM Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.The COVID-19 IgG\/IgM Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 IgG\/IgM Test should not be used as the sole basis for diagnosis. Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV- 2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG\/IgM Test early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2118","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.033","unit":"AU"},{"parameter":"False negatives","value":"0.031","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.9","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.7","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Clinical Specificity","value":"96.9","unit":"%","info":"(IgG\/IgM)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2327","commercial_name":"COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. 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Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2869","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.006","unit":"AU"},{"parameter":"False negatives","value":"0.001","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.6","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.4","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%","info":"(Antigen\uff09"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2325","commercial_name":"GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Additional pathogens tested for cross-reactivity: Human Rhinovirus 14\uff0cHuman Rhinovirus 16\uff0cHuman Rhinovirus 2, Measles, Mumps.   The SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3673","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"The current VOC including Alpha, Beta, Gamma, Delta, Omicron and Omicron BA.2 which will not influence the performance of the Test.","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.026","unit":"AU"},{"parameter":"False negatives","value":"0.001","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2690","commercial_name":"GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) for self testing","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen. The test is intended for use in symptomatic individuals meeting the case definition for COVID-19, and to test asymptomatic individuals limited to contacts of confirmed COVID-19 cases or probable cases and to at-risk health workers. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2395","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"pathogens other: Human Rhinovirus 2 \/ Human Rhinovirus 14 \/ Human Rhinovirus 16 \/ Measles \/ Mumps","performances":[{"parameter":"LOD","value":"100","unit":"%"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.046","unit":"AU"},{"parameter":"False negatives","value":"0.006","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.8","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.4","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3003","commercial_name":"One Step SARS-CoV-2(COVID-19) Antigen Rapid Test (Oral Fluid)","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The One Step SARS-COV-2 (COVID-19) Antigen Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2709","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"%"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.01","unit":"AU"},{"parameter":"False negatives","value":"0.003","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.6","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1258","commercial_name":"SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)","SARS-CoV"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A and Influenza B virus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2\/Influenza infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein and Influenza A+B Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2\/ Influenza A+B.","last_updated":"2022-09-20 17:19:37 CET","testList":[{"id_test":"20281","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU","info":"Evaluated"},{"parameter":"False positives","value":"0.003","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"False positives","value":"0.018","unit":"%","info":"Influenza A+B Test"},{"parameter":"False negatives","value":"0.024","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"False negatives","value":"0.053","unit":"%","info":"Influenza A+B Test"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"Accuracy","value":"97.7","unit":"%","info":"Influenza A+B Test"},{"parameter":"Clinical Sensitivity","value":"97.6","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"Clinical Sensitivity","value":"94.7","unit":"%","info":"Influenza A+B Test"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"Clinical Specificity","value":"98.2","unit":"%","info":"Influenza A+B Test"}]}]},{"id_device":"1257","commercial_name":"SARS-CoV-2 Antigen Rapid Test (COVID-19 Antigen Rapid Test) (Swab)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-09-20 17:20:58 CET","testList":[{"id_test":"3842","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU","info":"Evaluated"},{"parameter":"False positives","value":"0.003","unit":"%","info":"Nasopharyngeal swab(Antigen)"},{"parameter":"False positives","value":"0.001","unit":"%","info":"Nasal swab(Antigen)"},{"parameter":"False negatives","value":"0.0024","unit":"%","info":"Nasopharyngeal swab(Antigen)"},{"parameter":"False negatives","value":"0.026","unit":"%","info":"Nasal swab(Antigen)"},{"parameter":"Accuracy","value":"99","unit":"%","info":"Nasopharyngeal swab(Antigen)"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"Nasal swab(Antigen)"},{"parameter":"Clinical Sensitivity","value":"97.6","unit":"%","info":"Nasopharyngeal swab(Antigen)"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%","info":"Nasal swab(Antigen)"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"Nasopharyngeal swab(Antigen)"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%","info":"Nasal swab(Antigen)"}]}]},{"id_device":"2257","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Nasal Swab)","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasal swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1958","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.026","unit":"%"},{"parameter":"False negatives","value":"0.001","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2529","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Nasal Swab) for self testing","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2Antigen Rapid Test(Nasal Swab)is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen from symptomatic individuals who are suspected of being infected with COVID-19. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens.An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive resultsare indicative of thepresence of SARS-CoV-2. ndividuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacteria infection or co-infection with other viruses. Negative results do not precludeSARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.","last_updated":"2022-10-12 09:39:01 CET","testList":[{"id_test":"3963","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.028","unit":"%"},{"parameter":"False negatives","value":"0.005","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.6","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.2","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1946","commercial_name":"SARS-COV-2 rapid antigen test (Swab)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1622","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.006","unit":"AU"},{"parameter":"False negatives","value":"0.066","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1368","commercial_name":"SARS-COV-2 RT-qPCR Assay","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1136","assay_category":"Nucleic acid-PCR","rapid_diagnostic":"No","self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"100","performances":[{"parameter":"LOD","value":"200","unit":"copies\/ml"},{"parameter":"Positive control","info":"RAN Pseudovirus"},{"parameter":"Negative control","info":"DEPC-Treated Water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"99.14","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"99.14","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"2403","commercial_name":"SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood\/Serum\/ Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD). Positive results indicate the presence of antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2105","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.022","unit":"AU"},{"parameter":"False negatives","value":"0.015","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%","info":"(Antibody)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.8","unit":"%","info":"(Antibody)"},{"parameter":"Clinical Specificity","value":"98.5","unit":"%","info":"(Antibody)"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2404","commercial_name":"SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"1003","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood\/Serum\/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2106","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.022","unit":"AU"},{"parameter":"False negatives","value":"0.015","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.8","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"98.5","unit":"% IgG"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2390","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.com.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Mumps Virus (MuV)","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus(RSV) antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2\/Influenza\/RSV infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2, Influenza A+B and RSV Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/Influenza A+B\/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B and RSV. The SARS-CoV-2\/Influenza A+B\/RSV Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2023-01-09 10:04:20 CET","testList":[{"id_test":"20279","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"97","unit":"%","info":"(Antigen)\uff08SARS-CoV-2 Test\uff09"},{"parameter":"Analytical Specificity","value":"99","unit":"%","info":"(Antigen)\uff08SARS-CoV-2 Test\uff09"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.057","unit":"AU","info":"(RSV Test)"},{"parameter":"False negatives","value":"0.038","unit":"AU","info":"(RSV Test)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.9","unit":"%","info":"(Antigen)(RSV Test)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.9","unit":"%","info":"(Antigen) (Influenza B test)"},{"parameter":"Clinical Specificity","value":"96.2","unit":"%","info":"(Antigen)(RSV Test)"}]}]},{"id_device":"2392","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. 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Results are for the detection of SARS-CoV-2, Influenza A+B, RSV and Adenovirus antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B\/RSV\/Adenovirus infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B ,RSV and Adenovirus. The SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2023-01-09 10:05:07 CET","testList":[{"id_test":"20280","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"96.4","unit":"%","info":"(Antigen) (SARS-CoV-2 Test)"},{"parameter":"Analytical Specificity","value":"99","unit":"%","info":"(Antigen) (SARS-CoV-2 Test)"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.088","unit":"AU","info":"(Adenovirus)"},{"parameter":"False negatives","value":"0.014","unit":"AU","info":"(Adenovirus)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%","info":"(Antigen)(Influenza B test)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.9","unit":"%","info":"(Antigen)(Adenovirus Test)"},{"parameter":"Clinical Specificity","value":"98.6","unit":"%","info":"(Antigen)(Adenovirus Test)"}]}]},{"id_device":"2396","commercial_name":"SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. 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Results are for the detection of SARS-CoV-2, Influenza A+B, RSV, Adenovirus and M.pneumoniae antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of correlative antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial\/viral infection. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2, Influenza A+B,RSV , Adenovirus and M.pneumoniae. The SARS-CoV-2\/Influenza A+B\/RSV\/Adenovirus\/M.pneumoniae Antigen Combo Rapid Test is intended for use by trained clinical laboratory personnel.","last_updated":"2023-01-09 10:05:47 CET","testList":[{"id_test":"5417","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"96.4","unit":"%","info":"(Antigen)\uff08SARS-CoV-2 Test\uff09"},{"parameter":"Analytical Specificity","value":"99","unit":"%","info":"(Antigen)\uff08SARS-CoV-2 Test\uff09"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.082","unit":"AU","info":"(M.pneumoniae)"},{"parameter":"False negatives","value":"0.02","unit":"AU","info":"(M.pneumoniae\uff09"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.9","unit":"%","info":"(Antigen)(RSV Test)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.8","unit":"%","info":"\uff08Antigen\uff09\uff08M.pneumoniae)\uff09"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":"(Antigen)(M.pneumoniae)"}]}]},{"id_device":"210","commercial_name":"LAMP kit for qualitative detection of SARS-CoV-2","manufacturer":{"id_manufacturer":"127","name":"Hangzhou Bigfish Bio-tech Co. 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Ltd.","country":"China","website":"www.bigfishgene.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"1. Store at 4~30\u2103 out of direct sunlight, and it is valid for 24 months from Production Date. 2. Keep dry, and do not use frozen and expired devices. 3. Test cassette should be used within half 1 hour once opening the Aluminum foil pouch. 4. Store the buffer at 4~30\u2103, and it should be use within 3 months after opening.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2602","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"30","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"99.25","unit":"%"},{"parameter":"False positives","value":"98.94","unit":"%"},{"parameter":"False positives","value":"99.64","unit":"%"},{"parameter":"False negatives","value":"95.08","unit":"%","info":"In the clinical study, the PPA for three swabs are "},{"parameter":"False negatives","value":"94.58","unit":"%","info":"In the clinical study, the PPA for three swabs are 95.08%, 94.58% and 93.81%."},{"parameter":"False negatives","value":"93.81","unit":"%","info":"In the clinical study, the PPA for three swabs are 95.08%, 94.58% and 93.81%."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.32","unit":"%","info":"Antigen, Oropharyngeal Swab"},{"parameter":"Accuracy","value":"97.55","unit":"%","info":"Antigen, Nasopharyngeal Swab"},{"parameter":"Accuracy","value":"97.26","unit":"%","info":"Antigen, Anterior Nasal swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.86","unit":"%","info":"Antigen, Nasopharyngeal Swab"},{"parameter":"Clinical Sensitivity","value":"98.13","unit":"%","info":"Antigen, Oropharyngeal Swab"},{"parameter":"Clinical Sensitivity","value":"99.45","unit":"%","info":"Antigen, Anterior Nasal swab"},{"parameter":"Clinical Specificity","value":"96.7","unit":"%","info":"Antigen, Nasopharyngeal Swab"},{"parameter":"Clinical Specificity","value":"96.88","unit":"%","info":"Antigen, Oropharyngeal Swab"},{"parameter":"Clinical Specificity","value":"95.88","unit":"%","info":"Antigen, Anterior Nasal swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"211","commercial_name":"The golden standard of SARS-CoV-2 viral nucleic acid detection","manufacturer":{"id_manufacturer":"127","name":"Hangzhou Bigfish Bio-tech Co. 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Ltd.","country":"China","website":"sejoy.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":["nucleocapsid protein"],"notes":"We have also evaluated interference substance as following:Whole Blood,Ibuprofen,Tetracycline,Mucin,Erythromycin,Tobramycin,Menthol,Afrin, Compound Benzoin Gel,Cromolyn glycate , Chloramphenicol ,Mupirocin,Oseltamivir,Naphazoline Hydrochlo-ride Nasal Drops,Fluticasone propionate spray,Deoxyepinephrine hydro-chloride","last_updated":"2023-03-02 11:30:05 CET","testList":[{"id_test":"21058","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Other","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"87","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%"},{"parameter":"False negatives","value":"13","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.79","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"87","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1952","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva)","manufacturer":{"id_manufacturer":"887","name":"Hangzhou Sejoy Electronics & Instruments Co. 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Ltd.","country":"China","website":"www.testsealabs.com\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Antibody"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"805","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"5","performances":[{"parameter":"Accuracy","value":"94","unit":"%"},{"parameter":"Clinical Sensitivity","value":"88","unit":"%"}]}]},{"id_device":"4108","commercial_name":"SARS-CoV-2 Antigen Test(Nasal swab)","manufacturer":{"id_manufacturer":"1468","name":"Hangzhou Tongzhou Biotechnology Co Ltd","country":"China","website":""},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab specimens.\r\nResults are for the identification of SARS-CoV-2 nucleocapsid protein antigen.  Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to \r\ndetermine infection status. Positive results do not rule out bacterial infection or co\u0002infection with other viruses. The agent detected may not be the definite cause of disease.\r\nNegative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions including infection control decisions. \r\nNegative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.Individuals who test negative and continue to experience COVID-like symptoms \r\nshould seek follow up care from their healthcare provider.","last_updated":"2022-09-29 09:37:02 CET","testList":[{"id_test":"3893","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"%"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"97","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.03","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"24766","commercial_name":"SARS-CoV-2 Antigen Test\uff08nasopharyngeal swab\uff09","manufacturer":{"id_manufacturer":"17328","name":"Hangzhou Tongzhou Biotechnology Co Ltd","country":"China","website":"www.tongzhoubio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza A H5N1","Influenza B","MERS-CoV","Mumps Virus (MuV)","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasopharyngeal swab specimens.\r\nResults are for the identification of SARS-CoV-2 nucleocapsid protein antigen. \r\nAntigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co\u0002infection with other viruses. The agent detected may not be the definite cause of \r\ndisease.\r\nNegative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions including infection control decisions. \r\nNegative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.\r\nIndividuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.","last_updated":"2023-07-27 10:46:07 CET","testList":[{"id_test":"21091","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"N.A.","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Analytical Specificity","value":"99.3","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.066","unit":"AU"},{"parameter":"False negatives","value":"0.007","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"}]}]},{"id_device":"2942","commercial_name":"SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette (Swab)","manufacturer":{"id_manufacturer":"1298","name":"Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd.","country":"China","website":"https:\/\/www.zdbiogene.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"none","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2648","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"4.86","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.07","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.14","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1230","commercial_name":"Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit","manufacturer":{"id_manufacturer":"627","name":"Hayat Genetics Inc.","country":"Turkey","website":"www.hayatgenetics.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test is an isothermal nucleic acid amplification method intended for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal and nasopharyngeal swabs) and saliva collected from individuals suspected of COVID-19 by their healthcare provider. Testing is intended to be carried out in a clinical laboratory setting  https:\/\/www.hayatgenetics.com\/additional-info","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1014","assay_category":"Nucleic acid-Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"LAMP","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"30","notes":" Information provided by manufacturer: Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test is an isothermal nucleic acid amplification method intended for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal and nasopharyngeal swabs) and saliva collected from individuals suspected of COVID-19 by their healthcare provider. Testing is intended to be carried out in a clinical laboratory setting","performances":[{"parameter":"LOD","value":"5","unit":"cpr"},{"parameter":"Positive control","info":"Synthetic SARS-CoV-2 DNA"},{"parameter":"Negative control","info":"Nuclease Free Water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Throughput","info":"96 samples per run"}]}]},{"id_device":"2362","commercial_name":"CLINITEST\u00ae Rapid COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"1092","name":"Healgen","country":"United States","website":"healgen.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":[],"notes":"The RAT is already registered at https:\/\/covid-19-diagnostics.jrc.ec.europa.eu\/devices\/detail\/1767 - however with another name. To be able of using the RAT in Switzerland as an aid for the COVID-Certificate i was told it needs to have the exact same name. As the RAT with ID 1767 doesn't have the same name, eventhough it's the same test, herbey the application. If it is possible to add the name to 1767 it will work for Switzerland as well, I guess. Otherwise it needs to be added. Thank you and best regards Kristian Palas","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2063","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1.15","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"sensitivity: 98.32% specificity: 99.6%"},{"parameter":"False negatives","info":"sensitivity: 98.32% specificity: 99.6%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.73","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2238","commercial_name":"Clinitest Rapid Covid-19 Antigen Self Test","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"n\/a","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1939","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"115"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"97.25% Sensitivity, 100% Specificity"},{"parameter":"False negatives","info":"97.25% Sensitivity, 100% Specificity"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98.73","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.25","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2737","commercial_name":"CLINITEST\u00ae Rapid COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Rationale: Updating already-existing listing to correct the manufacturer and antigen type","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2442","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Accuracy","value":"99.42","unit":"%","info":"nasopharyngeal swab"},{"parameter":"Accuracy","value":"98.73","unit":"%","info":"nasal swab"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%","info":"nasopharyngeal swab"},{"parameter":"Clinical Sensitivity","value":"97.25","unit":"%","info":"nasal swab"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":"nasopharyngeal swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"nasal swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1767","commercial_name":"Coronavirus Ag Rapid Test Cassette","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1446","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Accuracy","value":"98.73","unit":"%","info":"Nasal swab"},{"parameter":"Accuracy","value":"99.42","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Sensitivity","value":"97.25","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":"Nasopharyngeal swab"}]}]},{"id_device":"677","commercial_name":"COVID-19 IgG\/IgM Rapid Test Cassette (Whole Blood\/Serum\/Plasma)","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"806","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[]}]},{"id_device":"1735","commercial_name":"Rapid COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Other"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1414","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"115","unit":"U\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.35","unit":"%","info":"3 of 865"},{"parameter":"False negatives","value":"0.23","unit":"%","info":"2 of 865"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"99.42","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1612","commercial_name":"Rapid COVID-19 AntigenTest","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1796","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"CLIA","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"2974","commercial_name":"Healfo SARS-CoV-2 Ag Saliva Rapid Test","manufacturer":{"id_manufacturer":"1313","name":"Healvet Medtech GZ 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False negative results can occur if the saliva is not collected properly. 2. Do not eat or drink any things for 2 hours before the test.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2680","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"For in vitro diagnostic use."},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.85"},{"parameter":"False negatives","value":"6.6"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.3"},{"parameter":"Clinical Specificity","value":"99.1"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"478","commercial_name":"COVID-19 IgM Antibody Rapid Test Kit","manufacturer":{"id_manufacturer":"303","name":"Hecin Scientific Inc.","country":"China","website":"www.hecin-scientific.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgM"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"400","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"1637","commercial_name":"SARS-CoV-2 IgM\/IgG Antibody Test Kit (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"733","name":"Hefei Biohit Healthcare","country":"China","website":"www.biouhan.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":["Anti-Nuclear Antibody","Hemophilus Influenzae","Hepatitis B Virus (HBV)","Hepatitis C Virus (HCV)","Influenza A","Influenza B","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein","spike protein"],"notes":"The SARS-CoV-2 IgM\/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, K2-EDTA, and sodium citrate), and whole blood (heparin, K2-EDTA, sodium citrate, and no anticoagulant).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1317","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"14","performances":[{"parameter":"LOD","value":"10","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.4","unit":"% IgG"},{"parameter":"Accuracy","value":"99.1","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.66","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"99.46","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"98.66","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2946","commercial_name":"UDXBIO","manufacturer":{"id_manufacturer":"1299","name":"Henan UDX Biotechnology Co. 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CET","testList":[{"id_test":"2652","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"n=363"},{"parameter":"False negatives","value":"7.62","unit":"%","info":"n=105"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.29","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.38","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1958","commercial_name":"Covid-19 Slide Test","manufacturer":{"id_manufacturer":"896","name":"HGH Desinfections und Cosmetique GmbH","country":"Austria","website":"www.hgh-group.at\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"Detects SARS-CoV-2 S antigen and SARS-CoV-2 N antigen","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1634","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Other","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1.25","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False 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CET","testList":[{"id_test":"172","assay_category":"Nucleic acid-Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"LAMP","measurement":null,"subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2739","commercial_name":"PCR Adapt 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09:22:17 CET","testList":[{"id_test":"2444","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2628","commercial_name":"SARS-CoV-2 Antigen Test Kit (Colloidal Gold) - Saliva","manufacturer":{"id_manufacturer":"1199","name":"Hipro Biotechnology Co. Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"SARS-CoV-2 Antigen Test Kit (saliva\uff09(Colloidal Gold) can quickly detect SARS-CoV-2 antigen in saliva by forming visible lines and provide auxiliary diagnosis for Covid-19 infection","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2333","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"130","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.66","unit":"%","info":"10\/600"},{"parameter":"False negatives","value":"1.87","unit":"%","info":"5\/267"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98.27","unit":"%","info":" (95%CI: 97,46%-99,08%)"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98.6","unit":"%","info":" (95%CI: 96,04%-99,24%)"},{"parameter":"Clinical Specificity","value":"97","unit":"%","info":" (95%CI: 96,62%-99,84%)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"972","commercial_name":"Aptima SARS-CoV-2 Assay (Panther System)","manufacturer":{"id_manufacturer":"133","name":"Hologic","country":"United States","website":"www.hologic.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"760","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"140","notes":" https:\/\/www2.hologic.com\/pantherfusion-sars-cov-2#","performances":[]}]},{"id_device":"217","commercial_name":"Panther Fusion SARS-CoV-2 assay","manufacturer":{"id_manufacturer":"133","name":"Hologic","country":"United States","website":"www.hologic.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"173","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"https:\/\/www.hologic.com\/package-inserts\/diagnostic-products\/panther-fusionr-sars-cov-2-assay","performances":[]}]},{"id_device":"218","commercial_name":"On-site rapid molecular diagnostic system based on Shenzhen Shineway Technology","manufacturer":{"id_manufacturer":"134","name":"Hong Kong University of Science and Technology","country":"Hong Kong S.A.R","website":"www.ust.hk\/news\/research-and-innovation\/www.ust.hk"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"174","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"40","notes":" https:\/\/www.ust.hk\/news\/research-and-innovation\/hkust-research-team-invents-worlds-fastest-coronavirus-detection","performances":[]}]},{"id_device":"1929","commercial_name":"Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"883","name":"Hoyotek Biomedical Co. Ltd.","country":"China","website":"http:\/\/hoyotek.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Influenza A","Influenza A H3N2","Influenza B","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Rhinovirus"],"lineage":[{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein","Other"],"notes":"The nasal swab model of the product has been evaluated by Braizil lab and Thai RAMA Hospital. For Braizil lab: Sensitivity 97.1%, For RAMA hospital Sensitivity 95%, specificity 100%","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1605","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"13","notes":"antigen_epi: 45-181aa. Other pathogens tested for cross-reactivity: MERS-coronavirus,Adenovirus 71,Human Metapneumovirus,Enterovirus,RStreptococcus pneumoniae,espiratory syncytial virus A,Rhinovirus,Haemophilus influenza,Streptococcus pneumoniae","performances":[{"parameter":"LOD","value":"200","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"Nasopharyngeal swab\/Antigen"},{"parameter":"False positives","value":"2.5","unit":"%","info":"Oropharyngea swab\/Antigen"},{"parameter":"False positives","value":"5.45","unit":"%","info":"Nasal swab"},{"parameter":"False negatives","value":"4","unit":"%","info":"Nasopharyngeal swab\/Antigen"},{"parameter":"False negatives","value":"7","unit":"%","info":"Oropharyngea swab\/Antigen"},{"parameter":"False negatives","value":"0.21","unit":"%","info":"Nasal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"Nasopharyngeal swab\/Antigen"},{"parameter":"Accuracy","value":"98.79","unit":"%","info":"Nasal swab"},{"parameter":"Accuracy","value":"94.8","unit":"%","info":"Oropharyngea swab\/Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%","info":"Oropharyngea swab"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Sensitivity","value":"94.55","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Specificity","value":"97.5","unit":"%","info":"Oropharyngea swab"},{"parameter":"Clinical Specificity","value":"99.79","unit":"%","info":"Nasal swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein, Other"}]}]},{"id_device":"1930","commercial_name":"Corona Virus (COVID-19) Combined (IgM\/IgG\/Neutralizing antibody) Rapid Test (Colloidal gold)","manufacturer":{"id_manufacturer":"883","name":"Hoyotek Biomedical Co. Ltd.","country":"China","website":"http:\/\/hoyotek.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"This kit consists of test card 1 and test card 2. Test card 1 adopts the principle of colloidal gold immunochromatographic sandwich method to detect the novel Corona Virus (COVID-19) IgM \/ IgG antibody. When a positive sample is added to the sample well\uff0cCOVID-19 Antibodies (IgM\/IgG) in the sample will be combined with colloidal gold labeled COVID-19 RBD recombinant protein and form into immune complexes\u3002When reaching Test Zone, the complexes will be combined with mouse anti-human IgM monoclonal antibody and mouse anti-human IgG monoclonal antibody. M line and G line occur red color. When testing negative samples, there\u2019s no COVID-19 IgM or IgG in the samples, no immune complexes will be formed and color only appears in the Control line. Test card 2 adopts the principle of colloidal gold immunochromatographic competition method to detect Neutralizing antibody. When testing negative samples, colloidal gold labeled ACE2 protein will be combined with COVID-19 RBD recombinant protein which coated on test line and the detection line develops color. When a positive sample is added to the sample well, COVID-19 Neutralizing antibody in the sample mix with colloidal gold labeled ACE2 protein, and does not bind to COVID-19 RBD recombinant protein. The intensity of T line color is) less than C line.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1606","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Capture","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","notes":"Neutralizing antibody","performances":[{"parameter":"LOD","value":"0.5","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1931","commercial_name":"Influenza A\/B\/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"883","name":"Hoyotek Biomedical Co. Ltd.","country":"China","website":"http:\/\/hoyotek.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[],"target":["Other"],"notes":"The product is based on the principle of sandwich and colloidal gold immunochromatography, the nitrocellulose membrane Test Zone is pre-coated with mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody, the Control Zone is pre-coated with goat anti-mouse polyclonal antibody, the gold conjugation pad is pre-coated with colloidal gold labeled mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody. When testing positive samples, Influenza A\/B\/COVID-19 Antigen the sample will be combined with colloidal gold (Au) labeled mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody and form into immune complexes (Au-mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody-[ Influenza A\/B\/COVID-19- (Antigen)]), the complexes will move forward inside the nitrocellulose membrane by chromatography effect. When reaching Test Zone, the complexes will be combined with mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody, and form into \u201c(Au-mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody-[COVID-19- (Antigen)])-[ mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody]\u201d, thus agglutination color appears; The residual colloidal gold labeled mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody will be combined with goat anti-mouse polyclonal antibody at the Control Zone, and produce color under agglutination. When testing negative samples, there\u2019s no Influenza A\/B\/COVID-19 Antigen in the samples, no immune complexes will be formed and color only appears in the Control line.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1607","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"5.25","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"COVID-19"},{"parameter":"False positives","value":"1.5","unit":"%","info":"FluB"},{"parameter":"False positives","value":"2","unit":"%","info":"FluA"},{"parameter":"False negatives","value":"4","unit":"%","info":"COVID-19"},{"parameter":"False negatives","value":"8","unit":"%","info":"FluB"},{"parameter":"False negatives","value":"6","unit":"%","info":"FluA"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.5","unit":"%","info":"FluA"},{"parameter":"Accuracy","value":"95.3","unit":"%","info":"FluB"},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"COVID-19"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%","info":"FluA"},{"parameter":"Clinical Sensitivity","value":"92.1","unit":"%","info":"FluB"},{"parameter":"Clinical Sensitivity","value":"96","info":"COVID-19"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":"FluA"},{"parameter":"Clinical Specificity","value":"98.5","unit":"%","info":"FluB"},{"parameter":"Clinical Specificity","value":"99","info":"COVID-19"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"3562","commercial_name":"Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) - self-testing","manufacturer":{"id_manufacturer":"1418","name":"Hoyotek Biomedical Co.,Ltd,","country":"China","website":"http:\/\/hoyotek.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Influenza A","Influenza A H3N2","Influenza B","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Rhinovirus"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3280","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"13","performances":[]}]},{"id_device":"1748","commercial_name":"2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25","manufacturer":{"id_manufacturer":"780","name":"Huachenyang (Shenzhen) Technology Co. 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Ltd.","country":"China","website":"https:\/\/www.chenyanglobal.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Lab-based","Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein","Other"],"notes":"variants_detected BA.1, BA.2","last_updated":"2022-10-17 12:54:53 CET","testList":[{"id_test":"5205","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"9","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.36","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"91","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2527","commercial_name":"COVID-19 lgM\/lgG Antibody Diagnostic Kit(Colloidal Gold)","manufacturer":{"id_manufacturer":"780","name":"Huachenyang (Shenzhen) Technology Co. 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Ltd.","country":"South Korea","website":"http:\/\/www.humasis.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["Other"],"notes":"Celltrion DiaTrustTM COVID-19 Ag Rapid Test is designed for qualitative detection of SARS-CoV-2 antigens in nasopharyngeal and nasal swab specimen of symptomatic patients suspected of COVID-19 [ MATERIAL COMPOSITION ] \u25cf Monoclonal antibody to SARS-CoV-2 Nucleocapsid \u25cf Monoclonal antibody specific to RBD of SARS-CoV-2 Spike Protein \u25cf Goat anti-mouse IgG Celltrion DiaTrust COVID-19 Ag Rapid Test: Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use. EUA Number: EUA210190","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2340","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"32","unit":"TCID50\/ml","info":"5 x 100.8 TCID50\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Unknown"},{"parameter":"False negatives","info":"Unknown"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","info":"Unknown"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"92","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"5719","commercial_name":"Celltrion DiaTrust\u2122 COVID-19 IgG\/IgM Rapid Test","manufacturer":{"id_manufacturer":"1062","name":"Humasis Co. 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CET","testList":[{"id_test":"2450","assay_category":"Immuno-Antibody","rapid_diagnostic":"No","self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Quantitative","subclass":"Enzyme-linked","detection_principle":null,"subcategory":null,"time_minutes":"130","performances":[{"parameter":"LOD","value":"3","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.75","unit":"%","info":"1\/133"},{"parameter":"False negatives","value":"3.63","unit":"%","info":"2\/55"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"76.1","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.2","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.2","unit":"% IgG"},{"parameter":"Type of antigen","info":"Spike 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Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2804","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Other variants detected: Delta-Plus(AY.1), Natural Wild Variant","performances":[{"parameter":"LOD","value":"160","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.91","unit":"%","info":"1 in 110 cases"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 in 470 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.83","unit":"%","info":"95%CI: 99.04%-100.00%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.09","unit":"%","info":"95%CI: 95.04%-99.98%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95%CI: 99.22%-100.00%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"229","commercial_name":"Rapid SARS-CoV-2 Antibody (IgM\/IgG)","manufacturer":{"id_manufacturer":"147","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"190","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"228","commercial_name":"Rapid SARS-CoV-2 Antibody Test","manufacturer":{"id_manufacturer":"147","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"189","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"Rapid diagnostic test Fingertip Not found ","performances":[]}]},{"id_device":"2484","commercial_name":"Rapid SARS-CoV-2 Antigen Test","manufacturer":{"id_manufacturer":"147","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. This test is for self-testing. The test is for self-test with self-collected anterior nasal swab samples. It is indicated for the use of individuals aged 18 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2187","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Other variants detected: Delta-Plus (AY.1), Natural Wild Variant.  Other pathogens tested for cross-reactivity: H7N9 avian influenza virus, Legionella, Streptococcus Pneumoniae, Enterovirus A, Enterovirus B, Staphylococcus aureus","performances":[{"parameter":"LOD","value":"425","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6.36","unit":"%","info":"7 in 110 cases"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 in 470 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.79","unit":"%","info":"95%CI: 97.53%-99.51%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.64","unit":"%","info":"95%CI: 87.33%-97.40%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95%CI: 99.22%-100.00%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2419","commercial_name":"Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen)","manufacturer":{"id_manufacturer":"1107","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"PEI positive evaluated, Test-ID AT574\/21.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2121","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"425","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6.93","unit":"%","info":"7 false positives in 101 samples"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 false negatives in 299 samples"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.3","unit":"%","info":"95% CI: 96.4% - 99.2%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.1","unit":"%","info":"95% CI: 86.4% - 96.6%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI: 98.7% - 100%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1783","commercial_name":"Rapid SARS-CoV-2 Antigen Test (nasopharyngeal\/nasal specimen)","manufacturer":{"id_manufacturer":"1107","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":["Chlamydia Pneumoniae","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","MERS-CoV","Human Metapneumovirus (HMPV)","Influenza A H1N1","Influenza A H3N2","Influenza B Yamagata","Mycobacterium Tuberculosis","Mycoplasma Pneumoniae","Parainfluenza Virus Type 1","Respiratory Syncytial V (RSV) Type A","SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Intended use The Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal\/nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. The test is suitable for use under healthcare professional supervision. Individuals should have appropriate training in how to administer the test correctly.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1462","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"425","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.4","unit":"%","info":"2 in 1026 cases"},{"parameter":"False negatives","value":"4.5","unit":"%","info":"20 in 484 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%","info":"95%CI: 97.8%~99.0%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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Assay","manufacturer":{"id_manufacturer":"434","name":"Integrity Laboratories","country":"United States","website":"integritylaboratories.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"592","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"1882","commercial_name":"MAUVE COVID-19 Ag Test","manufacturer":{"id_manufacturer":"861","name":"InTelos Inc.","country":"South 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CET","testList":[{"id_test":"808","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"480","commercial_name":"LiliF COVID-19 Real-time RT-PCR Kit","manufacturer":{"id_manufacturer":"297","name":"intron biotechnology","country":"South Korea","website":"www.intron.co.kr\/"},"ce_marking":"Yes","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Sputum"],"pathogen":[],"lineage":[],"target":[],"notes":"Cat.number is  IPH21506","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"385","assay_category":"Nucleic 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CET","testList":[{"id_test":"1315","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Accuracy","value":"98","unit":"%"}]}]},{"id_device":"1988","commercial_name":"Biozek covid-19 Antigen Rapidtest BCOV-502","manufacturer":{"id_manufacturer":"910","name":"Inzek International trading","country":"Netherlands","website":"www.biozek.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal 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We have received the following message from the DHSC (Department of Health and social care): product progressed through phase 3A validation and has been examined at a Design Authority Review (DAR). We would like to advise you that the Biozek COVID-19 Antigen Rapid Test Cassette (Swab) was successful in the phase 3A validation and that the Biozek COVID-19 Antigen Rapid Test Cassette (Swab) showed no drop off in sensitivity when compared with the wild type with respect to the following variants - Alpha (VOC1 Kent, UK, B.1.1.7), Beta (VOC2 South Africa, B.1.351), Gamma (VOC3 Brazil, P1) and Delta (VOC4 India B.1.617.2).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1664","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.65","unit":"%","info":"4\/151"},{"parameter":"False negatives","value":"0.67","unit":"%","info":"10\/1484"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.14","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.63","unit":"%"},{"parameter":"Clinical Specificity","value":"99.73","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1987","commercial_name":"Biozek covid-19 Antigen Rapidtest BCOV-802","manufacturer":{"id_manufacturer":"910","name":"Inzek International trading","country":"Netherlands","website":"www.biozek.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"Check IFU for more information. Clinical studies available. 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The analytic sensitivity is 10 copies\/reaction. N1 and N2 genes are amplified using sequence-specific primers and the detection is done using the FAM filter pair. To control PCR inhibition an endogenous internal control is incorporated into the system. 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It provides an end-to-end fully digitalized solution from rapid antigen test, timely result with digital pass issuing and access control by cross-validating test results on the cloud through a suite of digital tools including PixoHealth Pass App, PixoHealth Pass Admin App and Web portal for enterprises to prevent potential outbreaks.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1918","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"125","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"5","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":" (Antigen) Taipei"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"5754","commercial_name":"SARS-COV-2 Antigen Rapid Test Kit","manufacturer":{"id_manufacturer":"3208","name":"Jiangsu Baozhilin Medical Co Ltd","country":"China","website":""},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"last_updated":"2022-11-07 14:09:56 CET","testList":[{"id_test":"5287","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"samples"},{"parameter":"False negatives","value":"2","unit":"samples"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"99.61","unit":"%"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98.2","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2821","commercial_name":"SARS-COV-2 Antigen Rapid Test Kit ","manufacturer":{"id_manufacturer":"1260","name":"Jiangsu Baozhilin Medical Technology Co. 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The test is intended for detection of neutralization antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in whole blood, serum or plasma specimen from the population vaccinated with SARS-CoV-2 vaccine.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2042","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.69","unit":"%"},{"parameter":"False negatives","value":"0.87","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.31","unit":"%"},{"parameter":"Clinical Specificity","value":"99.13","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2338","commercial_name":"SARS-CoV-2 Neutralization Antibody Test Kit (ELISA)","manufacturer":{"id_manufacturer":"1083","name":"Jiangsu Mole Bioscience Co. 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Ltd.","country":"China","website":"http:\/\/en.molechina.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[],"target":[],"notes":"SARS-CoV-2 Total Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of total antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2040","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"10","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6.31","unit":"%"},{"parameter":"False negatives","value":"1.06","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.69","unit":"%"},{"parameter":"Clinical Specificity","value":"98.94","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2337","commercial_name":"SARS-CoV-2 Total Antibody Test Kit (ELISA)","manufacturer":{"id_manufacturer":"1083","name":"Jiangsu Mole Bioscience Co. Ltd.","country":"China","website":"http:\/\/en.molechina.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Semi-automated"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"notes":"SARS-CoV-2 Total Antibody Test Kit (ELISA) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of IgG, IgM and IgA antibodies to SARS-CoV-2 in human serum or plasma specimen (dipotassium EDTA, lithium heparin and sodium citrate).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2038","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Qualitative","subclass":"Enzyme-linked","detection_principle":null,"subcategory":null,"time_minutes":"120","performances":[{"parameter":"LOD","value":"5","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.6","unit":"%"},{"parameter":"False negatives","value":"1.21","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.21","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%"},{"parameter":"Clinical Specificity","value":"98.79","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"239","commercial_name":"Fluorescent RAA Detection for 2019-nCoV","manufacturer":{"id_manufacturer":"148","name":"Jiangsu Qitian Gene Biotechnology Co. Ltd.","country":"China","website":"qt.test.xjrkj.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"191","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"240","commercial_name":"Fast SARS-CoV-2 lgM\/lgG Antibody Detection Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"152","name":"Jiangsu Superbio Biomedical Technology (Nanjing) Co. Ltd.","country":"China","website":"www.superbio.cn\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"198","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2144","commercial_name":"COVID-19 Ag Rapid Test Device","manufacturer":{"id_manufacturer":"992","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"COVID-19 Ag Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of N antigen to SARS-CoV- 2 present in human nasal swabs. This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient. The result of this test should not be the sole basis for the diagnosis; con\ufb01rmatory testing is required.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1834","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5.26","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.74","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2500","commercial_name":"Orawell COVID-19 Ag Rapid Saliva Test Device (CO-03)","manufacturer":{"id_manufacturer":"1139","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"www.wellbioscience.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"}],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2204","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"60","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False negatives","value":"4.4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.21","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2517","commercial_name":"Orawell COVID-19 Ag Rapid Saliva Test Device (CO-07)","manufacturer":{"id_manufacturer":"1139","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"www.wellbioscience.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"}],"target":[],"notes":"NA","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2221","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"60","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False negatives","value":"3.8","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.48","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.15","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2495","commercial_name":"OraWell COVID-19 Ag.Rapid Saliva test DEVICE, CO-07(One Step)","manufacturer":{"id_manufacturer":"1131","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"https:\/\/www.wellbioscience.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC","Other","Semi-automated"],"target_type":["Antigen"],"specimen":["Other","Saliva","Sputum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Principle The COVID-19 Ag Rapid Saliva Test Device uses double antibody sandwich immunoassay. The NC membrane pre-immobilized with monoclonal antibodies against SARS-CoV-2 antigen and anti-mouse polyclonal antibodies, and the colloidal-gold conjugated with monoclonal antibodies specific to SARS-CoV-2 antigen. If SARS-CoV-2 antigen present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the antigen will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 to 20 minutes in the form of a red line that develops on the strip. Whether the sample contains the SARS-CoV-2 antigen or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C. Kit Content 1) Test device (individually packed in a foil pouch with desiccant). 2) Instruction for use. Materials required but not provided Timer Precautions \u2022 For in vitro diagnostic use only. \u2022 Do not re-use the test device. \u2022 Do not use after the expiration date. \u2022 Do not use the test kit if the pouch is damaged or the seal is broken. \u2022 Perform test at room temperature 15 to 30\u00b0C. \u2022Wear gloves when hanging the samples, avoid touching the reagent membrane and sample window. \u2022 All samples and used accessories should be treated as infectious and discarded according to local regulations. \u2022 Avoid using blood samples.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2198","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"25","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.65","unit":"%","info":"6 on 129"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 on 200"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.21","unit":"%","info":"98,21 %"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2496","commercial_name":"OraWell COVID-19 NEUTRALIZING ANTIBODY Rapid Test Device - CO_04 (Check vaccination coverage)","manufacturer":{"id_manufacturer":"1131","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"https:\/\/www.wellbioscience.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC","Other","Semi-automated"],"target_type":["Antibody","IgG"],"specimen":["Peripheral blood","Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""}],"target":[],"notes":"COVID-19 neutralizing antibody Test is a chromatographic immunoassay for the detection of neutralizing antibodies to COVID-19 in human whole blood, serum and plasma. The test device contains: 1) Colloidal gold-labeled recombinant SARS-CoV-2 RBD antigen; 2) Detection line (T line) immobilized with SARS-CoV-2 RBD antigen for detecting COVID-19 neutralizing antibody and Control line(C line) immobilized with quality contro! antibody on nitrocellulose membrane. Ifthe sample contains COVID-19 neutralizing antibody, it will bind to antigens coated on colloidal gold, and a pink colored band will develop in the test region (T) on the membrane.If there is no COVID-19 neutralizing antibody in the sample, the pink colored band in the test region (T) will not appears and that suggests a negative result.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2199","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.6","unit":"%","info":"7 on 152"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 on 371"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.65","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.39","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2490","commercial_name":"Saliva Orawell Covid_19 Ag","manufacturer":{"id_manufacturer":"1131","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"https:\/\/www.wellbioscience.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC","Semi-automated"],"target_type":["Antigen"],"specimen":["Other","Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Il test \u00e8 costruito a ciclo chiuso antiadulterante del prelievo, con flacone reagente predisposto all'inserimento del tamponcino_prelievo e utilizzabile come contagocce( senza trasferimento o travasi del prelievo)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2193","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Rapid test Device- CO-03 . registrato come DM n. 2015988\/r al Portale DM del Ministero della Salute","performances":[{"parameter":"LOD","value":"25","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.85","unit":"%","info":"1 su 35"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 su 200"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.57","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"4099","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Self-Testing) (Nasal)","manufacturer":{"id_manufacturer":"1466","name":"JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO. LTD.","country":"China","website":""},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":["SARS-CoV","SARS-CoV-2"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"last_updated":"2022-09-29 09:02:26 CET","testList":[{"id_test":"3887","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"500","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"93.55","unit":"%"},{"parameter":"Analytical Specificity","value":"99.9","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"strips"},{"parameter":"False negatives","value":"8","unit":"strips"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.61","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.55","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"}]}]},{"id_device":"2963","commercial_name":"DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit","manufacturer":{"id_manufacturer":"3182","name":"Jiangxi Province JinHuan Medical Instrument Co. Ltd.","country":"China","website":"http:\/\/www.jinhuan123.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The device is commercialised in Germany and listed at the BfArM under the test-ID \"AT770\/21\". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770\/21 (March 2022).","last_updated":"2022-10-20 10:13:42 CET","testList":[{"id_test":"5221","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.34","unit":"%","info":"Nasal swab"},{"parameter":"False negatives","value":"4","unit":"%","info":"Nasal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.56","unit":"%","info":"Saliva"},{"parameter":"Accuracy","value":"99.07","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Accuracy","value":"98.7","unit":"%","info":"Nasal swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Sensitivity","value":"97.62","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Clinical Sensitivity","value":"92.16","unit":"%","info":"Saliva"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99.64","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Clinical Specificity","value":"98.62","unit":"%","info":"Saliva"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3004","commercial_name":"MEDSYS Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit","manufacturer":{"id_manufacturer":"3227","name":"Jiangxi Province JinHuan Medical Instrument Co. Ltd.","country":"China","website":"http:\/\/www.jinhuan123.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Twin product to \"DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit\" (EU-ID: 2963), packaged under MEDSYS label. \r\n\r\nThe device is commercialised in Germany and listed at the BfArM under the test-ID \"AT770\/21\". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770\/21 (March 2022).","last_updated":"2022-12-12 16:50:20 CET","testList":[{"id_test":"5377","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.34","unit":"%","info":"Nasal swab"},{"parameter":"False negatives","value":"4","unit":"%","info":"Nasal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.56","unit":"%","info":"Saliva"},{"parameter":"Accuracy","value":"99.07","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Accuracy","value":"98.74","unit":"%","info":"Nasal swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Sensitivity","value":"97.62","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Clinical Sensitivity","value":"92.16","unit":"%","info":"Saliva"},{"parameter":"Clinical Specificity","value":"99.66","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99.64","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Clinical Specificity","value":"98.62","unit":"%","info":"Saliva"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3085","commercial_name":"Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit","manufacturer":{"id_manufacturer":"1308","name":"Jiangxi Province JinHuan Medical Instrument Co. Ltd. China","country":"China","website":"http:\/\/www.jinhuan123.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The device is commercialised in Germany and listed at the BfArM under the test-ID \"AT770\/21\". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770\/21 (March 2022). The analytical components of the test are same as the EU device 2963 (https:\/\/covid-19-diagnostics.jrc.ec.europa.eu\/devices\/detail\/2963). However, it has new instructions of use along with new specimen collection methods and respective clinical data.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2791","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Clone1 binding site: INTNSSP(74-80) Clone2 binding site: GTRNPANN(147-154)","performances":[{"parameter":"LOD","value":"1","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.34","unit":"%","info":"False positive occurs 1 in 297 cases"},{"parameter":"False negatives","value":"4","unit":"%","info":"False negative occurs 4 in 100 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.7","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"658","commercial_name":"Apparatus\u00a0Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing)","manufacturer":{"id_manufacturer":"389","name":"Jiangxi YeLi Medical","country":"China","website":"www.yelimed.cn\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"537","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2528","commercial_name":"ABtex AG","manufacturer":{"id_manufacturer":"1153","name":"JIAXING WISETEST BIO-TECH Co. Ltd.","country":"China","website":"http:\/\/www.biotech-crm.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"The company would like to work with us to sell their products in Switzerland. One requirement from Switzerland is to be listed on your list. More information about the Product: At present, the main detection method for the new coronavirus virus is nucleic acid detection, which has strict requirements on detection equipment and personnel. Therefore, the establishment of a detection method with faster detection time, easier operation, and lower cost is of great significance to the control of the epidemic. The saliva novel coronavirus antigen detection kit independently developed by JIAXING WISETEST BIO-TECH CO., LTD. is used for people who have symptoms in the early stage of infection (window period). Highly sensitive, convenient saliva collection, 15 minutes on-site results. The tested person can operate and interpret by himself, which is convenient and quick. There is no need for sample collection, storage, transportation and testing equipment.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2232","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","info":"none"},{"parameter":"False negatives","value":"11","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%","info":"Highly sensitiv"},{"parameter":"Clinical Specificity","value":"95","unit":"%"}]}]},{"id_device":"2151","commercial_name":"SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"996","name":"JINAN BABIO BIOTECHNOLOGY Co. Ltd.","country":"China","website":"zhou@jnbaibo.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay intended for the qualitative detection of nucleoprotein from SARS-CoV-2 nasal swab. It is used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with individuals suspected of COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2890","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.33","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.83","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.67","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"4046","commercial_name":"SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"996","name":"JINAN BABIO BIOTECHNOLOGY Co. Ltd.","country":"China","website":"zhou@jnbaibo.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Oropharyngeal swab","Saliva"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A H1N1","Influenza B","MERS-CoV","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay intended for the qualitative detection of nucleoprotein \r\nfrom SARS-CoV-2 nasal swabs and pharyngeal swabs. It is used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with individuals suspected of COVID-19.\r\nResults from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.","last_updated":"2022-09-20 14:32:24 CET","testList":[{"id_test":"3828","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"N.A.","detection_principle":"N.A.","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"%"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"96.67","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.33","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.4","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.67","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"575","commercial_name":"(COVID-19) IgM\/IgG Antibody Fast Detection Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"545","name":"JinHuan Medical Instrument Co. Ltd.","country":"China","website":"www.jinhuan123.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"791","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"932","commercial_name":"ProTect Covid-19 RT-qPCR kit","manufacturer":{"id_manufacturer":"509","name":"JN Medsys","country":"Singapore","website":"jnmedsys.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"733","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"90","notes":" https:\/\/jnmedsys.com\/covid19\/","performances":[{"parameter":"LOD","value":"10","unit":"copies\/reaction"}]}]},{"id_device":"2875","commercial_name":"\/COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal - self testing device","manufacturer":{"id_manufacturer":"44","name":"Joinstar Biomedical Technology Co. Ltd.","country":"China","website":"www.joinstar.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"No.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2580","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"100pg\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.8","info":"4 false positives in 500 negatives"},{"parameter":"False negatives","value":"3.92","info":"4 false negatives in 102 positives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.7","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.1","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1205","commercial_name":"COVID-19 Antigen Rapid Test (Latex)","manufacturer":{"id_manufacturer":"44","name":"Joinstar Biomedical Technology Co. 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It is listed as \"Joysbio SARS-CoV-2 Antigen rapid test kit - PRO (Colloidal Gold)\" in the PEI evaluation list. ","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2518","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"120","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.44","unit":"%","info":"1 out of 224 RT-PCR negative specimens"},{"parameter":"False negatives","value":"1.81","unit":"%","info":"2 out of 110 RT-PCR positive specimens"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.1","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.18","unit":"%"},{"parameter":"Clinical Specificity","value":"99.55","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"25665","commercial_name":"Test.11.12.2024","manufacturer":{"id_manufacturer":"17450","name":"JRC","country":"Italy","website":""},"ce_marking":"Yes","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated"],"target_type":["Nucleic acid"],"specimen":["ACD plasma"],"pathogen":["Adenovirus"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""}],"target":["angiotensin-converting enzyme 2"],"last_updated":"2024-12-11 10:24:09 CET","testList":[{"id_test":"21164","assay_category":"Nucleic acid-PCR","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"CRISPR","measurement":"Qualitative","subclass":"WHO-2","detection_principle":"Absorbance","subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2899","commercial_name":"LifePad Analyzer","manufacturer":{"id_manufacturer":"1281","name":"K.K. 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The Analyzer is designed to perform the viral RNA extraction from the patient's nasopharyngeal, oropharyngeal or combined oro- and nasopharyngeal swab, and subsequent real-time amplification. The Analyzer's operating principle is based on three main procedures: Lysis - viral envelope destruction in chaotropic salts. RNA extraction from a specimen - RNA binding to the glass filter. Detection - real-time amplification. Note: Analyzer is operable only with the Test Cartridge from Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method (Mirai Genomics, Japan). The system is completely closed. The Test Cartridge contains all the required reagents. The Analyzer does not interact with the reagents inside the Test Cartridge in any way. Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method are not supplied with the system and must be purchased separately. For ordering information, contact Mirai Genomics. The Analyzer is intended for use in clinical diagnostic laboratories, as well as research institutes laboratories. The Analyzer is intended for in vitro diagnostics only. 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Results are used for the SARS-CoV-2 RNA identification. Positive results are indicative of the SARS-CoV-2 RNA presence. To determine a patient\u2019s infection status, clinical comparability with patient clinical history and other diagnostic information is required. Negative results do not preclude the SARS-CoV-2 infection and should not be used as the sole basis for treatment. Negative results must be combined with clinical observations, patient clinical history, and epidemiological information. The Kit is intended to be performed by trained users in both laboratory and near patient testing settings. 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\u00c5\u017eT\u00c4\u00b0","country":"Turkey","website":"www.labormed.biz"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Throat swab"],"pathogen":["Coronaviruses (HCoV)","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","SARS-CoV"],"lineage":[],"target":["nucleocapsid protein"],"notes":"www.labormed.biz","last_updated":"2022-08-24 09:08:01 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Diagnostica","country":"Brazil","website":"labtest.com.br\/en\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"466","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[{"parameter":"False positives","info":"Evaluated"},{"parameter":"False negatives","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"85","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"96","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"98","unit":"% IgG"}]}]},{"id_device":"1667","commercial_name":"LooK SPOT","manufacturer":{"id_manufacturer":"746","name":"Laipac Technology Inc.","country":"Canada","website":"www.laipac.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated"],"target_type":["Antigen"],"specimen":["Nasal 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Look SPOT access AI Cloud for the diagnosis of the images and it provides consistent test results including low positive cases. Under SPEED mode, it can provide test results within 30 seconds.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1346","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Other","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"1","performances":[{"parameter":"LOD","value":"129000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"%","info":"Limited to less than 2%"},{"parameter":"False negatives","value":"2","unit":"%","info":"Limited to less than 2%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%"},{"parameter":"Clinical Specificity","value":"98.3","unit":"%"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"2368","commercial_name":"LooK SPOT 2","manufacturer":{"id_manufacturer":"746","name":"Laipac Technology Inc.","country":"Canada","website":"www.laipac.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Other"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"LooK SPOT 2 can screen 500+ people in one hour by using SPEED mode. LooK SPOT 2 uses AI Cloud to validate the test result and provide traceability in real time. Patients can receive test certificates on their phones in real time.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2070","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"1","performances":[{"parameter":"LOD","value":"129000","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"%","info":"Limited to less than 2%"},{"parameter":"False negatives","value":"2","unit":"%","info":"Limited to less than 2%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%"},{"parameter":"Clinical Specificity","value":"98.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"256","commercial_name":"Real time RT-PCR Kit for the detection of SARS-CoV-2","manufacturer":{"id_manufacturer":"156","name":"Landcent Europe B.V.","country":"Netherlands","website":"www.landcent.nl\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"207","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"3092","commercial_name":"COVID-19 Antigen Test Kit (Colloidal gold immunochromatographic assay)","manufacturer":{"id_manufacturer":"1372","name":"Langfang Xinruikang Biotechnology Co. 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Ltd.","country":"China","website":"en.lansionbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Lab-based","Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1330","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Quantitative","subclass":"Fluorescence","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","unit":"%"},{"parameter":"False negatives","value":"3","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96","unit":"%","info":"(IgM, IgG)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.14","unit":"%","info":"(IgM, IgG)"}]}]},{"id_device":"2869","commercial_name":"COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay)","manufacturer":{"id_manufacturer":"739","name":"Lansion Biotechnology Co. 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Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also bean infectious source. Based on the current epidemiological investigation, the incubation period for COVID-19 ranges from 1 to 14 days, with most cases ranging from 3 to 7days, the main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose,sore throat, myalgia, and diarrhea are found in a few cases.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2574","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"2.5","unit":"\u00b5g\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"0","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.29","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"96.37","unit":"%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"3123","commercial_name":"COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) for self-testing use","manufacturer":{"id_manufacturer":"739","name":"Lansion Biotechnology Co. 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The N protein in the sample binds to the gold-labeled SARS-CoV-2 N protein mouse anti human monoclonal antibody 1 pre-coated on the binding pad, and the conjugate moves upward under capillary action. If the sample contains the novel coronavirus antigens and concentration of antigens is higher than the limit of detection, the antigen will bind to the N proteinmouseanti human monoclonal antibody.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2831","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) detects the SARS-CoV-2 with the principle of antigen-antibody reaction. The test strip contains (1) coated with red latex microspheres labeled SARS-CoV-2 N protein mouse anti human monoclonal antibody 1 and blue latex microspheres labeled chicken IgY fixed on a binding pad, (2) test line (T red) Coated paired SARS-CoV-2 N protein mouse anti human monoclonal antibody 2, quality control line (C blue) coated goat anti chicken IgY antibody fixed on a nitrocellulose membrane. T is fixed with anti-SARS-CoV-2 antibody for detecting the novel coronavirus. The quality control antibody is fixed on the C line. The immune complex will be captured by the anti-SARS-CoV-2 antibody immobilized on the membrane, forming a red T line and indicating a positive result for the novel coronavirus. The higher the N protein content in the sample, the more conjugates will be captured and the darker the color of the test line (T red). Additionally, the test Strip also contains a quality control line (C blue). Regardless of whether there is a virus in the sample, a blue band will appear in the control line (C blue). What appears in the Control Line (C blue) is the standard for judging whether there are enough samples and whether the chromatographic process is normal. If the C line does not appear it indicates that the test result is invalid and the sample is required to retest.","performances":[{"parameter":"LOD","value":"2.5","unit":"\u00b5g\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.54","unit":"%","info":"After comparison of clinical test, there were7 false positives for 454 positive samples."},{"parameter":"False negatives","value":"5.45","unit":"%","info":"After comparison of clinical test, there were 6 false negatives for 110 positive samples."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.7","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.54","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"98.46","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1648","commercial_name":"COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)","manufacturer":{"id_manufacturer":"739","name":"Lansion Biotechnology Co. 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disease that is highly susceptible to human infection.Currently, the patients infected by the novel coronavirus are the main source of infection,asymptomatic infected people can also bean infectious source.Based on the current epidemiological investigation, the incubation period for COVID-19 ranges from 1 to 14 days,with most cases ranging from 3 to 7days,the main manifestations include fever,fatigue,and dry cough.Nasal congestion,runny nose,sore throat,myalgia, and diarrhea are","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2523","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Quantitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"AU"},{"parameter":"False 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CET","testList":[{"id_test":"208","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"258","commercial_name":"Leadgene SARS\/SARS-CoV-2 IgG\/IgM Rapid Test Kit","manufacturer":{"id_manufacturer":"157","name":"Leadgene Biomedical Inc.","country":"Taiwan ROC","website":"www.leadgenebio.com\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 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Only 3 steps and a specific device (LoopDeeLab) to have a result.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2327","assay_category":"Unknown","rapid_diagnostic":null,"self_test":"No","reader_required":"Yes","method":"LAMP","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"45","performances":[{"parameter":"Positive control","info":"co-amplification of actb gene"},{"parameter":"Analytical Sensitivity","value":"95","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2094","commercial_name":"COVID19AgLTFLOW","manufacturer":{"id_manufacturer":"970","name":"LT Biotech JSC","country":"Lithuania","website":"www.ltbiotech.lt"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"Additional validation is performed in third party laboratory in 2021-12-03","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1777","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Enzyme-linked","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"\u00b5g"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"20","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.12","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.01","unit":"%"},{"parameter":"Clinical Specificity","value":"99.52","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2654","commercial_name":"LUCA NK COVID-19 Ag LLB","manufacturer":{"id_manufacturer":"1214","name":"LUCA AICELL Inc.","country":"South Korea","website":"http:\/\/lucaaicell.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"}],"target":["nucleocapsid protein"],"notes":"Regarding your question on the swabs, there is no distinction between nasal and nasopharyngeal. Our swabs can be used for both nasal and nasopharyngeal. Therefore, we have included only 25 swabs. Does this clarify your question?","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2359","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"2","unit":"ng\/mL","info":"Nucleocapsid protein recombinant antigen"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"3","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Antigen"},{"parameter":"Clinical 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","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1138","assay_category":"Nucleic acid-PCR","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"LAMP","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"900","unit":"copies\/ml"},{"parameter":"False positives","value":"94","unit":"%"},{"parameter":"False negatives","value":"98","unit":"%"}]}]},{"id_device":"580","commercial_name":"Microchip RT-PCR COVID-19 detection system","manufacturer":{"id_manufacturer":"350","name":"Lumex Instruments","country":"Canada","website":"www.lumexinstruments.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"468","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2128","commercial_name":"PocRoc\u00aeSARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"986","name":"Lumigenex (Suzhou) Co. 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Until now, there is no negative feedback from the market. After being listed by BfArM with AT455\/20, the PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) has positive results by PEI on Mar. 15,2021.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1818","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"121","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.84","unit":"%"},{"parameter":"False 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protein"],"notes":"HOW ARE EON BIOTECHNOLOGY\u2019S PRODUCTS BETTER? Eon Biotechnology controls biotechnology assets which include clones for SARS-CoV2 antigens & antibodies, vaccine platforms, ScFv libraries for SARS-CoV-2 antibodies and the derived immunodiagnostic & therapeutic products with a specific purpose of translation & commercialization across the world. This platform technology is leveraged for COVID-19 currently and eventually to other emerging infectious diseases and lifestyle disease conditions. Eon operates a compliant biotherapeutic infrastructure with governing structure for \u2018Genetic Engineering Approval Committee\u2019, Animal Ethics Committee, and Institutional Ethics committee and product approvals from an R&D perspective. CE certificate in Europe, EN ISO 13485, ISO 9001, WHO \u2013 GMP and other requisite infrastructure compliances form the quality support system behind products of Eon Biotechnology. Eon Biotechnology\u2019s offerings are backed by: 1. Technology refined by experience in deep research. 2. Physical infrastructure - associated hospitals that attend to COVID-19 positive subjects every day & therefore a constant real time opportunity to monitor & test improved versions of the test. 3. Physical manufacturing infrastructure capable of producing large volumes of tests. 4. EONbtTM COVID-19 Rapid Antigen test is a quality driven product backed by comprehensive real time know-how and infrastructure. Background of SARS-COV-2: SARS-CoV-2 is a novel, zoonotic coronavirus that emerged in late 2019 in patients with pneumonia of unknown cause. The virus was named SARS-CoV-2 because of its similarity to the coronavirus responsible for severe acute respiratory syndrome (SARS-CoV, a lineage B betacoronavirus). SARS-CoV-2 is an enveloped, positive sense, single stranded RNA virus sharing more than 70% of its sequence with SARS-CoV, and ~50% with the coronavirus responsible for Middle Eastern respiratory syndrome (MERS-CoV).The SARS-CoV-2 spike glycoprotein (S), which is a main target for neutralizing antibody, binds to its receptor human angiotensin converting enzyme 2 (hACE2) to initiate infection.SARS-CoV-2 is the cause of COVID-19, an infectious disease with respiratory and systemic manifestations. Disease symptoms vary, with many persons presenting with asymptomatic or mild disease and some progressing to severe respiratory tract disease including pneumonia and acute respiratory distress syndrome (ARDS), leading to multi organ failure and death. Corona virus can be extracted through respiratory secretions or transmitted through oral fluid, sneezing, physical contact, and other air droplets. There are 2 main proteins involved and necessary for the infection of humans by coronavirus. These are: 1. Spike protein (which is a trimeric protein containing 3 different sub-units, among three subunits subunit S2 is highly conserved and subunit S1 is essential to make an entry into the host cell). 2. Nucleocapsid protein which is essential for viral assembly. 3. These 2 proteins play an important role in the infection and viral life cycle in human beings. They are the potential target molecules in the development of rapid tests for detection of coronavirus infection in humans. EXECUTIVE SUMMARY: EONbtTM COVID-19 ANTIGEN-SALIVA is marketed by EON BIOTECHNOLOGY LTD., U.K and manufactured by Angstrom Biotech Private Limited is intended for Point of Care (POC) diagnosis of coronavirus infection. The product is CE approved in Europe. COVID-19 ANTIGEN-SALIVA is a lateral flow immunoassay intended for in vitro qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in saliva specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset. This test is designed for Point of Care use, as an aid to early diagnosis of SARS-CoV-2 infection in patients with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. The administration of the test and the interpretation of the results should be done by a trained health professional. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required. EONbtTM COVID-19 ANTIGEN-SALIVA is an antigen-capture immunochromatographic assay, detecting presence of COVID-19 viral nucleoprotein antigen in saliva samples. The detection kit uses the principle of immunochromatography: separation of components in a mixture through a medium using capillary force and the specific and rapid binding of an antibody to its antigen. Why Saliva? Infrastructure Benefits: Nasopharyngeal and oropharyngeal swabs are inconvenient to collect and pose a transmission risk to healthcare workers due to coughing induced during the collection process. The Saliva sampling method will allow for broader population screening than the current method of nose and throat swabs. It allows people of any ability to be tested for SARS-COV-2. The impact of using Saliva samples is significant. It means health care professionals are not at risk of contracting the COVID-19 infection by administering Saliva tests when compared with performing nasopharyngeal or oropharyngeal collections. The saliva sample method preserves precious personal protective equipment (PPE) for use in vital patient care in hospitals instead of testing. The number of people tested every day can be significantly increased as sampling of saliva is quicker and more scalable than swab collections. 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CET","testList":[{"id_test":"493","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"278","commercial_name":"One-step Direct Realtime PCR Test Kit of 2019-nCoV Coronavirus","manufacturer":{"id_manufacturer":"173","name":"MedStar Medical Co. Ltd.","country":"United States","website":"www.medstarhealth.org\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"229","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2905","commercial_name":"MeduFlow","manufacturer":{"id_manufacturer":"1284","name":"Medusa19 Life Sciences","country":"United Kingdom","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["spike protein"],"notes":"The product is the first uk test to achieve home use approval.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2610","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"AU"},{"parameter":"False negatives","value":"4","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.6","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.9","unit":"%"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"1182","commercial_name":"Rapid COVID-19 Antigen Qualitative Test Kit","manufacturer":{"id_manufacturer":"77","name":"Megna Health Inc.","country":"United States","website":"www.megnahealth.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Other","Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"Megna Health requests the addition of this IVD Test Kit to the CE approved listing. The device is manufactured by Megna Health - and the EU Authorized Representative is MDSS (Germany). Notification of this COVID IVD has been made to the Competent Authority in Germany","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"964","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[]}]},{"id_device":"1063","commercial_name":"Rapid COVID-19 IgM\/IgG Combo Test Kit (Antibody)","manufacturer":{"id_manufacturer":"77","name":"Megna Health Inc.","country":"United States","website":"www.megnahealth.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["ACD plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"notes":"The Megna Rapid COVID-19 IgM\/IgG Combo Test Kit has been exhaustively tested - by Megna Health and by independent testing conducted by National Institute of Health and National Cancer Society - as required by FDA prior to issuing an Emergency Use Authorization letter on July 17, 2020.; https:\/\/www.megnahealth.com\/wp-content\/uploads\/2020\/07\/MegnaHealth-Test-Kit_-IFU.pdf","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"97","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"83.3","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"97.5","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"97.5","unit":"% IgM"}]}]},{"id_device":"1894","commercial_name":"COVID-19 Antigen Detection Test","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"COVID-19 Antigen Detection Test is a rapid immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab from human. For professional use.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1571","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"250","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.6","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2923","commercial_name":"COVIFIND COVID-19 Antigen Self Test","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Product is CE certified by the notifying body PCBC 1434","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2628","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"LOD of COVIFIND Covid-19 antigen Self Test is \u2265 933 TCID50\/ml."},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"The product is having zero False positive, specificity is 100%"},{"parameter":"False negatives","value":"1.75","unit":"%","info":"The product is having sensitivity of 98.25%, Gives 1.75% false negative results"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.25","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.25","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2924","commercial_name":"COVIFIND COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Product is Self CE certified, notified with Obelis, the EU Rep","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2629","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"LOD of COVIFIND Covid-19 antigen Self Test is \u2265 933 TCID50\/ml."},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"The product is having zero False positive, specificity is 100%"},{"parameter":"False negatives","value":"1.75","unit":"%","info":"The product is having sensitivity of 98.25%, Gives 1.75% false negative results"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.25","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.25","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"792","commercial_name":"Meril COVID-19 One-step RT-PCR Kit","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"635","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"120","notes":" Information provided by the manufacturer: Meril COVID-19 One step RT-PCR Kit is intended for qualitative detection of nucleic acid from SARS-CoV-2 using real time PCR from Human nasal, nasopharyngeal, oropharyngeal swab specimens, and bronchoalveolar lavage samples. The results can be used to assist diagnosis of patients with COVID-19 infection. The Meril COVID-19 One step RT-PCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Summary and explanation of the test: The Meril COVID-19 One-step RT-PCR Kit is a qualitative test uses nucleic acid amplification technology and the standard hydrolysis probe system .The Human RNase P Internal Control is used to monitor the entire sample preparation and PCR amplification process. In addition, the test utilizes external controls (positive control and a negative control(DEPC-treated H2O).Principle:The primer and probe mix for this kit adopts the dual-target gene design, which targets the specific conserved sequence encoding the ORF 1ab gene and the nucleoprotein N gene. With the PCR reaction mix provided, the amplification of template can be quantitatively monitored by the increasing fluorescence signal detected by a real time PCR instrument.The PCR detection system includes an endogenous internal control primer and probe mix. The result of internal control provides the accuracy of sampling and extraction process, in order to avoid false negative results.Instrument Compatibility:This kit is compatible with real time PCR instruments with FAM, HEX\/VIC, RED\/ROX channels.","performances":[{"parameter":"LOD","value":"0.5","unit":"cpu","info":" "},{"parameter":"Positive control","info":"Positive control is provided with the kit."},{"parameter":"Negative control","info":"No template control is provided with the kit. The test utilizes external controls (positive control and a negative control(DEPC-treated H2O)"},{"parameter":"Analytical Sensitivity","value":"100"},{"parameter":"Analytical Specificity","value":"100"},{"parameter":"Clinical Sensitivity","value":"100"},{"parameter":"Clinical Specificity","value":"100"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"2582","commercial_name":"MERISCREEN COVID-19 Antigen Detection Test","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The product is clinically tested, validated and approved by Indian council of medical research (ICMR). Notified with European Union with the EU Representative Obelis SA from Belgium having EAR certificate.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2287","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","info":"MERISCREEN COVID-19 Antigen Detection Test is \u2265 933 TCID50\/ml."},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"The product is having zero False positive, specificity is 100%"},{"parameter":"False negatives","value":"2.88","unit":"%","info":"The product is having sensitivity of 97.12%, Gives 2.88% false negative results"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.12","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.12","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2029","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette","manufacturer":{"id_manufacturer":"933","name":"Merlin Biomedical (Xiamen) Co. Ltd.","country":"China","website":"http:\/\/www.merlinbio.com.cn\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"BfArM Vorgangsnummer: AT214\/20 Certificate T\u00dcV S\u00fcd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01\/1-16963-00006-IVD","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1707","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"160","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","unit":"AU"},{"parameter":"False negatives","value":"1","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.05","unit":"%"},{"parameter":"Clinical Specificity","value":"98.99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2596","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette","manufacturer":{"id_manufacturer":"1182","name":"Merlin Biomedical (Xiamen) Co. Ltd.","country":"China","website":"http:\/\/www.merlinbio.com.cn\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody"],"specimen":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"This cassette belongs to in vitro diagnostic reagents, and is suitable for the qualitative cietection cf SARS-CoV-2's Nucleocapsid protein in human saliva specimen. It cannot be served as the basis of the confirmation or exclusion for coronavirus pneumonia. This product is used only far medicai institutions. The positive test result requires further confirmation. A negative test cannot rule out the possibility of infection. The test results of this cassette are only for clinica! reference. It is recommended to conduct a comprehensive analysis of the patient's condition in combination with clinical manifestations and other laboratory tests. A total of 443 clinical samples were tested in this clinical study. The clear diagnosis and exclusion criteria of the \"SARS-CoV-2 diagnosis and treatment protocol\" were taken as a reference. Clinical trials were conducted at Fujian's Fuzhou Lung Hospital and Zhangzliou Hospital. The positive coincidence rate of the SARS-CoV-2 Antigen Rapid Test Cassette, developed by Merlin was 95.5% and the negative coincidence rate of the cassette was 99.7%, the total coincidence rate of the cassette was 98 , 4% compared to the reference method (RT-PCR) which indicates a high consistency.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2301","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.5","unit":"%","info":"Positive coincidence rate = 127\/ (127+6) x100%=95.5%, (95% Cl: 90.5%-98.0%)"},{"parameter":"False negatives","value":"0.3","unit":"%","info":"Negative coincidence rate = 299\/ (299+1) x100%=99.7%, (95% Cl: 98.1%-99.9%);"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":" (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2030","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette (saliva)","manufacturer":{"id_manufacturer":"933","name":"Merlin Biomedical (Xiamen) Co. 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https:\/\/www.meslo.com\/category\/704\/Coronavirus-qPCR-test-Kits--and--Rapid-Kits-COVID-19.html","performances":[{"parameter":"LOD","value":"100","unit":"copies\/reaction"}]}]},{"id_device":"1928","commercial_name":"ImmTek COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"882","name":"Metas Biomedical Inc.","country":"Taiwan ROC","website":"www.metasbiomedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab","Nasopharyngeal 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","last_updated":"2022-12-07 08:48:05 CET","testList":[{"id_test":"5363","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunoassay","measurement":"Quantitative","subclass":"Neutralization Antibody (NAb)","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"1","performances":[{"parameter":"LOD","value":"100","unit":"%"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"99","unit":"%"},{"parameter":"Analytical Specificity","value":"99","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"% IgG"},{"parameter":"False negatives","value":"1","unit":"% IgG"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"}]}]},{"id_device":"2795","commercial_name":"Coronavirus disease 2019(COVID-19) Detection Kit, nCoV-OS","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. 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This Kit is designed as a professional use In Vitro diagnostic medical device with experience in molecular diagnosis experiments. This test can help diagnose infections of individual suspected of coronavirus disease 2019. Consultation with a medical specialist is required for final diagnosis. Calibration of the system is traceable to SARS-CoV-2 RNA NCCP 43326","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2504","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"RT-PCR","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"100","performances":[{"parameter":"LOD","value":"299.535","unit":"cpm"},{"parameter":"Positive control","info":"SARS-CoV-2 Positive Control Material"},{"parameter":"Negative control","info":"Nuclease Free Water"},{"parameter":"Analytical Sensitivity","value":"95","unit":"%"},{"parameter":"Analytical Specificity","value":"95","unit":"%"}]}]},{"id_device":"2798","commercial_name":"Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-VM","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Near POC \/ POC"],"target_type":["Nucleic acid"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"This Real-time PCR kit is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab specimens from individuals who are suspected of COVID-19. Saliva samples can also be tested, and saliva should be collected using the Veri-Q saliva collection kit (MiCo BioMed, Cat No. 7K401). Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2503","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"RT-PCR","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"100","performances":[{"parameter":"LOD","value":"301.1","unit":"cpm","info":"QD-P100"},{"parameter":"LOD","value":"126.1","unit":"cpm","info":"CFX96"},{"parameter":"LOD","value":"273.8","unit":"cpm","info":"ABI7500"},{"parameter":"Positive control","info":"SARS-CoV-2 Positive Control Material"},{"parameter":"Negative control","info":"Nuclease Free Water"},{"parameter":"Analytical Sensitivity","value":"95","unit":"%"},{"parameter":"Analytical Specificity","value":"95","unit":"%"},{"parameter":"Clinical Sensitivity","value":"99.36","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2793","commercial_name":"COVID-19 Biokit IgG\/IgM","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The COVID-19 Biokit IgG\/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG\/IgM is suitable for professional use. The COVID-19 Biokit IgG\/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG\/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG\/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG\/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2498","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","info":"PRNT50: 20"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"9.91","unit":"%"},{"parameter":"False negatives","value":"0.25","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.74","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"90.09","unit":"%","info":"95% CI, 85.33% - 93.43%"},{"parameter":"Clinical Specificity","value":"99.75","unit":"%","info":"95% CI, 99.1% - 99.93%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"2827","commercial_name":"MiCo BioMed Co., Ltd.","manufacturer":{"id_manufacturer":"1254","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The COVID-19 Biokit IgG\/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG\/IgM is suitable for professional use. The COVID-19 Biokit IgG\/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG\/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG\/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG\/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2532","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","info":"PRNT50: 20"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"9.91","unit":"%"},{"parameter":"False negatives","value":"0.25","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.74","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"90.09","unit":"%","info":"95% CI, 85.33% - 93.43%"},{"parameter":"Clinical Specificity","value":"99.75","unit":"%","info":"95% CI, 99.1% - 99.93%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"2801","commercial_name":"Veri-Q COVID-19 & Flu A\/B Multiplex Detection Kit","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Near POC \/ POC"],"target_type":["Nucleic acid"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Veri-Q COVID-19 & Flu A\/B Multiplex Detection Kit is a one-step reverse transcription real-time PCR method that uses nucleic acids extracted from NP(Nasopharyngeal) and NP\/OP (Nasopharyngeal\/ Oropharyngeal) mixed swab specimens from patients with respiratory infections. This is an in-vitro diagnostic medical device that simultaneously detects SARS-CoV-2 and flu-causing virus Influenza A\/B.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2506","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"RT-PCR","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"100","performances":[{"parameter":"LOD","unit":"cpr","info":"Influenza A\/B - 6.3~100 cpr"},{"parameter":"LOD","unit":"cpr","info":"SARS-CoV-2 - 50 cpr"},{"parameter":"Positive control","info":"Synthetic DNA of ORF3a and N gene of SARS-CoV-2, and M gene"},{"parameter":"Negative control","info":"PCR grade water for negative control to check contamination"},{"parameter":"Analytical Sensitivity","value":"95","unit":"%"},{"parameter":"Analytical Specificity","value":"95","unit":"%"},{"parameter":"Clinical Sensitivity","value":"97.14","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2792","commercial_name":"VERI-Q COVID-19 Ag Rapid Test","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"The VERI-Q COVID-19 Ag Rapid Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swab and nasopharyngeal swab from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in sterilized swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The VERI-Q COVID-19 Ag Rapid Test is intended for use by medical professionals who are proficient in performing rapid lateral flowtests.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2497","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"1000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"12.5","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.85","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"95% CI: 86.3 % ~ 99.9 %"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI: 97.7 % - 100 %"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2789","commercial_name":"Veri-Q COVID-19 IgG ELISA Kit","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["IgG"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"notes":"The VERI-Q COVID-19 IgG ELISA Kit is a microplate based enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to SARS-CoV-2 present in human plasma or serum from patients suspected of COVID-19 infection. The VERI-Q COVID-19 IgG ELISA Kit is intended for use by the clinical laboratory personnel specifically trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures The VERI-Q COVID-19 IgG ELISA Kit is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of oth er laboratory tests.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2494","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Qualitative","subclass":"Enzyme-linked","detection_principle":null,"subcategory":null,"time_minutes":"100","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"0.7 < O.D. < 1.1"},{"parameter":"False negatives","info":"0.7 < O.D. < 1.1"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2790","commercial_name":"Veri-Q COVID-19 SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"notes":"The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit is in vitro diagnostic test intended for the qualitative detection of neutralization antibody to SARS-CoV-2 in human serum or plasma (EDTA, heparin, citrate). The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit should not be used to diagnose acute SARS-CoV-2 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2495","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"70","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"O.D. > 0.1"},{"parameter":"False negatives","info":"O.D < 1.0"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"94.4","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"280","commercial_name":"VERI-Q PCR 316 COVID-19 detection system","manufacturer":{"id_manufacturer":"1254","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"There is the change for CE marking","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"230","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[{"parameter":"Throughput","info":"lab on a chip"}]}]},{"id_device":"2791","commercial_name":"Veri-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is a lateral flow immunoassay intended for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human plasma from anticoagulated blood, serum, finger-stick whole blood or venous whole blood samples. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2496","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Specificity","value":"95.6","unit":"%"}]}]},{"id_device":"2805","commercial_name":"Veri-Q Viral DNA\/RNA Prep Kit","manufacturer":{"id_manufacturer":"1254","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Semi-automated"],"target_type":["Nucleic acid"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Plasma","Saliva","Serum","Sputum"],"pathogen":[],"lineage":[],"target":[],"notes":"16TU-CV19 is a reagent kit for extraction of Viral DNA\/RNA from Airway Sample (Swab media, Sputum and ETC) using Veri-Q M16, G2-16TU. This kit also can use for extraction of total DNA\/RNA and cell free DNA (cfDNA) from serum and plasma sample","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2510","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Other","measurement":"Other","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"60","performances":[]}]},{"id_device":"737","commercial_name":"COVID-19 Key","manufacturer":{"id_manufacturer":"438","name":"MicroGenDx","country":"United States","website":"www.microgendx.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"597","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2179","commercial_name":"ASAPath COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1015","name":"Microgenics Corporation","country":"United States","website":"www.thermofisher.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"}],"target":[],"notes":"Subclass: Enzyme-linked and Sandwich. 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Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. 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Testing flexibility: either single gene screening or precision dual gene diagnostics. E or RdRP gene (based on the end-user preference) can be exclusively used for 400 screening tests. This option is recommended when manysymptomatic patients have to be screened at once. The precision dual gene option is based on running 200 screening assays first (E or RdRP gene) followed by 200 confirmation assays to confirm positive screening results (E or RdRP gene) or eliminate false-positive results. In addition, conducting an internal control assay for human RNase P assesses appropriate swab and RNA extraction, the presence of human RNA within the extracted sample, while eliminating false-negative results. Thus, for the precision dual gene diagnostics workflow, two testing reactions(screening and confirmation) should be performed per one patient and this option is recommended when precision testing is essential.","performances":[{"parameter":"LOD","value":"2","unit":"copies\/reaction"},{"parameter":"LOD","value":"0.4","unit":"copies\/\u03bcl"},{"parameter":"Positive control","info":"full genomic RNA of coronavirus SARS-COV-2 + human RNA "},{"parameter":"Negative control","info":"nuclease-free water (PCR water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run","info":"96 samples per run"}]}]},{"id_device":"2960","commercial_name":"Vivid COVID-19 LAMP Direct-G","manufacturer":{"id_manufacturer":"580","name":"MultiplexDX s.r.o.","country":"Slovakia","website":"www.multiplexdx.coom"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":null,"specimen":["Other biological fluids","Sputum","Throat secretion"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["envelope protein","nucleocapsid protein","ORF1ab polyprotein"],"notes":"The Vivid COVID-19 LAMP Direct-G diagnostic kit is an internally developed LAMP test for the detection of SARS-CoV-2 virus suitable for visual detection of the presence of SARS-CoV-2 RNA. The assay is one-step, i.e., involves RT and LAMP amplification in one reaction (RT-LAMP). In addition, this assay is designed to work with only minimally processed gargle samples with no prior RNA extraction required; samples only have to be heated\/incubated with the provided inactivation reagent as per instructions before setting up the reaction. The kit contains a set of primers for the multiplexed detection of SARS-CoV-2 E, ORF1ab and N genes. This primer mix was specifically designed and optimized so that primer interactions do not lead to non-specific amplification products and thus to false positive results that are relatively common to the LAMP method. At the same time, multiplexed LAMP detection significantly increases the sensitivity and reduces the variation in detection time. The second set of primers is intended for the detection of the human RNase P gene, which serves as an internal control to verify correct patient material sampling, sample processing, RNA integrity, and test execution. While sequence-wise this primer set does not distinguish between genomic DNA and messenger RNA it does show significantly increased sensitivity towards RNA substrates in practice. The complete genomic RNA of the SARS-CoV-2 virus enriched with human RNA provided by the Biomedical Center of the Slovak Academy of Sciences is included as an internal positive control. For testing, two dry block heaters capable of heating samples to at least 95 \u00b0C are sufficient. In addition, the kit contains a patented proprietary colorimetric detection system, which is not sensitive to the pH of the input sample. With this system positive samples show a reliable color change from magenta to yellow which is easily visible by the naked eye.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2666","assay_category":"Nucleic acid-Other","rapid_diagnostic":null,"self_test":"N.A.","reader_required":"No","method":"LAMP","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"40","performances":[{"parameter":"LOD","value":"1000","unit":"cpm"},{"parameter":"Positive control","info":"RNA isolated from cell cultured SARS-CoV-2"},{"parameter":"Negative control","info":"PCR water"},{"parameter":"Analytical Sensitivity","value":"95","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"92.1","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"2359","commercial_name":"COMPACT MINI\/DX\/XLDX- Nucleic Acid Amplification (PCR) Analyzer","manufacturer":{"id_manufacturer":"1081","name":"Mylab Discovery Solutions Pvt. 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Ltd.","country":"China","website":"http:\/\/www.syngenemed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["IgG","IgM"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The novel coronaviruses belong to the \u03b2 genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. The common diagnostic methods of COVID-19 pneumonia are CT and PCR. This product is an immunoassay. This product does not require any instruments. It is used for the qualitative detection of COVID-19 IgM \/ IgG antibodies in humans.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2528","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.5","unit":"%"},{"parameter":"False negatives","value":"0.5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.5","unit":"%"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"3525","commercial_name":"COVID-19\/Influenza A+B Antigen Combo Rapid Test Kit (Colloidal gold method)","manufacturer":{"id_manufacturer":"1007","name":"Nanjing Synthgene Medical Technology Co. 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Ltd.","country":"China","website":"http:\/\/www.syngenemed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The product is used for the qualitative detection of SARS-COV-2 infection. No instrument required. It can be used for the screening of early infected patients and asymptomatic patients. The test can be performed at the patient\u2019s medical facility (POC \u2013 point of care-conditions). The negative result cannot rule out novel coronavirus infection, and it can not be used alone as a basis for treatment and disease management decisions.The positive result of the antigen test can be used for early triage and rapid management of suspected infected people, but the positive result only indicates the presence of the novel coronavirus N-Protein (Nucleocapsid) in the sample, and cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by the novel coronavirus. It should be combined with nucleic acid testing, imaging and other diagnostic information, medical history, and contact history to determine the status of infection. Coronavirus belongs to the order Nidoviridae, and the coronavirus family is divided into three genera of \u03b1 ,\u03b2, and \u03b3. \u03b1 and \u03b2 are only pathogenic to mammals, and \u03b3 mainly causes bird infections. COV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through fecal or oral routes.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1865","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.67","unit":"%"},{"parameter":"False negatives","value":"0.5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.45","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.33","unit":"%"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2822","commercial_name":"SARS-CoV-2 Virus Neutralization Test Kit (Colloidal gold method)","manufacturer":{"id_manufacturer":"1007","name":"Nanjing Synthgene Medical Technology Co. 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The entire detection process only takes 10-15 minutes. It is easy to operate and has high sensitivity. It is convenient for the screening of people vaccinated with the new coronavirus vaccine and the judgment of the effect after vaccination","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2527","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.67","unit":"%"},{"parameter":"False negatives","value":"0.5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.45","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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in the acute (early) phase of SARS-CoV-2 infection, as well as in asymptomatic patients.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1935","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Ares(2021)3832559","performances":[{"parameter":"LOD","value":"6.31","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"There are no false positives"},{"parameter":"False negatives","info":"There are no false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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It provides an aid in the diagnosis of infection with novel coronavirus.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2007","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","info":"1"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"% IgM","info":"1 out of 105"},{"parameter":"False positives","value":"0.95","unit":"%","info":"1 out of 105"},{"parameter":"False negatives","value":"2.04","unit":"%","info":"2 out of 98 "},{"parameter":"False negatives","value":"5.1","unit":"% IgM","info":"5 out of 98"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"% IgM"},{"parameter":"Accuracy","value":"98.5","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.9","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"94.9","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"99","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99","unit":"% IgM"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1501","commercial_name":"COVID-19 Antigen Detection Kit","manufacturer":{"id_manufacturer":"1074","name":"New Gene (Hangzhou) Bioengineering Co. 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Please visit the following links, and search search \u201cNew Gene\u201d in their whitelists for more information. (Germany) https:\/\/antigentest.bfarm.de\/ords\/f?p=110:100:17097377707548 (France) https:\/\/covid-19.sante.gouv.fr\/tests (Belgium)https:\/\/www.famhp.be\/en\/human_use\/health_products\/medical_devices_accessories\/covid_19\/tests ( Italy) https:\/\/www.salute.gov.it\/interrogazioneDispositivi\/RicercaDispositiviServlet?action=ACTION_MASCHERA (Portugal) https:\/\/www.infarmed.pt\/web\/Infarmed\/pesquisa-dispositivos","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1251","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"0.05","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.87","unit":"%","info":"1 out of 114"},{"parameter":"False negatives","value":"2.02","unit":"%","info":"5 out of 247"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.3","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2303","commercial_name":"COVID-19 Antigen Detection Kit - Nasal Swab (for Self-Test use)","manufacturer":{"id_manufacturer":"1074","name":"New Gene (Hangzhou) Bioengineering Co. 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RT-PCR"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.3","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"92","unit":"%","info":"for Ct <30"},{"parameter":"Clinical Sensitivity","value":"97.5","unit":"%","info":"for CT < 25"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1880","commercial_name":"Ninonasal","manufacturer":{"id_manufacturer":"572","name":"NG Biotech","country":"France","website":"https:\/\/ngbiotech.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal 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variants","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1559","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.51","unit":"%","info":"2 false positive result out of 390 negative samples confirmed by RT-PCR"},{"parameter":"False negatives","value":"2.34","unit":"%","info":"3 false negative results out of 128 positive samples confirmed by RT-PCR"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2281","commercial_name":"Ninonasal-Autotest","manufacturer":{"id_manufacturer":"572","name":"NG Biotech","country":"France","website":"https:\/\/ngbiotech.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Updated list of variants","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1982","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.51","info":"2 false positive result out of 390 negative samples confirmed by RT-PCR)"},{"parameter":"False negatives","value":"2.34","unit":"%","info":"3 false negative results out of 128 positive samples confirmed by RT-PCR"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2250","commercial_name":"Saliva SARS-Cov-2(2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay)","manufacturer":{"id_manufacturer":"1048","name":"Ningbo Beautiful Life Medical Biotechnology Development Co. Ltd.","country":"China","website":"www.nbmlrs.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"The test kit is a rapid chromatographic immunoassay test device based on the principle of sandwich antibody and antigen binding. During testing, SARS-CoV-2 N \/ S antigen, if the virus antigens present in the saliva specimen, it will bind to the antibody conjugates to form a complex. This complex will migrate upward by capillary and then be captured by the immobilized antibody coated at the Test line region (T line) on the NC membrane. A visible black line will show up in the Test line region (T line). The black line will not form in the Test line region (T line) if there is no virus antigen in the sample.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1951","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"2","performances":[{"parameter":"LOD","value":"125","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"12.12","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.09","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.38","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"296","commercial_name":"SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method)","manufacturer":{"id_manufacturer":"187","name":"Ningbo Health Gene Technologies Co. Ltd.","country":"China","website":"www.healthgenetech.net\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"244","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2021","commercial_name":"SARS-oV- Antigen Rapid Test kit (Saliva Test)","manufacturer":{"id_manufacturer":"929","name":"Ningbo Home Test Bio-echnology Co. Ltd.","country":"China","website":"http:\/\/www.nbhtbio.cn\/List-how1-d-01.html"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"The product has passed the PEI review.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1699","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Chromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"500","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4","unit":"AU"},{"parameter":"False negatives","value":"5","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"97.92","unit":"%"},{"parameter":"Clinical Specificity","value":"98.34","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"4049","commercial_name":"SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"1388","name":"NINGBO LVTANG BIOTECHNOLOGY Co. Ltd.","country":"China","website":"www.lvtangbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["non-structural protein NSP1","non-structural protein NSP10","non-structural protein NSP12","non-structural protein NSP13","non-structural protein NSP14","non-structural protein NSP15","non-structural protein NSP16","non-structural protein NSP2","non-structural protein NSP3","non-structural protein NSP4","non-structural protein NSP5","non-structural protein NSP6","non-structural protein NSP7","non-structural protein NSP8","non-structural protein NSP9","nucleocapsid protein"],"last_updated":"2022-09-20 12:46:21 CET","testList":[{"id_test":"5461","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"350","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"97.97","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.3","unit":"%"},{"parameter":"False negatives","value":"4.5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.8","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.5","unit":"%"},{"parameter":"Clinical Specificity","value":"98.7","unit":"%"}]}]},{"id_device":"793","commercial_name":"pGOLD COVID-19 IgG\/IgM\/IgA Microarray Test","manufacturer":{"id_manufacturer":"188","name":"Nirmidas Biotech Inc.","country":"United States","website":"www.nirmidas.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Antibody","IgG","IgM","IgA"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"  Information provided by the manufacturer","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"636","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"   ","performances":[{"parameter":"LOD","value":"1.6","unit":"ng\/mL"}]}]},{"id_device":"297","commercial_name":"Rapid COVID-19 (SARS-CoV-2) IgM\/IgG Antibody Detection Kit","manufacturer":{"id_manufacturer":"188","name":"Nirmidas Biotech Inc.","country":"United States","website":"www.nirmidas.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"245","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"298","commercial_name":"2019-nCoV TaqMan RT-PCR Kit (Catalog# TM67100)","manufacturer":{"id_manufacturer":"189","name":"Norgen Biotek Corp.","country":"Canada","website":"norgenbiotek.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"246","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"1158","commercial_name":"2019-nCoV TaqMan RT-PCR Kit Dx (DxTM67100)","manufacturer":{"id_manufacturer":"189","name":"Norgen Biotek Corp.","country":"Canada","website":"norgenbiotek.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"  https:\/\/norgenbiotek.com\/product\/2019-ncov-taqman-rt-pcr-kit-dx","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"940","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"45","notes":" Information provided by the manufacturer: 2019-nCoV TaqMan RT-PCR Kit Dx provides SARS-CoV-2 detection based on the assays and protocols developed by the CDC. The kit utilizes RT-PCR for the amplification of specific target sequences and target specific probes for the detection of the amplified cDNA. The Primer & Probe Mixes contain all 3 CDC developed assays in individual tubes where probes are labelled with the fluorophore FAM. All assays are premixed to the working concentrations recommended by the CDC. The Positive Control contains two nCoV nucleocapsid target gene RNA (N1 and N2) and RNase P (internal control). The kit contains a positive control to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The 2019-nCoV TaqMan RT-PCR Kit Dx comprises Master Mix for the target and PCR control detection, 3 target Primer & Probe Mixes, as well as a positive control and a negative control (nuclease-free water) to confirm the integrity of the kit reagents. ","performances":[{"parameter":"LOD","value":"10","unit":"virus-copies"},{"parameter":"Positive control","info":"contains the CDC 2019-nCoV markers (N1 and N2) and RNase P gene "},{"parameter":"Negative control","info":"Nuclease-free water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"1160","commercial_name":"COVID19 TaqMan RT-PCR Kit Dx (E-RdRP genes) (DxTM67200)","manufacturer":{"id_manufacturer":"189","name":"Norgen Biotek Corp.","country":"Canada","website":"norgenbiotek.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"941","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"45","notes":" Information provided by the manufacturer: COVID-19 TaqMan RT-PCR Kit (E\/RdRP genes) Dx kit is a multiplexed assay designed for simple, reliable and rapid qualitative detection of SARS-CoV-2 specific RNA using TaqMan  technology (FAM and HEX\/VIC). The kit includes 2x One-Step RT-PCR Master Mix and 2 primer\/probe mixes, a positive control and a negative control (nuclease-free water). The first primer\/probe mix is the E gene\/RP that targets the SARS-CoV-2 \u2013 specific Envelop gene (E gene - FAM) in addition to the human RNase P transcript (RP - HEX\/VIC) as an internal control target to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The second Primer\/Probe Mix is for the RdRP gene and detects two RNA-dependent RNA Polymerase (RdRP) targets where the first RdRP target is SARS-CoV-2 specific (FAM) while the second RdRP target is to detect SARS-CoV and bat-SARS-related CoVs (HEX). The use of the second RdRP gene Primer\/Probe Mix is only required as a discriminatory\/confirmatory step with samples showing positive amplification of the E gene. The provided E gene\/RdRP\/RP Positive Control contains an in vitro RNA transcript for the three SARS-related target genes: E gene, RdRP gene as well as the human RP (internal control).","performances":[{"parameter":"LOD","value":"10","unit":"virus-copies"},{"parameter":"Positive control","info":"The positive control contains the SARS-CoV-2 E gene, RdRP gene and RNase P RNA fragments"},{"parameter":"Negative control","info":"Nuclease-free water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"1176","commercial_name":"Saliva \/ Swab RNA Purification Kit Dx (Cat#Dx69100)","manufacturer":{"id_manufacturer":"189","name":"Norgen Biotek Corp.","country":"Canada","website":"norgenbiotek.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other"],"target_type":["Nucleic acid"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"  https:\/\/norgenbiotek.com\/product\/saliva-swab-rna-purification-kit-dx","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"958","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"Information provided by the manufacturer: Norgen\u2019s Saliva\/Swab RNA Purification Kit Dx provides a rapid method for the purification of total RNA from non-preserved saliva and nasal\/throat swabs, and from preserved saliva collected on Norgen\u2019s Saliva RNA Collection and Preservation Devices Dx (Cat. 53800) or preserved swabs collected in Norgen\u2019s Total Nucleic Acid Preservative Tubes Dx (Cat. Dx69200). Purification is based on using Norgen\u2019s proprietary resin separation matrix. RNA is preferentially purified from other cellular components such as proteins, without the use of phenol or chloroform. The chemistry employed in the kit allows the purification of total RNA, including viral and bacterial RNA, irrespective of size or GC content. The purified RNA is ideal for in vitro diagnostic use for medical purposes.  This kit is optimized to be used with any downstream application employing enzymatic amplification or other enzymatic modifications of RNA followed by signal detection or amplification. Any diagnostic results generated using the RNA isolated with Norgen\u2019s Saliva ","performances":[]}]},{"id_device":"1174","commercial_name":"Saliva RNA Collection and Preservation Devices Dx (Cat#53800)","manufacturer":{"id_manufacturer":"189","name":"Norgen Biotek Corp.","country":"Canada","website":"norgenbiotek.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"  https:\/\/norgenbiotek.com\/product\/saliva-rna-collection-and-preservation-devices-dx-0","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"955","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" Information provided by the manufacturer: Norgen\u2019s Saliva RNA Collection and Preservation Devices Dx are designed for 1) safe and non-invasive saliva collection and 2) preservation of RNA in saliva samples at ambient temperature. Each of the 50 Saliva RNA Collection and Preservation Devices Dx consists of 3 components: (1) Saliva Collection Funnel and Collection Tube, (2) Collection Tube Cap, and (3) Norgen\u2019s Saliva RNA Preservative contained within a sealed squeezable ampoule. After collecting the required volume of saliva the Collection Funnel is removed and the contents of the Preservative Ampoule are then added and mixed with the collected saliva. The Saliva Collection Tube is subsequently sent to the laboratory for RNA isolation and analysis. Each of Norgen\u2019s Collection Tubes is labeled with a unique serial number that can be used for secure and anonymous tracking of the sample. The saliva RNA in preserved samples is stable for up to 2 months at room temperature. This kit is ideal for collecting and preserving RNA samples for in vitro diagnostic use for medical purposes.Norgen\u2019s Saliva RNA Collection and Preservation Devices Dx do not provide a diagnostic result. It is the sole responsibility of the user to use and validate these devices in conjunction with a downstream in vitro diagnostic assay.","performances":[]}]},{"id_device":"1177","commercial_name":"Saliva\/Swab RNA Purification 96-Well Kit Dx (Cat#Dx69300)","manufacturer":{"id_manufacturer":"189","name":"Norgen Biotek Corp.","country":"Canada","website":"norgenbiotek.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other"],"target_type":["Nucleic acid"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"  https:\/\/norgenbiotek.com\/product\/salivaswab-rna-purification-96-well-kit-dx","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"959","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" Information provided by the manufacturer: Norgen\u2019s Saliva\/Swab RNA Purification 96-Well Kit Dx provides a rapid high throughput method for the purification of total RNA from non-preserved saliva and nasal\/throat swabs, and from preserved saliva collected on Norgen\u2019s Saliva RNA Collection and Preservation Devices Dx (Cat. 53800) or preserved swabs collected in Norgen\u2019s Total Nucleic Acid Preservative Tubes Dx (Cat. Dx69200). Purification is based on using Norgen\u2019s proprietary resin separation matrix. RNA is preferentially purified from other cellular components such as proteins, without the use of phenol or chloroform. The chemistry employed in the kit allows the purification of total RNA, including viral and bacterial RNA, irrespective of size or GC content. The purified RNA is ideal for in vitro diagnostic use for medical purposes.This kit is optimized to be used with any downstream application employing enzymatic amplification or other enzymatic modifications of RNA followed by signal detection or amplification. Any diagnostic results generated using the RNA isolated with Norgen\u2019s Saliva \/ Swab RNA Purification 96-Well Kit Dx in conjunction with an in vitro diagnostic assay should be interpreted with regard to other clinical or laboratory findings","performances":[]}]},{"id_device":"1175","commercial_name":"Total Nucleic Acid Preservation Tubes Dx (Cat#Dx69200)","manufacturer":{"id_manufacturer":"189","name":"Norgen Biotek Corp.","country":"Canada","website":"norgenbiotek.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"956","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"Norgen\u2019s Total Nucleic Acid Preservation Tubes Dx are designed for ambient preservation and transport of total nucleic acids (DNA and RNA) from samples collected using a swab. The Total Nucleic Acid Preservation Tubes contain Norgen\u2019s Total Nucleic Acid Preservative in a liquid format. The user simply collects the specimen using a sterile nylon flocked swab (not provided), and then transfers the swab into the Total Nucleic Acid Preservative. The Preservative prevents the growth of Gram-negative and Gram-positive bacteria and fungi, and also inactivates viruses allowing the resulting non-infectious samples to be handled and shipped safely. In addition, the Total Nucleic Acid Preservative eliminates the need to immediately process or freeze samples and allows the samples to be shipped to centralized testing facilities at ambient temperatures. The components of the preservative allow DNA samples to be stored at room temperature for over 4 months and RNA samples to be stored at room temperature for over 2 months. This kit is ideal for collecting and preserving nasal and oral swab samples for in vitro diagnostic use for medical purposes","performances":[]}]},{"id_device":"939","commercial_name":"Total RNA Purification Kit Dx (Dx17200)","manufacturer":{"id_manufacturer":"189","name":"Norgen Biotek Corp.","country":"Canada","website":"norgenbiotek.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other"],"target_type":["Other"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"742","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" https:\/\/norgenbiotek.com\/sites\/default\/files\/flyers\/Coronavirus%20Flyer%20v1-min.pdf","performances":[{"parameter":"Type of antigen","info":"SARS-CoV2 recombinant antigen"}]}]},{"id_device":"299","commercial_name":"Novel Coronavirus test","manufacturer":{"id_manufacturer":"190","name":"NorthShore University HealthSystem","country":"United States","website":"www.northshore.org\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"247","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"300","commercial_name":"2019 Novel Coronavirus PCR","manufacturer":{"id_manufacturer":"191","name":"Northwell Health","country":"United States","website":"www.northwell.edu\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"248","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2316","commercial_name":"GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab)","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"The SARS-CoV-2 Ag Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antigens in human swab specimen. Anti-SARS-CoV-2 antibody is coated in the test line region. During testing, SARS-CoV-2 antigens in the specimen react with anti-SARS-CoV-2 antibody-coated particles in the test. The mixture then migrates forward on the membrane by capillary action and reacts with the anti-SARS-CoV-2 antibody in the test line region. If the specimen contains SARS-CoV-2 antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens of SARS-CoV-2, no coloured line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2017","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.006","unit":"AU"},{"parameter":"False negatives","value":"0.066","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.6","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.5","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2324","commercial_name":"GSD NovaLisa\u00ae SARS-CoV-2 (COVID-19) quantitative IgG","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["IgG"],"specimen":["Other biological fluids","Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"notes":"The quantitative or qualitative immunoenzymatic determination of specific antibodies is based on the ELISA (Enzyme-linked Immunosorbent Assay) technique. Microtiterplates are coated with specific antigens to bind corresponding antibodies of the sample. After washing the wells to remove all unbound sample material a horseradish peroxidase (HRP) labelled conjugate is added. This conjugate binds to the captured antibodies. In a second washing step unbound conjugate is removed. The immune complex formed by the bound conjugate is visualized by adding Tetramethylbenzidine (TMB) substrate which gives a blue reaction product. The intensity of this product is proportional to the amount of specific antibodies in the sample. Acidic stopping solution is added to stop the reaction. This produces a yellow endpoint colour. Absorbance at 450\/620 nm is read using an ELISA Microtiterplate reader.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2025","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Quantitative","subclass":"Enzyme-linked","detection_principle":null,"subcategory":null,"time_minutes":"100","performances":[{"parameter":"LOD","value":"3.6","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%","info":"(> 97%)"},{"parameter":"False negatives","value":"0.51","unit":"%","info":"(99.49)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"15","unit":"%","info":"(< 15 %)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97","unit":"%","info":"(> 97% (15 days post symptom onset))"},{"parameter":"Clinical Specificity","value":"99.49","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"940","commercial_name":"GSD NovaPrime SARS-CoV- (COVID-19)","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"745","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"120","notes":" https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-pcr-assay\/gsd-novaprime-sars-cov-2-covid-19-real-time-pcr\/gsd-novaprime-sars-cov-2-covid-19-real-time-pcr\/","performances":[{"parameter":"Negative control","info":"Nuclease-free water"}]}]},{"id_device":"2321","commercial_name":"GSD NovaPrime\u00ae Plus SARS-CoV-2","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual","Semi-automated"],"target_type":null,"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":[],"notes":"The qualitative detection of specific RNA is performed in one-step real-time RT-PCR format, i.e. reverse transcription (RT) and the subsequent PCR take place in one reaction vessel. The isolated RNA is transcribed into cDNA. The specific gene fragments from SARS-CoV-2 E, N and S genes are subsequently amplified by real-time PCR sequence specific primers. Hydrolysis probes, which are connected at one end to a quencher and at the other end with a reporter fluorescent dye (fluorophore) anneal with the amplified DNA. During the extension, the exonuclease activity of the Taq polymerase degrades the hydrolysis probe and separates the fluorophore from the quencher. After excitation, the reporter emits a fluorescent signal that is detected by the optical unit of a real-time PCR instrument. The fluorescence signal increases with the number of amplicons formed. Primers and probes targeting a fragment of the human RNase P gene are included as an internal process control. Detection of the human RNase P gene serves as an internal positive control for monitoring sample quality, RNA extraction, and detection of inhibitors of the PCR reaction.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2022","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"60","performances":[{"parameter":"LOD","value":"3","unit":"AU"},{"parameter":"Positive control","info":"Yes, will be provided within the kit."}]}]},{"id_device":"2322","commercial_name":"GSD NovaType II SARS-CoV-2","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual","Semi-automated"],"target_type":null,"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":[],"notes":"The GSD NovaType II SARS-CoV-2 is a real-time reverse transcription PCR (RT-PCR) assay designed for the simultaneous qualitative detection of the SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) mutations K417N, E484K and N501Y within the spike (S) gene and discrimination of these mutations from the wildtype sequence. Detection of these mutations is intended to aid in the identification of SARS-CoV-2 variants of concern (VOC). Sample material should be genomic RNA extracted from human upper respiratory (nasal wash\/smear, nasopharyngeal wash\/smear, oropharyngeal swab) specimen types that have previously tested positive for SARS-CoV-2 RNA by diagnostic RT-PCR methods e.g. GSD NovaPrime\u00ae SARS-CoV-2 (COVID-19). The GSD NovaType II SARS-CoV-2 is not intended as stand-alone test for diagnosis of SARS-CoV-2 infection and should only be used in conjunction with a SARS-CoV-2 screening RT-PCR assay.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2023","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"60","performances":[{"parameter":"LOD","info":"K417N: 40.08cpr; E484K: 13.44 cpr; N501: 10.08 cpr; N501Y: 13.44 cpr"},{"parameter":"Positive control","info":"Yes, will be provided within the kit."}]}]},{"id_device":"587","commercial_name":"NovaLisa COVID-19 (SARS-CoV-2) IgA","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody","IgA"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"496","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Qualitative","subclass":"Fluorescence","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[{"parameter":"Type of antigen","info":"spike (S1) and nucleocapsid (N)"}]}]},{"id_device":"588","commercial_name":"NovaLisa COVID-19 (SARS-CoV-2) IgG","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody","IgG"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"497","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Fluorescence","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"589","commercial_name":"NovaLisa COVID-19 (SARS-CoV-2) IgM","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody","IgM"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"498","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Fluorescence","detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"819","commercial_name":"NovaLisa SARS-CoV-2 (COVID-19)","manufacturer":{"id_manufacturer":"368","name":"NovaTec Immundiagnostica GmbH","country":"Germany","website":"https:\/\/www.goldstandarddiagnostics.com\/home\/products\/covid-19-elisa-assays\/gsd-sars-cov-2-elisa\/gsd-sars-cov-2-elisa-igg\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody"],"specimen":["Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"675","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Fluorescence","detection_principle":null,"subcategory":null,"time_minutes":"105","performances":[{"parameter":"Clinical Sensitivity","value":"88.9","unit":"%"},{"parameter":"Clinical Specificity","value":"98.3","unit":"%"},{"parameter":"Type of antigen","info":"Recombinant angen"}]}]},{"id_device":"1582","commercial_name":"Diagnostic Kit (Colloidal Gold) for IgG\/IgM Antibody to SARS-CoV-2","manufacturer":{"id_manufacturer":"661","name":"Novatech","country":"Turkey","website":"www.novadiag.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1262","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"95","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"97","unit":"%"},{"parameter":"False negatives","value":"98","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.6","unit":"% IgG"},{"parameter":"Accuracy","value":"88.4","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"71.4","unit":"% IgM"}]}]},{"id_device":"1393","commercial_name":"NOVACHECK Diagnostic kit (collodial gold) for IgG\/IgM Antibody to SARS-CoV-2","manufacturer":{"id_manufacturer":"661","name":"Novatech","country":"Turkey","website":"www.novadiag.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"  https:\/\/www.novadiag.com\/files\/novadiag-katalog-english.pdf","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1159","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"False positives","value":"7.92","unit":"%","info":"16 fake POSITIVE NUMBER OF PATIENTS \/ 202 TOTAL NUMBER OF PATIENTS) * 100: 7.92%"},{"parameter":"False negatives","value":"2.1","unit":"%","info":"8 fake NEGATIVE NUMBER OF PATIENTS \/ 380 TOTAL NUMBER OF PATIENTS) *100: %2.10"},{"parameter":"Accuracy","value":"95.88","unit":"%","info":"95 CI:%93.44-%97.2"},{"parameter":"Clinical Sensitivity","value":"92.08","unit":"%","info":"95 CI:%87.52-%95.07"},{"parameter":"Clinical Specificity","value":"97.89","unit":"%"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"1762","commercial_name":"SARS CoV-2 Antigen Rapid Test","manufacturer":{"id_manufacturer":"661","name":"Novatech","country":"Turkey","website":"www.novadiag.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal 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This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. An antigen is generally detectable in upper respiratory specimen during the acute phase of the infection (within the first 5 to 7 days from symptom onset). 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Concordancia total: 95.1% Concordancia Sensibilidad: 77.5% \u2022 Para Ct\u226430: 96.7% \u2022 Para Ct\u226425: >99.9% Concordancia Especificidad: 100% Ref: Diagn\u00f3stico cl\u00ednico Sensibilidad diagn\u00f3stica: 95.0% Especificidad diagn\u00f3stica: 100%","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1871","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"600","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False 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Double","detection_principle":null,"subcategory":null,"time_minutes":"37","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%","info":"95% CI: 92,7\u2013100,0%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI: 99,1\u2013100,0%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"1200","commercial_name":"VITROS Immunodiagnostic Products SARS-CoV-2 Antigen","manufacturer":{"id_manufacturer":"356","name":"Ortho Clinical Diagnostics","country":"United Kingdom","website":"www.orthoclinicaldiagnostics.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Automated","Lab-based"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"https:\/\/www.orthoclinicaldiagnostics.com\/en-us\/home\/technical-documents","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3480","assay_category":"Immuno-Antigen","rapid_diagnostic":"No","self_test":null,"reader_required":"Yes","method":"CLIA","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Chemiluminescence","subcategory":null,"time_minutes":"48","performances":[{"parameter":"LOD","value":"25","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"CI: 92.0% - 100%"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%","info":"95% CI: 92.2\u201399.4%"},{"parameter":"Clinical Specificity","value":"98.9","unit":"%","info":"95% CI: 96.3-99.9%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1591","commercial_name":"GeneFinder COVID-19 Fast RealAmp Kit","manufacturer":{"id_manufacturer":"702","name":"OSANG Healthcare Co. Ltd.","country":"South Korea","website":"http:\/\/www.osanghc.com\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Sputum"],"pathogen":[],"lineage":[],"target":[],"notes":"Manual NAT","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1271","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"RT-PCR","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"50","notes":"Manual NAT   ","performances":[{"parameter":"LOD","value":"2","unit":"cpm"},{"parameter":"Positive control","info":"Positive Control Reagent"},{"parameter":"Negative control","info":"Negative Control Reagent"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"304","commercial_name":"GeneFinder COVID-19 RealAmp Kit","manufacturer":{"id_manufacturer":"702","name":"OSANG Healthcare Co. Ltd.","country":"South Korea","website":"http:\/\/www.osanghc.com\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"252","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"180","notes":" https:\/\/www.elitechgroup.com\/genefinder-covid-19-realamp-kit","performances":[]}]},{"id_device":"1593","commercial_name":"GeneFinder\u2122 COVID-19 Ag Dipstick","manufacturer":{"id_manufacturer":"702","name":"OSANG Healthcare Co. Ltd.","country":"South Korea","website":"http:\/\/www.osanghc.com\/en"},"ce_marking":"Yes","commercial_status":"In development","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC","Other"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Other"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Nasal Swab -> GeneFinder\u2122 COVID-19 Ag Dipstick Self Test: other linkages detected: BA2.0 (Stealth); antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-175","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3670","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Around 30 pathogens tested and confirmed no cross-reactivity, except SARS-CoV. lineages_performances 1. Positve standard material : 750 TCID50\/mL 2. B.1.1.7 (Alpha) : 750 TCID50\/mL 3. B.1.351 (Beta) : 750 TCID50\/mL 4. B.1.617.2 (Delta) : 750 TCID50\/mL 5.. P.1 (Gamma) : 750 TCID50\/mL 6. B.1.1.529 (Omicron) : 750 TCID50\/mL","performances":[{"parameter":"LOD","value":"750","unit":"TCID50\/ml","info":"Ct Value (RdRP\/S) 27.67"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.04","unit":"%","info":"Predict Positive Value : 98.96%"},{"parameter":"False negatives","value":"0.83","unit":"%","info":"Predict Negative Value : 99.17%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.09","unit":"%","info":"95% CI : 97.89 - 99.61, 545\/550"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"95% CI : 90.16 - 98.43, 96\/100"},{"parameter":"Clinical Specificity","value":"99.78","unit":"%","info":"95% CI : 98.75 - 99.96, 449\/450"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3100","commercial_name":"GeneFinder\u2122 COVID-19 Ag Dipstick Self Test","manufacturer":{"id_manufacturer":"702","name":"OSANG Healthcare Co. Ltd.","country":"South Korea","website":"http:\/\/www.osanghc.com\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Using Dipstick Self test, FIND is providing Osang Healthcare with a support package that following an open call for proposals to accelerate the availability of affordable SARS-CoV-2 self-tests(Nasal swab) in low- and middle-income countries (LMICs)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2806","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"lineages_performances 1. Positve standard material : 750 TCID50\/mL 2. B.1.1.7 (Alpha) : 750 TCID50\/mL 3. B.1.351 (Beta) : 750 TCID50\/mL 4. B.1.617.2 (Delta) : 750 TCID50\/mL 5.. P.1 (Gamma) : 750 TCID50\/mL 6. B.1.1.529 (Omicron) : 750 TCID50\/mL; antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-175; other lineages detected: BA2.0 (Stealth)","performances":[{"parameter":"LOD","value":"750","unit":"TCID50\/ml","info":"RdRP\/S gene : Ct value 27.23"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Predict Postivie Value : 100% (95% CI : 93.79 - 100.00)"},{"parameter":"False negatives","value":"1.68","unit":"%","info":"Predict Negative Value : 98.32% (95% CI : 94.08 - 99.54)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.32","unit":"%","info":"95% CI : 96.25 - 99.88, 146\/147"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.67","unit":"%","info":"95% CI : 83.33 - 99.41, 29\/30"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI : 96.82 - 100.00, 117\/117"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2741","commercial_name":"GeneFinder\u2122 COVID-19 Ag Plus Rapid Test","manufacturer":{"id_manufacturer":"702","name":"OSANG Healthcare Co. Ltd.","country":"South Korea","website":"http:\/\/www.osanghc.com\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Published article 1 : https:\/\/www.mdpi.com\/2075-4418\/12\/5\/1126 - Title : Validation of GeneFinder COVID-19 Ag Plus Rapid Test and Its Potential Utility to Slowing Infection Waves: A Single-Center Laboratory Evaluation Study - Published article 2: - https:\/\/www.mdpi.com\/2673-8112\/2\/3\/16 - Title : BA.1 Omicron Variant of SARS-CoV-2: First Case Reported in Calabria Region, Italy * Clinical Performance 1. Direct Nasopharyngeal Swab (Prospective study) Total : 603 Samples (Positive : 151, Negative : 452) Sensitivity: 96.03% (95% CI 91.55 - 98.53) Specificity: 99.78% (95% CI: 98.77 - 99.96) 2. Direct Oropharyngeal Swab (Prospective study) Total : 544 Samples (Positive : 144, Negative : 400) Sensitivity: 90.28% (95% CI 84.34 - 94.12) Specificity: 100.00% (95% CI: 99.05 - 100.00) 3. Direct Nasal Swab (Prospective study) Total : 170 Samples (Positive : 70, Negative : 100) Sensitivity: 92.86% (95% CI 84.34 - 96.91) Specificity: 100.00% (95% CI: 96.30 - 100.00) 4. Stored swab samples in transport media (Retrospective study) Total : 500Samples (Positive : 100, Negative : 400) Sensitivity: 89.00% (95% CI 81.37 - 93.75) Specificity: 100.00% (95% CI: 99.05 - 100.00)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2446","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"1) Available to detect asymptomatic patients => 90% (63\/70) sensitivity and 100% specificity (28\/28) in brazil clinical study (Total 70 positive patients and 28 negative out of 98 asymptomatic participants); 2) Available to use stored freeze specimens in transport media (UTM\/VTM) : Please refer to manual file. lineages_performances 1. Positve standard material : 750 TCID50\/mL 2. B.1.1.7 (Alpha) : 750 TCID50\/mL 3. B.1.351 (Beta) : 380 TCID50\/mL 4. B.1.617.2 (Delta) : 750 TCID50\/mL 5. P.1 (Gamma) : 750 TCID50\/mL 6. B.1.1.529 (Omicron) : 750 TCID50\/mL. antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-175. Ohter variants detected: BA2 (Stealth)","performances":[{"parameter":"LOD","value":"750","unit":"TCID50\/ml","info":"RdRP\/S gene : Ct value 27.67"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.68","unit":"%","info":"Predict Postivie Value : 99.32% (95% CI : 96.25 - 99.88)"},{"parameter":"False negatives","value":"1.1","unit":"%","info":"Predict Negative Value : 98.69% (95% CI : 97.46 - 99.53)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%","info":"95% CI : 97.85 - 99.54, 597\/603"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.03","info":"95% CI : 91.55% - 98.53%, 146\/151"},{"parameter":"Clinical Specificity","value":"99.78","info":"95% CI : 98.76% - 99.96%, 451\/452"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2806","commercial_name":"GeneFinder\u2122 COVID-19 Ag Self Test","manufacturer":{"id_manufacturer":"702","name":"OSANG Healthcare Co. Ltd.","country":"South Korea","website":"http:\/\/www.osanghc.com\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"MFDS 22-106 approved by Korea FDA A. OI-01SA-SE : CE COC (Certification No. 1434-IVDD-082-2022) B. OI-01SA-SH : FDA EUA (EUA No. 220037) C. G-Tech COVID-19 Ag Rapid Test : ANVISA (No. 0440463227)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2511","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-17; lineages_performances 1. Positve standard material : 750 TCID50\/mL 2. B.1.1.7 (Alpha) : 750 TCID50\/mL 3. B.1.351 (Beta) : 380 TCID50\/mL 4. B.1.617.2 (Delta) : 750 TCID50\/mL 5.. P.1 (Gamma) : 750 TCID50\/mL 6. B.1.1.529 (Omicron) : 750 TCID50\/mL; other lineages detected: BA2.0 (Stealth)","performances":[{"parameter":"LOD","value":"750","unit":"TCID50\/ml","info":"Ct value (RdRP\/S) 27.23"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Predict Postivie Value : 100% (95% CI : 93.79 - 100.00)"},{"parameter":"False negatives","value":"1.68","unit":"%","info":"Predict Negative Value : 98.32% (95% CI : 94.08 - 99.54)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.87","info":"95% CI : 95.97 - 99.69 - (175\/177)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.67","unit":"%","info":"95% CI: 88.64 \u2013 99.08 - (58\/60)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI: 96.82 \u2013 100.00 - (117\/117)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3102","commercial_name":"GeneFinder\u2122 COVID-19 IgG\/IgM Rapid Test","manufacturer":{"id_manufacturer":"702","name":"OSANG Healthcare Co. Ltd.","country":"South Korea","website":"http:\/\/www.osanghc.com\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["Other","spike protein"],"notes":"Published article : Positivity of SARS-CoV-2 Antibodies among Korean Healthy Healthcare Workers 1 and 2 Weeks after Second Dose of Pfizer-BioNTech Vaccination","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2817","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Tested total 20 pathogens (No cross-reactivity : 20, Detected : only SARS-CoV). ","performances":[{"parameter":"LOD","info":"Serum IgG 1\/128 (Dilution rate), IgM 1\/4 (Dilution rate)"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.06","unit":"%","info":"Predict Postivie Value : 96.94% (95% CI : 91.38 - 98.95)"},{"parameter":"False negatives","value":"3.29","unit":"%","info":"Predict Negative Value : 96.71% (95% CI : 92.53 - 98.59)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.8","unit":"%","info":"95% CI: 93.81 - 98.37"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"95% CI: 88.82 - 97.85"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":"95% CI: 94.29 - 99.32"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"3105","commercial_name":"Immuno-on COVID-19 IgG Test","manufacturer":{"id_manufacturer":"702","name":"OSANG Healthcare Co. Ltd.","country":"South Korea","website":"http:\/\/www.osanghc.com\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["spike protein"],"notes":"Semi-qualitative for detection of SARS CoV-2 antibody in human blood","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2811","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":"No","reader_required":"Yes","method":"Immunoassay","measurement":"Semiquantitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"PRNT50 853 (CPE 1280) \/ (Serum, Plasma, Whole blood : 1\/32 Titer)"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"1.94%[Predict Positive Value : 98.06% (95% CI: 93.19 ~ 99.47)]"},{"parameter":"False negatives","info":"1.33%[Predict Negative Value : 98.67% (95% CI: 95.27 ~ 99.63)]"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","info":"98.42% (95% CI: 96.01 - 99.38)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","info":"98.06% (95% CI: 93.19 ~ 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The assay is provided in a multiplex format, which means that one sample from a patient can be analyzed in one tube.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2620","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"RT-PCR","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"80","performances":[{"parameter":"LOD","unit":"cpr","info":"5-20 cpr for N1 and N2 combined depending on the cycler machine"},{"parameter":"Positive control","info":"Positive controls (20 copies\/\u03bcl). 200 \u03bcl should be added during the RNA extraction procedure."},{"parameter":"Negative control","info":"Added to the assay. 200 \u03bcl should be added during the RNA extraction procedure."},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","info":"96 samples per run"}]}]},{"id_device":"309","commercial_name":"PEPperCHIP SARS-CoV-2 Proteome Microarray (manual)","manufacturer":{"id_manufacturer":"198","name":"PEPperPRINT GmbH","country":"Germany","website":"www.pepperprint.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Other"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"255","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":"N.A.","method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":"Manual or automated   ","performances":[{"parameter":"Type of antigen","info":"colloidal gold\u00a0labelled covid antigen"}]}]},{"id_device":"310","commercial_name":"SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)","manufacturer":{"id_manufacturer":"204","name":"PerGrande BioTech Development Co. 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tubes"}]}]},{"id_device":"485","commercial_name":"SARS-CoV-2 Rapid TesIgM\/IgG","manufacturer":{"id_manufacturer":"318","name":"Pharmact (Berlin)","country":"Germany","website":"pharmact-health.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"716","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"Precision","value":"99","unit":"% IgM"},{"parameter":"Precision","value":"99.2","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"98.1","unit":"% IgM"},{"parameter":"Clinical 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CET","testList":[{"id_test":"420","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","notes":"Fingertip","performances":[{"parameter":"Accuracy","value":"99","unit":"% IgM"},{"parameter":"Accuracy","value":"99.2","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"98.1","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"98.2","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.5","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"99.7","unit":"% IgG"}]},{"id_test":"421","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","notes":"Card  ","performances":[{"parameter":"Precision","value":"99","unit":"% IgM"},{"parameter":"Precision","value":"99.2","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"98","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"98.2","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.5","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"99.7","unit":"% IgG"}]}]},{"id_device":"1825","commercial_name":"LAMPIGEN COVID19 RT-LAMP PCR KIT","manufacturer":{"id_manufacturer":"830","name":"Pharmaline AS","country":"Turkey","website":"pharmaline.com.tr\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Nucleic acid"],"specimen":["Anterior nasal swab","Nasal swab","Nasopharyngeal swab","Throat swab"],"pathogen":[],"lineage":[],"target":[],"notes":"INTENDED TO USE LAMPIGEN\u00ae RT-LAMP KIT is a screening assay with Fluorometric detection for SARS-CoV-2 viral RNA. A Point of Care diagnostic solution with Fluorometric RT-LAMP portable devices (Genie\u00ae II, III, and HT). LAMPIGEN\u00ae RT-LAMP KIT does not require RNA extraction and can be used directly on oropharyngeal\/nasopharyngeal swab dilutions. The causative agent of COVID-19, SARS-CoV-2, is an enveloped, positive-sense RNA virus belonging to the Coronaviridae family. Regular and reliable detection of SARS-CoV-2 RNA is required to monitor the spread of the virus and screen clinical samples from patients displaying relevant symptoms of COVID-19. LAMPIGEN\u00ae RT-LAMP KIT is an in-Vitro diagnostic point of care test based on Reverse Transcription Loop-mediated isothermal AMPlification (RT-LAMP) technology for the detection of SARS-CoV-2 viral RNA. The detection is a one-step process, a closed-tube format where the reverse transcription and subsequent amplification of the specific target sequence occur in the same reaction well. The processing detects the amplified outcome in real-time using fluorescence exposure. It automatically runs an anneal curve at the end of amplification, where the reaction is heated to 98\u00b0C and slowly cooled. This final step acts as a secondary confirmatory check - ensuring LAMP amplicons are specific to SARS-CoV-2. The result is exact, and it reports automatically a positive (+) from both the amplification timeslot and the annealing temperature at which the test detects the virus","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1502","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"LAMP","measurement":null,"subclass":"Fluorescence","detection_principle":null,"subcategory":null,"time_minutes":"30","notes":"Transcription Loop-mediated isothermal AMPlification (RT-LAMP) ","performances":[{"parameter":"LOD","value":"3","unit":"cpu"},{"parameter":"Positive control","info":"yes"},{"parameter":"Negative control","info":"yes"},{"parameter":"Analytical Sensitivity","value":"99","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1823","commercial_name":"RAPIDIGEN COVID19 AG IMMUNOASSAY","manufacturer":{"id_manufacturer":"830","name":"Pharmaline AS","country":"Turkey","website":"pharmaline.com.tr\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Throat swab"],"pathogen":[],"lineage":[],"target":[],"notes":"1. Product Information Product Name COVID-19 Ag Test Trade Name Rapidigen Product Code PHRPD 2020 Manufacturer Pharmaline Saglik Hizmetleri Ticaret A.S. Address Headquarter: Atat\u00fcrk Caddesi, Atat\u00fcrk Caddesi Konutlari, No: 43 A Blok Daire 6 Sahrayicedit-Kadik\u00f6y, 34734 Istanbul, Turkey. Factory: Bati Sitesi Mah. 2308 Cad. Gersan Sit. No.: 52, Yenimahalle, Ankara, Turkey. 2. Product Description Single-use cassette test for professional in vitro diagnostic usage. 3. Classification according to 98\/79\/EC In-vitro Diagnostic Medical Devices Professional Use IVD, 98\/79\/EC. 4. Intended Use Rapidigen COVID-19 Ag Test is used for in vitro qualitative detection of novel coronavirus antigen in human throat swabs or nasal swabs. 5. Sample Type Human throat or nasal swab. 6. Reagents This test included 2019- nCoV antibody, anti-chicken IgY polyclonal antibody, chicken IgY and colloidal gold conjugate. 7. Analysis Method Rapidigen COVID-19 Ag Test is a rapid, qualitative, immunochromatographic assay for detecting the 2019-nCoV antigen in human oropharyngeal or nasopharyngeal swabs. The sample will be under the capillary action to move forward along the test cassette when it contains a new antigen crown at a detectable level. The antigens with colloidal gold labeling are coronavirus monoclonal antigens\u2014the complex immune fixes on the membrane. If the coronavirus monoclonal antibody forms the colored line, the visualization is positive for the coronavirus antigen; If the line does not show color, the result is negative. A colored line will always appear in the control line region, indicating that the proper specimen volume has been added and membrane wicking has occurred. 8. Performance Evaluation Rapidigen COVID-19 Ag Test has been evaluated using clinical samples. PCR methods are used to compare Rapidigen COVID- 19 Ag Test, and the following results are obtained. \u2003 8.1. Sensitivity & Specificity Rapidigen COVID - 19 Ag Test PCR Test Total Positive Negative Positive 164 3 167 Negative 12 438 450 Total 176 441 617 Analysis of coincidence rate of Rapidigen COVID-19 Ag Test and PCR Test in nasal samples: Sensitivity: 164\/ (164+12) \u00d7 100% = 93.18% Specificity: 438 \/ (3+438) \u00d7 100% = 99.32% Accuracy: (164+438) \/ (164+12+3+438) \u00d7 100% = 97.57% 8.2. Interferences Samples containing Mucin, Hemoglobin, Histamine Hydrochloride, Human albumin, \u03b1- interferon, Lopinavir, Tobramycin, Ribavirin, Tramadol, Azithromycin, Meropenem, Oseltamivir, Benzocaine, Peramivir in different concentrations do not affect the test result. Test results present no interference. 8.3. Cross-Reactivity This product does not cross-react with pathogens of HKU1, OC43, NL63, 229E, MERS Coronavirus, Human Metapneumovirus, Influenza A virus H1N1, Influenza A virus H3N2, Influenza A virus H5N1, Influenza A virus H7N9, Influenza B virus, Mycoplasma pneumonia, Rhinovirus A, Rhinovirus B, Rhinovirus C, Staphylococcus aureus, Adenovirus 1, Adenovirus 2, Adenovirus 3, Adenovirus 4, Adenovirus 5, Adenovirus 7, Adenovirus 55, Enterovirus A, Enterovirus B, Enterovirus C, Enterovirus D, EB Virus, Measles virus, Human cytomegalovirus, Rotavirus, Norovirus, Mumps virus, Varicella-zoster virus, Respiratory syncytial virus, Mycoplasma pneumonia, and Escherichia Coli. 9. Packaging Consumer package includes: a) Primary package: An aluminum pouch including test cassette and silica gel. b) Secondary package: Carton box including tests in aluminum pouches, sterile swab, sample extraction tube, extraction tube tips, extraction reagent (R), workstation and instructions for use sheet. Packing instructions, labeling and symbols are prepared according to the 98\/79\/EC in-vitro diagnostic medical device directive, harmonized standards. c) The transportation package is a carton package covered with strong nylon film to provide extra protection for the products during transportation and storage. 10. Kit components Test cassettes, sterile swab, sample extraction tube, extraction tube tips, extraction reagent (R), workstation and instructions for use. 11. Storage & Shelf Life Store at 4 - 30\u00b0C (39 - 86\u00b0F); maximum 24 months 12. Transportation Truck or aircraft freight. Transport conditions should be between 4-30\u00b0C (39 - 86\u00b0F).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1501","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Magnetic Electrochemical","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"30","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Sample contamination or not following the IFU protocol"},{"parameter":"False negatives","info":"Sample contamination or not following the IFU protocol"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"}]}]},{"id_device":"1447","commercial_name":"FOAMING TEST","manufacturer":{"id_manufacturer":"674","name":"PharmaNona","country":"Turkey","website":"www.foamingtest.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1197","assay_category":"Nucleic acid-Other","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"1","performances":[{"parameter":"Positive control","value":"89","unit":"AU"},{"parameter":"Negative control","value":"92","unit":"AU"},{"parameter":"Analytical Sensitivity","value":"92","unit":"%"},{"parameter":"Analytical Specificity","value":"92","unit":"%"},{"parameter":"Clinical Sensitivity","value":"92","unit":"%"},{"parameter":"Clinical Specificity","value":"92","unit":"%"},{"parameter":"Throughput","info":"single tubes"}]}]},{"id_device":"686","commercial_name":"COVID19 IgG\/IgM Rapid Test","manufacturer":{"id_manufacturer":"557","name":"Pharmatech","country":"United States","website":"www.phamatech.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"811","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Accuracy","value":"92.9","unit":"% IgM"},{"parameter":"Accuracy","value":"98.6","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"85","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"96","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"98","unit":"% IgG"}]}]},{"id_device":"3150","commercial_name":"INDICAID COVID-19 Rapid Antigen Self-Test","manufacturer":{"id_manufacturer":"1339","name":"PHASE Scientific International Limited","country":"Hong Kong S.A.R","website":"www.phasescientific.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"The INDICAID\u00ae COVID-19 Antigen Self-Test is a rapid lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is intended for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 or older with or without symptoms or other epidemiological reasons to suspect COVID-19. This test is also intended for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individual aged 2 years or older with or without symptoms or other epidemiological reasons to suspect COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2858","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"2800","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False 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sample; Sensitivity limit: 500copies\/ml; coincidence rate of Positive reference: 98%; Coincidence rate ofNegativereference: 100%; Precision: CV% ?5%. https:\/\/f95fa0e3-ef79-4e7f-a6df-88d8f019025a.filesusr.com\/ugd\/ca8cd1_d64bc7a5da794aa5be81bcc37b468717.pdf","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"853","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" https:\/\/f95fa0e3-ef79-4e7f-a6df-88d8f019025a.filesusr.com\/ugd\/ca8cd1_d64bc7a5da794aa5be81bcc37b468717.pdf","performances":[{"parameter":"LOD","value":"500","unit":"cpm"},{"parameter":"Positive control","info":"SARS-CoV-2 ORF1ab and Nucleoprotein gene"},{"parameter":"Negative control","info":"RNase-free and nuclease-free distilled 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Professional Rapid Test was tested with the following viral strains, no cross-reaction was observed at the following concentrations: - MERS 1.17x10^5 TCID50\/mL - NL63 4.68x10^4 TCID50\/mL - OC43 5.01x10^5 TCID50\/mL - 229E 1.41x10^5 TCID50\/mL - Adenovirus 7A (species B) 1.02x10^8 TCID50\/mL - Parainfluenza Virus Type 1 9.12x10^8 TCID50\/mL - Parainfluenza Virus Type 2 4.17x10^5 TCID50\/mL - Parainfluenza Virus Type 3 2.57x10^8 TCID50\/mL - Parainfluenza Virus Type 4 1.41x10^5 TCID50\/mL - Rhinovirus 1A 1.70x10^5 TCID50\/mL - Influenza A H1N1 New Caledonia\/20\/99 4.17x10^5 TCID50\/mL - Influenza B Florida\/02\/06 4.68x10^4 TCID50\/mL - Respiratory Syncytial Virus Type B (RSV-B) CH93-18(18) 1.55x10^4 TCID50\/mL - Enterovirus Type 71 2003 Isolate (cell line LLC-mk2) 1x10^5.86 TCID50\/mL - Human Metapneuomovirus 16 (hMPV-16) Type A1 IA10-2003 3.8x10^6 TCID50\/mL - Recombinant Nucleocapsid SARS-CoV (2003) 1.24 mg\/mL","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2391","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"102000","unit":"TCID50\/ml","info":"600 pg\/mL of recombinant nucleocapsid protein"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"N.A."},{"parameter":"False negatives","info":"N.A."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.1","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.3","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2685","commercial_name":"COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1228","name":"PRIMA Lab SA","country":"Switzerland","website":"https:\/\/primahometest.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"COVID-19 ANTIGEN RAPID TEST was tested with the following viral strains, no cross-reaction was observed at the following concentrations: Adenovirus type 3 3.16 x 10^4 TCID50\/ml Influenza B 3.16 x 10^6 TCID50\/ml Adenovirus type 7 1.58 x 10^5 TCID50\/ml Human Rhinovirus 2 2.81 x 10^4 TCID50\/ml Human Coronavirus OC43 1 x 10^6 TCID50\/ml Human Rhinovirus 14 1.58 x 10^6 TCID50\/ml Human Coronavirus 229E 5 x 10^5 TICID50\/ml Human Rhinovirus 16 8.89 x 10^6 TCID50\/ml Human Coronavirus NL63 1 x 10^6 TICID50\/ml Masern-Virus 1.58 x 10^4 TCID50\/ml Human Coronavirus HKU1 1 x 10^6 TICID50\/ml Mumps-Virus 1.58 x 10^4 TCID50\/ml MERS COV Florida 1.17 x 10^4 TICID50\/ml Parainfluenza virus 2 1.58 x 10^7 TCID50\/ml Influenza A H1N1 3.16 x 10^5 TCID50\/ml Parainfluenza virus 3 1.58 x 10^8 TCID50\/ml Influenza A H3N2 1 x 10^5 TCID50\/ml Respiratory syncytial virus 8.89 x 10^4 TCID50\/ml Hangzhou Alltest Biotech CO., Ltd is the contract OEM manufacturer of COVID-19 Antigen Rapid Test which is already on the Common list of rapid antigen tests (JRC Device ID 1257).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2390","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"N.A."},{"parameter":"False negatives","info":"N.A."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.6","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1975","commercial_name":"COVID-19 IgG Spike Self Test","manufacturer":{"id_manufacturer":"808","name":"PRIMA Lab SA","country":"Switzerland","website":"primahometest.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["IgG"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The performance of the device to recognize IgG post-Vaccination have been clinically evaluated. The EC mark for self testing is available (approved by Notified Body 0483)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1651","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"93.75","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Possible cross-interferences were observed: Ad V IgG, Ad V IgM, RF IgG, antinuclear Ab, HCV IgG"},{"parameter":"False negatives","info":"No hook effect has been observed"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.5","unit":"% IgG","info":"After infection 96.5% (Wilson 95% Cl: 94.9%-98.13%), after vaccination > 98% at 35 days, C.I. 95%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.6","unit":"% IgG","info":"Sensitivity after infection 92.6%(sensitivity after vaccination 98.3% at 35 days, C.I. 95%)"},{"parameter":"Clinical Specificity","value":"97.4","unit":"% IgG","info":"on pre-outbreak samples 97.4% (C.I. 95%)"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1875","commercial_name":"COVID-19 NEUTRALISING Ab RAPID TEST","manufacturer":{"id_manufacturer":"808","name":"PRIMA Lab SA","country":"Switzerland","website":"primahometest.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The performance of the device to recognize IgG post-Vaccination have been clinically evaluated.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1556","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"93.75","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Possible cross-interferences were observed: Ad V IgG, Ad V IgM, RF IgG, antinuclear Ab, HCV IgG"},{"parameter":"False negatives","info":"No hook effect has been observed"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.5","unit":"% IgG","info":"After infection 96.5 % (Wilson 95% Cl: 94.9%-98.13%), after vaccination > 98% at 35 days, C.I. 95%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.6","unit":"% IgG","info":"Sensitivity after infection 92.6%(sensitivity after vaccination 98.3% at 35 days, C.I. 95%)"},{"parameter":"Clinical Specificity","value":"97.4","unit":"% IgG","info":"Specificity on pre-outbreak samples 97.4% (C.I. 95%)"}]}]},{"id_device":"318","commercial_name":"PRIMA COVID-19 IgG\/IgM Rapid Test (For Professional Use)","manufacturer":{"id_manufacturer":"808","name":"PRIMA Lab SA","country":"Switzerland","website":"primahometest.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"266","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"Type of antigen","info":"Nucleocapsid (N) antigen\u00a0"}]}]},{"id_device":"321","commercial_name":"P4DETECT COVID-19 Ag","manufacturer":{"id_manufacturer":"1349","name":"PRIME4DIA Co. 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In this test, antibody specific to the SARS-CoV-2 antigen is separately coated on the test line regions of the test device. During testing, the extracted specimen reacts with the antibody to SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibody to SARS-CoV-2 on the membrane and generate one colored lines in the test regions. If SARS-CoV-2 antigens are present in the specimen a colored test line would be visible in the result window. If SARS-CoV-2 antigens are not present in the specimen, then no color appears in the test line.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"269","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"800","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"AU"},{"parameter":"False negatives","value":"3.3","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.33","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.67","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"320","commercial_name":"P4DETECT COVID-19 IgM\/IgG","manufacturer":{"id_manufacturer":"208","name":"PRIME4DIA Co. 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Ltd.","country":"South Korea","website":"https:\/\/prime4dia.com\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":null,"pathogen":[],"lineage":[],"target":["spike protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"267","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[{"parameter":"Type of antigen","info":"S1 domain of the spike protein"}]}]},{"id_device":"3103","commercial_name":"Q-Sens\u00ae COVID-19 Ag","manufacturer":{"id_manufacturer":"208","name":"PRIME4DIA Co. Ltd.","country":"South Korea","website":"https:\/\/prime4dia.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Distributor : Dx&Vx Co.,Ltd.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2809","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"800","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"AU"},{"parameter":"False negatives","value":"3.3","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.33","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.67","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2782","commercial_name":"PathFlow\u2122 COVID-19 Rapid Antigen PRO","manufacturer":{"id_manufacturer":"17293","name":"Primer Design Limited","country":"United Kingdom","website":"https:\/\/novacyt.com\/product\/pathflow-covid-19-rapid-antigen-test-pro\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"None","last_updated":"2023-03-30 10:57:26 CET","testList":[{"id_test":"21026","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Enzyme-linked","detection_principle":"Absorbance","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"97.6","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Analytical Specificity","value":"99.7","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Analytical Specificity","value":"99.9","unit":"%","info":"Nasal swab"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU","info":"Nasal swab"},{"parameter":"False negatives","value":"8","unit":"AU","info":"Nasal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%","info":">99%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.5","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%","info":"Nasal swab"}]}]},{"id_device":"25543","commercial_name":"PathFlow\u2122 COVID-19 Rapid Antigen PRO","manufacturer":{"id_manufacturer":"17298","name":"Primer Design Limited","country":"United Kingdom","website":"https:\/\/novacyt.com\/product\/pathflow-covid-19-rapid-antigen-test-pro\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal 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Specificity","value":"99.7","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Analytical Specificity","value":"99.9","unit":"%","info":"Nasal swab"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU","info":"Nasal swab"},{"parameter":"False negatives","value":"8","unit":"AU","info":"Nasal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%","info":">99%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.5","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%","info":"Nasal swab"}]}]},{"id_device":"1156","commercial_name":"genesig(R) Coronavirus (COVID-19) Rt-PCR assay","manufacturer":{"id_manufacturer":"606","name":"Primerdesign Novacyt","country":"United Kingdom","website":"www.primerdesign.co.uk"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Saliva","Sputum"],"pathogen":[],"lineage":[],"target":[],"notes":"A real-time PCR assay for the specific and exclusive detection of SARS-CoV-2 from human nasopharyngeal swabs, oropharyngeal swabs, sputum, raw saliva and preserved saliva specimens. 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The product is to be operated by a trained Healthcare Professional (HCP); however, the ThEA product does not require any laboratory infrastructure or additional equipment and can be used at the point of care or near point-of-care. The ThEA product introduces a unique advantage of eliminating the need for biochemical reagents or any system calibration or control sample. The ThEA product utilizes a disposable diagnostic sensor stick to which the sample is applied using the swab. The measurement is done using ThEA RapiDx THz analyzer, and the process takes less than 30 seconds. The entire process from sample collection to results is achieved within two minutes. 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Closed units with saliva collection and vials and container solution.","last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"2253","assay_category":"Unknown","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"LAMP","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"40","performances":[{"parameter":"LOD","value":"40","unit":"cpu"},{"parameter":"Positive control","info":"Yes"},{"parameter":"Negative control","info":"Yes"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"93.75","unit":"%"},{"parameter":"Clinical Specificity","value":"99.95","unit":"%"}]}]},{"id_device":"5812","commercial_name":"SARS-CoV-2 Antigen Rapid Test  (Nasal Swab)","manufacturer":{"id_manufacturer":"1375","name":"Rapid Labs Ltd.","country":"United Kingdom","website":"www.rapidlabs.co.uk"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Mumps Virus (MuV)","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a rapid chromatographic immunoassay  for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasal swab \r\nspecimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole \r\nbasis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. \r\nNegative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2023-01-09 10:03:34 CET","testList":[{"id_test":"20273","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"95.3","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.047","unit":"AU"},{"parameter":"False negatives","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.7","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.3","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"3096","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"1375","name":"Rapid Labs Ltd.","country":"United Kingdom","website":"www.rapidlabs.co.uk"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. 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The test is intended for professional use only.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1991","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"950","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4","unit":"AU"},{"parameter":"False negatives","value":"3","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.7","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.1","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1962","commercial_name":"BIOCREDIT COVID-19 Ag","manufacturer":{"id_manufacturer":"220","name":"RapiGEN Inc.","country":"South Korea","website":"www.rapigen-inc.com\/eng"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"BIOCREDIT COVID-19 Ag is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in human nasopharynx. This test is for in-vitro professional diagnostic use and intended as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms. It provides only an initial screening test result and more specific alternative diagnosis methods should be performed in order to confirm COVID-19 infection. BIOCREDIT COVID-19 Ag has been evaluated with clinical nasopharyngeal specimens which were identified with the RT-PCR test in Korea and Romania.","last_updated":"2022-10-05 14:00:56 CET","testList":[{"id_test":"3931","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"562","unit":"PFU\/mL"}]}]},{"id_device":"1606","commercial_name":"BIOCREDIT COVID-19 Ag - SARS-CoV 2 Antigen test","manufacturer":{"id_manufacturer":"220","name":"RapiGEN Inc.","country":"South Korea","website":"www.rapigen-inc.com\/eng"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":null,"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"1287","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"Clinical Sensitivity","value":"90.2","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1963","commercial_name":"BIOCREDIT COVID-19 Ag Test Nasal","manufacturer":{"id_manufacturer":"220","name":"RapiGEN Inc.","country":"South Korea","website":"www.rapigen-inc.com\/eng"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"BIOCREDIT COVID-19 Ag Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in human nasal specimen. 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This study was conducted by 8 intended users at 4 near patient testing clinical sites. Patients above 14 years of age visiting the study sites seeking testing and presenting symptoms suggestive of upper respiratory infections consistent with COVID 19 or influenza were approached to participate in the study, and those beyond 7 days since the onset of symptoms were excluded. 2 nasopharyngeal swabs were collected from each study participant. In a randomized manner, 1 swab was tested immediately at the study site using the SARS CoV 2 & Flu A\/B Rapid Antigen Test, and the other was sent to a central laboratory for testing using a highly sensitive US FDA approved multiplex RT PCR method as the comparator. 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105"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"not applicable for rapid tests"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.24","unit":"%","info":"For ct \u2264 30"},{"parameter":"Clinical Specificity","value":"99.35","unit":"%"}]}]},{"id_device":"2323","commercial_name":"SARS-CoV-2 Antigen Self Test Nasal","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal 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30)"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":" (overall cohort)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1604","commercial_name":"SARS-CoV-2 Rapid Antigen Test","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1285","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Clinical Sensitivity","value":"96.52","unit":"%"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%"},{"parameter":"Type of antigen","info":"nucleocapside protein"}]}]},{"id_device":"25546","commercial_name":"SARS-CoV-2 Rapid Antigen Test 2.0 ","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["SARS-CoV","SARS-CoV-2"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"last_updated":"2023-03-31 17:45:26 CET","testList":[{"id_test":"21059","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"14.6","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%","info":"Refers to the LoD and analytical studies"},{"parameter":"Analytical Specificity","value":"100","unit":"%","info":"Refers to the analytical studies"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"tests","info":"1 out of 402"},{"parameter":"False negatives","value":"1","unit":"tests","info":"1 out of 100"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"Not applicable for rapid tests"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%","info":"Overall Ct values"},{"parameter":"Clinical Specificity","value":"99.75","unit":"%","info":"Overall Ct values"}]}]},{"id_device":"5839","commercial_name":"SARS-CoV-2 Rapid Antigen Test 2.0 Nasal","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV","SARS-CoV-2"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"In addition to the validation studies listed in the Instructions for Use (IFU), this product was evaluated independently in a study conducted by investigators at the Technical University of Munich and the Institute of Virology at Helmholtz Munich. This  study  prospectively enrolled 428  healthcare  workers  from  the University Hospital Munich Rechts der Isar of the Technical University of Munich who either reported recent onset of COVID-19 associated symptoms or completed routine diagnostic testing between 24th of May and 22nd of September 2022. Rapid test performance was compared to the standard-of-care RT-PCR results at the hospital, which was also calibrated to report viral load in genomic copies (GE) \/ ml. All samples with a viral load above 9.5x104 GE\/ml were sequenced, and results revealed a majority of infections with BA.5 followed by BA.2 and BA.4. In the entire cohort, the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal demonstrated a sensitivity of 89.4% and a specificity of 99.4%. ","last_updated":"2023-01-24 10:04:16 CET","testList":[{"id_test":"5447","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"13","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%","info":"With reference to the LoD and analytical studies"},{"parameter":"Analytical Specificity","value":"100","unit":"%","info":"With reference to the analytical studies"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"tests","info":"0\/487"},{"parameter":"False negatives","value":"6","unit":"tests","info":"6\/143"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.15","unit":"%","info":"For ct\u226430"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2228","commercial_name":"SARS-CoV-2 Rapid Antigen Test Nasal","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Rapid Antigen Test Nasal is technically identical to the nasopharyngeal test launched in 2020 (SARS-CoV-2 Rapid Antigen Test), which is already included in the EU common list of COVID-19 rapid antigen tests.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1929","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"146.6","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.91","unit":"%","info":"5 false positives out of 546 PCR negative samples."},{"parameter":"False negatives","value":"10.68","unit":"%","info":"14 false negative results out of 131 PCR-positive samples for Ct \u2264 30"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.5","unit":"%","info":" (95% CI: 93.7 % - 97.0 %)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"89.6","unit":"%","info":" (Ct \u2264 30) and 93.1 % (for Ct below LOD 27)"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2760","commercial_name":"cobas SARS-CoV-2 & Influenza A\/B Nucleic acid test for use on the cobas Liat System","manufacturer":{"id_manufacturer":"221","name":"ROCHE Diagnostics","country":"Germany","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Near POC \/ POC"],"target_type":["Nucleic acid"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Info available upon request.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2465","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[]}]},{"id_device":"339","commercial_name":"cobas SARS-CoV-2 (for use on the cobas 6800\/8800 Systems)","manufacturer":{"id_manufacturer":"221","name":"ROCHE Diagnostics","country":"Germany","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"Info available upon request  ","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"283","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"notes":" https:\/\/diagnostics.roche.com\/global\/en\/products\/params\/cobas-sars-cov-2-test.html","performances":[{"parameter":"Throughput","info":"up to 384\/1056 tests in an 8-hour shift, respectively"}]}]},{"id_device":"2761","commercial_name":"cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System","manufacturer":{"id_manufacturer":"221","name":"ROCHE Diagnostics","country":"Germany","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Near POC \/ POC"],"target_type":["Nucleic acid"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Info available upon request","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2466","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[]}]},{"id_device":"882","commercial_name":"Elecsys\u00ae Anti-SARS-CoV-2","manufacturer":{"id_manufacturer":"221","name":"ROCHE Diagnostics","country":"Germany","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Lab-based"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The Elecsys Anti SARS CoV 2 assay uses a recombinant antigen representing the nucleocapsid (N) protein in a double-antigen sandwich assay format.  OTher pathogens tested for cross-linking Borrelia burgdorferi; E. coli; Neisseria gonorrhoeae; HEV; HTLV; Listeria; Measles; Parvovirus B19; Plasmodium falciparum; Rubella;; Toxoplasma gondii; ","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"696","assay_category":"Immuno-Antibody","rapid_diagnostic":"No","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Chemiluminescence","subcategory":null,"time_minutes":"18","notes":"Preliminary assessment indicates that the mutations within the described variants are not expected to affect the clinical interpretation of samples measured with the Elecsys\u00ae Anti-SARS-CoV-2 S assay.","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.5","unit":"%","info":" (95% CI: 97-100%) (\u226514 days after PCR confirmation)"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%","info":"(95% CI: 99.69-99.88%)"},{"parameter":"Type of antigen","info":"Nucleocapsid N-protein"}]}]},{"id_device":"2160","commercial_name":"Elecsys\u00ae Anti-SARS-CoV-2 S","manufacturer":{"id_manufacturer":"221","name":"ROCHE Diagnostics","country":"Germany","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Lab-based"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The Elecsys Anti SARS CoV 2 S assay uses a recombinant antigen representing the receptor-binding domain (RBD) of the Spike protein in a double-antigen sandwich assay format.  Other pathogens tested for cross-reactivity are: Borrelia burgdorferi; E. coli; Neisseria gonorrhoeae; HEV; HTLV; Listeria; Measles; Parvovirus B19; Plasmodium falciparum; Rubella;; Toxoplasma gondii; Enterovirus; Haemophilus influenza B; Candida albicans; Chlamydia trachomatis; Legionella; ","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1861","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Quantitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"18","performances":[{"parameter":"LOD","value":"0.4","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.8","unit":"%","info":" (95% CI: 98.1 99.3)"},{"parameter":"Clinical Specificity","value":"99.98","unit":"%","info":" (95% CI: 99.91 100)"},{"parameter":"Type of antigen","info":"receptor-binding domain (RBD) of the Spike protein"}]}]},{"id_device":"2156","commercial_name":"Elecsys\u00ae SARS-CoV-2 Antigen","manufacturer":{"id_manufacturer":"221","name":"ROCHE Diagnostics","country":"Germany","website":"https:\/\/diagnostics.roche.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Automated","Lab-based"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":[],"notes":"Elecsys SARS CoV 2 Antigen is an immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) in nasopharyngeal, oropharyngeal and nasal swab samples from patients with signs and symptoms suggestive of COVID 19, or known or suspected exposure to SARS CoV 2. The test is intended as an aid in the diagnosis of SARS CoV 2 infection. The Elecsys SARS CoV 2 Antigen assay uses monoclonal antibodies directed against the SARS CoV 2 nucleocapsid protein in a double-antibody sandwich assay format for the detection of SARS CoV 2 in upper respiratory tract specimens. Specimen collection and preparation: Nasopharyngeal, oropharyngeal and nasal specimens, collected using flocked or polyester-tipped swabs, placed in 3 mL of COPAN Universal Transport Medium (UTM-RT\u2122), BD\u2122 Universal Viral Transport (UVT), Viral Transport Media (VTM, prepared according to CDC SOP#: DSR 052 05), or sterile saline (0.9% NaCl). 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Negative results don\u2019t preclude SARS-CoV-2 infection and they can not be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. 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Mariana Smoluchowskiego 17 ( University Clinical Center, 80-214 Gdansk Mariana Smoluchowskiego 17 street) Person in charge of statistics and unit: Pawel Chrzan PhD Contact number :+48 585844380","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2778","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"13","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"14.5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","unit":"%","info":"97.17(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"85.45","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"ORF1a protein"}]}]},{"id_device":"2511","commercial_name":"Chemtrue\u00ae COVID-19 \uff08SARs-Cov-2\uff09Antigen Rapid Test Kit (Saliva)","manufacturer":{"id_manufacturer":"1076","name":"Shanghai Chemtron Biotech Co. 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Mariana Smoluchowskiego 17 ( University Clinical Center, 80-214 Gdansk Mariana Smoluchowskiego 17 street) Person in charge of Statistics and Unit: Pawel Chrzan PhD. 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The company owns 5 invention patents. The company has invested a lot of resources in the production of materials for in vitro diagnostic reagents, reagent production and technical services for the whole product system. It has a strong R&D and production capacity, and its products sell around all over the word. With the continuous expansion of the market, the output and output value have been increasing year by year, and the company has been rated as a high-tech enterprise by Shenzhen for many years.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2793","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.18","unit":"%"},{"parameter":"False negatives","value":"7","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.91","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%"},{"parameter":"Clinical Specificity","value":"98.82","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2834","commercial_name":"SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay)","manufacturer":{"id_manufacturer":"3201","name":"Shenzhen Aivd Biotechnology Co.LTD.","country":"China","website":""},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Oropharyngeal swab","Saliva"],"pathogen":["Influenza A"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"Shenzhen Aivd Biotechnology Co., LTD., founded in 2014, is a high-tech enterprise specializing in the development, production and service of in vitro diagnostic reagents, which is composed of a team of \"one thousand\" professors from the Organization Department of the Central Committee of the COMMUNIST Party of China and experts with rich R&D experience. The company owns 5 invention patents.  The company has invested a lot of resources in the production of materials for in vitro diagnostic reagents, reagent production and technical services for the whole product system. It has a strong R&D and production capacity, and its products sell around all over the word. With the continuous expansion of the market, the output and output value have been increasing year by year, and the company has been rated as a high-tech enterprise by Shenzhen for many years.","last_updated":"2022-10-26 17:17:51 CET","testList":[{"id_test":"5242","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Other","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Other","subcategory":"Antigen Detection Kit","time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.3","unit":"AU"},{"parameter":"False negatives","value":"7.7","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.52","unit":"%"},{"parameter":"Clinical Specificity","value":"98.87","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1950","commercial_name":"SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay)","manufacturer":{"id_manufacturer":"891","name":"Shenzhen Biocup Biotech Co. Ltd.","country":"China","website":"www.bio-cup.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Shenzhen Biocup Biotech Co., Ltd., established in 2000, is a biomedical high-tech enterprise dedicated to the research, development, production and sales of in vitro diagnostic reagents and medical laboratory instruments. Our company has successively won the honorary titles of \"Shenzhen high tech enterprise\" and \"national high tech enterprise\", ISO9000, ISO13485 quality management system certification and CE certification.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1626","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"45","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"7","unit":"%","info":"The probability of false positive is 7%."},{"parameter":"False negatives","value":"1.18","unit":"%","info":"The probability of false negative is 1.18%."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%"},{"parameter":"Clinical Specificity","value":"98.82","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"365","commercial_name":"Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence)","manufacturer":{"id_manufacturer":"393","name":"Shenzhen Bioeasy Biotechnology Co. Ltd.","country":"China","website":"en.bioeasy.com.tr\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Deep (cough) sputum","Nasal swab","Saliva"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"681","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Fluorescence","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[]}]},{"id_device":"689","commercial_name":"Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test","manufacturer":{"id_manufacturer":"393","name":"Shenzhen Bioeasy Biotechnology Co. 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Ltd.","country":"China","website":"www.cas-envision.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"SARS-CoV-2 Antigen Rapid Detection Kit is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasopharyngeal swab or oropharyngeal swab specimen.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1842","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"34","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.9","unit":"%"},{"parameter":"False negatives","value":"0.5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1995","commercial_name":"COVID-19 Antigen Rapid Test Kit","manufacturer":{"id_manufacturer":"915","name":"Shenzhen Dakewe Bio-engineering Co. Ltd.","country":"China","website":"www.dakewe.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasopharyngeal swab","Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"[Reagents and Materials Provided] COVID-19 Antigen Rapid Test (20 each) Foil pouched test device containing one test strip which is encased in plastic device cassette and one piece of desiccants. Extraction Buffer Vial (20 each) The extraction buffer vial contains 300\u03bcl extraction buffer solution. Collection Swab (20 each) Swabs for nasopharyngeal specimen collection (model CAR1) or swabs for anterior nares specimen collection (model CAR2). Collection Vial (20 each) Vial for the mix of swab specimen and extraction buffer. Preparation Plate (1 each) A 20-holes preparation plate, for fixing the collection vial. Package Insert (1 each) Instructions for use.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1671","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"22.5","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.17","unit":"%","info":"(2\/92)"},{"parameter":"False negatives","value":"0","unit":"%","info":"(0\/78)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"97.5","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1998","commercial_name":"COVID-19 IgM\/IgG Rapid Test Kit","manufacturer":{"id_manufacturer":"915","name":"Shenzhen Dakewe Bio-engineering Co. Ltd.","country":"China","website":"www.dakewe.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"[Reagents and Materials Provided] COVID-19 IgM\/IgG Rapid Test (20 each) Foil pouched test device containing one test strip which is encased in plastic device cassette, one pipette for blood transfer, and one piece of desiccants. Buffer Vial (1 each) The buffer vial contains 10ml phosphate buffered saline (PBS) for sample dilution. Package Insert (1 each) Instructions for use.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1675","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.92","unit":"%","info":"(7\/364)"},{"parameter":"False negatives","value":"6.12","unit":"%","info":"(15\/245)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"93.9","unit":"%"},{"parameter":"Clinical Specificity","value":"98.1","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2415","commercial_name":"Sars-CoV-2 antigen test kit (colloidal gold)","manufacturer":{"id_manufacturer":"609","name":"Shenzhen Dymind Biotechnology Co. Ltd.","country":"China","website":"www.dymind.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"The SARS-CoV-2 Antigen Test Kit is a gold immuno-chromatographic assay (GICA) that is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab (NS) specimens directly from individuals who are suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2117","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"150","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.59","unit":"%"},{"parameter":"False negatives","value":"2.65","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.58","unit":"%","info":" (91.48% -99.06%)"},{"parameter":"Clinical Specificity","value":"98.37","unit":"%","info":" (94.25% - 99.80%)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2418","commercial_name":"SARS-CoV-2 antigen test kit (Saliva sample)","manufacturer":{"id_manufacturer":"609","name":"Shenzhen Dymind Biotechnology Co. 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Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2120","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"150","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.45","unit":"%"},{"parameter":"False negatives","value":"4.65","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.58","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.35","unit":"%"},{"parameter":"Clinical Specificity","value":"97.55","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1161","commercial_name":"SARS-CoV-2 IgM\/IgG Duo Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"609","name":"Shenzhen Dymind Biotechnology Co. 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Thank you very much for the update! Best regards, Anna Zhu","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1799","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"400","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"0 of 210 (100% specificity)"},{"parameter":"False negatives","value":"3.23","unit":"%","info":"5 of 155 (96.77% sensitivity)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.63","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.77","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleoprotein"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2989","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit (Immunofluorescence Assay)","manufacturer":{"id_manufacturer":"1322","name":"Shenzhen Lvshiyuan Biotechnology Co. 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Use only once. 4. Do not touch the reaction area of test strip. 5. Do not use test kit beyond the expiration date. 6. Do not use the kit if the pouch is punctured or sealed not well. 7. Testing should be applied by professionally trained staff working in certified laboratories or clinics. 8. The test result should be interpreted by the physician along with clinical findings and other laboratory test results. 9. 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CoV-Check COVID-19 IgG\/IgM Test Device (Kit Size: 25 Tests \/ Box)2. Sample Buffer (1 Bottle \u2013 3.0 ml)3. 2 ?L Capillary Pipette (25 pipettes \/ Bag)4. Instructions for Use \u2013 1LIMITATIONS1. CoV-Check COVID-19 IgG\/IgM Test Device is limited to the qualitative detection of anti-2019-nCoV antibody levels in serum, plasma, or whole blood specimen. The exact concentration of anti-2019-nCoV antibody cannot be determined by this assay.2. Although the test is very accurate in detecting anti-2019-nCoV antibody, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained.3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.4. 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This test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2721","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"160","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"AU"},{"parameter":"False negatives","value":"38","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.58","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.69","unit":"%"},{"parameter":"Clinical Specificity","value":"99.52","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2488","commercial_name":"Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR Method)","manufacturer":{"id_manufacturer":"1129","name":"Suzhou TianLong Biotechnology Co. 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RT-qPCR kit is validated with Bio-Rad CFX96 Touch\u2122,Applied Biosystem QuantStudio\u202f1 Real-Time PCR System, Roche LightCycler \u00ae 480 and Mic qPCR Cycler. The kit should be stored at -15\u2103 to -25\u2103. It is not recommended to freeze \/ thaw more than 5 times.\". 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The SeroCap Anti-SARS-CoV-2 Neutralizing ELISA is intended to us efor identifiying individuals with adaptive immune response to SARS-CoV-2, due to recent\/prior infection. The SeroCap Neutralizing ELISA kits are designed to capture specifically neutralizing antibodies against SARS-CoV-2. SeroCap SARS-CoV-2 Neutralizing ELISA kit displayed 94% sensitivity and 100% specificity against clinical samples with known neutralizing antbody titers. 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It induce the advantage of the kit with no worry about false positive result. and cDNA synthesis and PCR are done in one tube and multi-targets can detect in one tube in just 3 steps that 1) Premix and primer&probe mixture Mixed up 2) dispense the sample and Positive, Negative control 3) Run the protocol in instrument. The kit also authorized by ISO13485 that quality control management and CE-IVD marked, also approved US FDA EUA. and ceritificate for free sale to export in KOREA. 344 RT-PCR-confirmed cases containing 55 positive and 289 negative specimens are tested. The data above are >14 days from symptom onset to blood collectionMade in Taiwan https:\/\/drive.google.com\/file\/d\/1vJgzeTNjDYsYbbxzvo8N2rNj1vcRhJq6\/view","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"928","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"140","notes":" information provided by the manufacturer + website: SPECIMENS: nasopharyngeal swab samples. Possibly Oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, bronchoalveolar lavage (BAL), and nasopharyngeal, wash\/aspirates or nasal aspirates; CROSSREACTIVITY checked against: Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Adenovirus subtype B, Adenovirus subtype C, Human Metapneumovirus (hMPV), Human parainfluenza 1, Human parainfluenza 2, Human parainfluenza 3, Human parainfluenza 4, Influenza A, Influenza B, Human Respiratory syncytial virus A, Human Respiratory syncytial virus B, Rhinovirus A, Rhinovirus B, Bordetella pertussis, Mycoplasma pneumoniae; INTERNAL CONTROL: primer set and probe to detect a specific region of Human acidic ribosomal protein (HuPO) gene. ","performances":[{"parameter":"LOD","value":"2.5","unit":"copies\/\u03bcl","info":"RdRP gene"},{"parameter":"LOD","value":"3.7","unit":"copies\/\u03bcl","info":"N gene"},{"parameter":"Positive control","info":"artificially synthesized RNA of SARS-CoV-2 RdRP and N genes + short regions from the human acidic ribosomalprotein (HuPO) gene"},{"parameter":"Negative control","info":"Nuclease Free water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"2054","commercial_name":"TODA Autotest Nasal Covid-19","manufacturer":{"id_manufacturer":"681","name":"TODA PHARMA","country":"France","website":"https:\/\/www.todapharma.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""}],"target":["nucleocapsid protein"],"notes":"Please kindly note that the above mentioned performance rates are based on nasal swab.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1734","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.38","unit":"%","info":"On 59 negative samples confirmed by RT-PCR, 57 were also negative with our test : 2 false positives"},{"parameter":"False negatives","value":"0","unit":"%","info":"On 34 positive samples confirmed by RT-PCR, 34 were also negative with our test : 0 false negative"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1959","commercial_name":"Toda Coronadiag +","manufacturer":{"id_manufacturer":"681","name":"TODA PHARMA","country":"France","website":"https:\/\/www.todapharma.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Peripheral blood","Plasma","Serum","Venous whole blood","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[],"target":[],"notes":"Please kindly note that the above mentioned performance rates are valid for IgG and IgM. Please kindly note that the performance rates are based on specimen which have been assessed between Day 14 and Day 19 after onset of symptoms.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1635","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"% IgG"},{"parameter":"Accuracy","value":"100","unit":"% 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protein"}]}]},{"id_device":"1913","commercial_name":"TODA Covdiag Saliva","manufacturer":{"id_manufacturer":"681","name":"TODA PHARMA","country":"France","website":"https:\/\/www.todapharma.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva","Sputum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""}],"target":["nucleocapsid protein","spike protein"],"notes":"Please kindly note that the above mentioned performance rates were assessed on saliva specimens.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1590","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"125","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.42","unit":"%","info":"On 236 negative samples confirmed by RT-PCR, 235 were also negative with our test : 1 false positive"},{"parameter":"False negatives","value":"7.1","unit":"%","info":"On 169 positive samples confirmed by RT-PCR,157 were also positive with our test: 12 false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.9","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1936","commercial_name":"Coronavirus (SARS-CoV 2) Ab IgG \/ IgM - Nucleocapsid (N protein)","manufacturer":{"id_manufacturer":"885","name":"Tody Laboratories Int.","country":"Romania","website":"www.todylaboratories.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Peripheral blood","Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"Nucleocapsid (N) protein as target. IgG Limit of Detection (LoD): 1:40 (0.025) IgM Limit of Detection (LoD): 1:8 (0.125)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1612","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0.025","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.7","unit":"%","info":"From studies performed by manufacturer, the false positive rate is 3.7% (specificity = 96.3%)"},{"parameter":"False negatives","value":"3.1","unit":"%","info":"From studies performed by manufacturer, the false negative rate is 3.1% (sensitivity = 96.9%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.9","unit":"%"},{"parameter":"Clinical Specificity","value":"96.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid (N protein)"}]}]},{"id_device":"1934","commercial_name":"Coronavirus (SARS-CoV 2) Antigen - Oral Fluid","manufacturer":{"id_manufacturer":"885","name":"Tody Laboratories Int.","country":"Romania","website":"www.todylaboratories.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Deep (cough) sputum","Saliva","Sputum"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"Minimum detection limit = 100 pg\/ml","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1610","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"From studies performed by manufacturer, the false positive rate is 0.7% (specificity = 99.3%)"},{"parameter":"False negatives","info":"From studies performed by manufacturer, the false negative rate is 9.9% (sensitivity = 90.1%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1935","commercial_name":"Coronavirus (SARS-CoV 2) Antigen - Swab Specimen","manufacturer":{"id_manufacturer":"885","name":"Tody Laboratories Int.","country":"Romania","website":"www.todylaboratories.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"Detection limit: 100 TCID50\/ml. Performance characteristics using the nasal swab specimen: Sensitivity: 92.9% Specificity: >99.9% Accuracy: 96.2% False positives (nasal swab specimen): From studies performed by manufacturer, the false positive rate is <0.1% (specificity = >99.9%) False negatives (nasal swab specimen): From studies performed by manufacturer, the false negative rate is 7.1% (sensitivity = 92.9%)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1611","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"From studies performed by manufacturer, the false positive rate is 1.0% (specificity = 99.0%)"},{"parameter":"False negatives","value":"3.6","unit":"%","info":"From studies performed by manufacturer, the false negative rate is 3.6% (sensitivity = 96.4%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid (N) protein"}]}]},{"id_device":"1933","commercial_name":"Coronavirus (SARS-CoV-2) Neutralizing Antibodies","manufacturer":{"id_manufacturer":"885","name":"Tody Laboratories Int.","country":"Romania","website":"www.todylaboratories.com\/"},"ce_marking":"Yes","commercial_status":"Unknown","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Other"],"target_type":["Antibody","IgG","IgM"],"specimen":["Peripheral blood","Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"Anti-Spike Protein, Colloidal Gold","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1609","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0.025","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.7","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1497","commercial_name":"Trueline COVID-19 Ag Rapid Test","manufacturer":{"id_manufacturer":"689","name":"TP Medicare GmbH","country":"Germany","website":"www.tp-medicare.de\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1247","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"False positives","value":"0","unit":"%","info":"0 of 21"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"1 of 37"},{"parameter":"Accuracy","value":"98.1","unit":"%"},{"parameter":"Clinical Sensitivity","value":"93.8","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"nucleocapside"}]}]},{"id_device":"1750","commercial_name":"SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR )","manufacturer":{"id_manufacturer":"782","name":"TransGen Biotech Co. Ltd.","country":"China","website":"www.transgenbiotech.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1428","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"60","performances":[{"parameter":"LOD","value":"0.5","unit":"copies\/\u03bcl"},{"parameter":"Positive control","info":"In vitro transcribed RNA for ORF1ab, N genes and the internal control-RP gene"},{"parameter":"Negative control","info":"RNase-free Water"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Throughput","value":"96","unit":"samples\/run"}]}]},{"id_device":"1026","commercial_name":"3gamma COVID-19 IgA \/ IgM \/ IgG","manufacturer":{"id_manufacturer":"608","name":"Tregena","country":"Italy","website":"www.3gamma.it\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM","IgA"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":" 344 RT-PCR-confirmed cases containing 55 positive and 289 negative specimens are tested. The data above are >14 days from symptom onset to blood collectionMade in Taiwan http:\/\/www.3gamma.it\/1\/upload\/brochure_3_gamma.pdf","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"938","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"20","performances":[{"parameter":"Clinical Sensitivity","value":"99","unit":"%"},{"parameter":"Clinical Specificity","value":"95.2","unit":"%"}]}]},{"id_device":"812","commercial_name":"Bartels FlexTrans Medium","manufacturer":{"id_manufacturer":"473","name":"Trinity Biotech plc","country":"Ireland","website":"www.trinitybiotech.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other"],"target_type":["Other"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"654","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":"Phosphor technology","subcategory":null,"time_minutes":null,"notes":"   ","performances":[]}]},{"id_device":"3152","commercial_name":"Uni-Gold SARS_CoV-2 Antigen Test","manufacturer":{"id_manufacturer":"1393","name":"Trinity Biotech plc","country":"Ireland","website":"www.trinitybiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Please send any questions regarding clarifications to micheal.roche@trinitybiotech.com","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2860","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","notes":"antigen_epi Monoclonals are mouse IgM, one recognises the conformational epitope, the other the linear epitope","performances":[{"parameter":"LOD","value":"1.3","unit":"ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.05","unit":"%","info":"Prospective study: False positives 2\/189"},{"parameter":"False negatives","value":"1.07","unit":"%","info":"CT<32 = 1\/93"},{"parameter":"False negatives","value":"0","unit":"%","info":"CT<28 = 0\/77"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.9","unit":"%","info":"CT<32  92\/93 "},{"parameter":"Clinical Sensitivity","value":"100","unit":"%","info":"CT<28 = 77\/77"},{"parameter":"Clinical Specificity","value":"98.9","unit":"%","info":"187\/189 - Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1465","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit","manufacturer":{"id_manufacturer":"677","name":"Triplex International Biosciences (China) Co. Ltd.","country":"China","website":"www.tibchina.com\/index_en.aspx"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1207","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"1.49","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.52","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.51"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"2074","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit","manufacturer":{"id_manufacturer":"959","name":"Triplex International Biosciences (China) Co. Ltd.","country":"China","website":"www.tibchina.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC","Other"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Other","Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Lineages detected: A.23.1; AT.1;B.1.1.7(Alpha); B.1.351 (Beta); B.1.427(Epsilon); B.1.429(Epsilon); B.1.525 (Eta); B.1.526(Iota); B.1.617.1(Kappa); B.1.617.2 (Delta); B.1.617.3;B.1.621 (Mu); C.36;P.1(Gamma); P.2(Zeta); P.3 (Theta); C.37 (Lambda); B.1.616; B.1.1.529 (Omicron); B.1.526.1; B.1.526.2;","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1756","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"40","unit":"TCID50\/ml","info":"40-100TICD 50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.49","unit":"%"},{"parameter":"False negatives","value":"0.09","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.54","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.51","unit":"%"},{"parameter":"Clinical Specificity","value":"99.91","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1461","commercial_name":"SARS-CoV-2 IgM\/IgG Rapid Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"677","name":"Triplex International Biosciences (China) Co. 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","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"23","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"1117","commercial_name":"COVID KAVACH Anti-SARS CoV-2 Human IgG ELISA","manufacturer":{"id_manufacturer":"19","name":"Trivitron Healthcare Pvt. 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POC"],"target_type":["Antigen"],"specimen":["Saliva","Sputum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Saliva tests are self-administered; this means that after you are shown how to perform the test, you\u2019ll do it by yourself. You will spit several times into a funnel attached to a tube, and then screw on a cap to complete the sample collection. Saliva tests are more comfortable than nasal swabs and just as accurate.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2226","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"2870","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.33","unit":"%","info":"4\/300"},{"parameter":"False negatives","value":"0.33","unit":"%","info":"1\/300"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.17","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.67","unit":"%"},{"parameter":"Clinical Specificity","value":"99.67","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2826","commercial_name":"Unibioscience\u00ae COVID-19 Ag Home Test","manufacturer":{"id_manufacturer":"1150","name":"Unibioscience AS","country":"Turkey","website":"www.unibioscience.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""}],"target":[],"notes":"The Unibioscience COVID-19 Ag Home Test is a lateral flow immunoassay intended to detect nucleocapsid antigen from the SARS-CoV-2 virus that causes COVID-19 in anterior nasal swabs from individuals age 2 years and older; for prescription use only tests, such as symptomatic individuals who are suspected of COVID-19 by a healthcare provider, or individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2531","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"2000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"AU"},{"parameter":"False negatives","value":"4","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.375","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.67","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.67","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2521","commercial_name":"Vaxxitest 2019-nCoV Neutralizing Antibody Test","manufacturer":{"id_manufacturer":"1150","name":"Unibioscience AS","country":"Turkey","website":"www.unibioscience.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"MAIN COMPONENTS of Vaxxitest\u2122 Reagent: composed of test strips, plastic parts (box), buffer, and dropper; Test Strip main components: 1. Recombinant protein ACE-2 (fixed in the nitrocellulose membrane detection area), Goat anti-rabbit lgG polyclonal antibody (fixed on nitrocellulose membrane quality control area). 2. Colloidal gold-labelled novel coronavirus protein RBD (located on polyester cellulose membrane); colloidal gold-labelled rabbit lgG. Buffer: mainly composed of disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride. Colorimetric Card Additional preparation for testing: specimen collection containers and timer.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2225","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"20","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6","unit":"%"},{"parameter":"False negatives","value":"2","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.24","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.98","unit":"%"},{"parameter":"Clinical Specificity","value":"94.74","unit":"%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"2131","commercial_name":"OnSight\u2122 - COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"988","name":"Unimed International Inc.","country":"United States","website":"www.unimed.net"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"LOD: 1.26 x 102 TCID50\/mL","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1821","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"126","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.6","unit":"%"},{"parameter":"False negatives","value":"3.9","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2133","commercial_name":"OnSight\u2122 - COVID-19 IgG\/IgM Combo Test","manufacturer":{"id_manufacturer":"988","name":"Unimed International Inc.","country":"United States","website":"www.unimed.net"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"Digital result reading with a Reader,","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1823","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"N.A."},{"parameter":"False negatives","info":"N.A."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.3","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2135","commercial_name":"OnSight\u2122- COVID-19 NAb Quantitative Test","manufacturer":{"id_manufacturer":"988","name":"Unimed International Inc.","country":"United States","website":"www.unimed.net"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"OnSight\u2122- COVID-19 NAb Quantitative Test is an in vitro Rapid \u201cSandwich\u201d immunochromatography test for the \u201cQuantitative\u201d detection of circulating functional Neutralizing Antibodies (NAb) Titer post COVID-19 Vaccination or after SARS-CoV-2 Infection using a Reader. OnSight\u2122 - COVID-19 NAb Quantitative Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. OnSight\u2122- COVID-19 NAb Quantitative Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https:\/\/www.jimmunol.org\/content\/206\/10\/2393) OnSight\u2122- COVID-19 NAb Quantitative Test has been standardized against \u201cFirst WHO International Standard for anti-SARS-CoV-2 Immunoglobulins\u201d (NIBSC Code: 20\/136) with excellent Correlation Coefficient (R2 = 0.99). Limit of Detection (LOD): 25 \u2013 50 BAU\/ml (Test Lot dependent).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1825","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","unit":"AU","info":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.17","unit":"%"},{"parameter":"Clinical Specificity","value":"98.67","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2249","commercial_name":"COVID-19 ANTIGEN RAPID TEST NASAL","manufacturer":{"id_manufacturer":"1047","name":"Unioninvest Ltd.","country":"Turkey","website":"www.unibioscience.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Validation of the Unibioscience SARS CoV-2 Antigen Rapid Nasal Test was performed in correlation with the respective Ct values of the positive PCR samples, including clinical data on the duration of disease symptoms. Validation tests of PCR samples from symptomatic individuals with symptom onset before 5 days (N=400) resulted in a sensitivity of 99.00% (95% CI: 97.46%-99.73%) with a mean Ct value of 26.17 (Min 17.2 - Max 39.4). From the validation tests of PCR samples with a Ct value < 30 (N=250), a mean Ct value of 22.30 (Min 17.20-Max 29.90) resulted in a sensitivity of 99.60% (95% CI: 97.79%-99.9%). From the validation tests of PCR samples with a Ct value \u2265 30 (N=150), a mean Ct value of 32.60 (Min 30.1-Max 39.4) resulted in a sensitivity of 98.00% (95% CI: 94.27%-99.59%) The PCR test used in the validations was real-time PCR. The EasyprepFast real-time PCR kit was used. SARS-Cov-2 was the target genome. The corresponding target gene was the N1 and the E gene with the following primers: SARS-CoV-2_IBS_N1 \/ SARS-CoV-2_IBS_E2For the internal positive control (IPC), a GAPDH primer set was used. FAM, HEX and Cy5 dyes were applied for staining.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1950","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"7.57","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.25","unit":"%","info":"1\/400"},{"parameter":"False negatives","value":"1","unit":"%","info":"4\/400"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","info":" (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"698","commercial_name":"UBI SARS-CoV-2 ELISA","manufacturer":{"id_manufacturer":"426","name":"United Biomedical","country":"United States","website":"www.unitedbiomedical.com"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Antibody"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"582","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"ELISA","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"413","commercial_name":"Two single-step quantitative RT reverse transcription PCR assays for\u00a0N\u00a0gene and\u00a0ORF1b\u00a0of sarbecovirus subgenus","manufacturer":{"id_manufacturer":"265","name":"University of Hong Kong","country":"Hong Kong S.A.R","website":"www.hku.hk\/"},"ce_marking":"No","commercial_status":"Unknown","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"Shipped to WHO\u00a0+30 labs globally","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"335","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"414","commercial_name":"COVID-19 PCR, on WHO protocol","manufacturer":{"id_manufacturer":"266","name":"University of North Carolina Medical Center McLendon Clinical Laboratories","country":"United States","website":"www.uncmedicalcenter.org\/mclendon-clinical-laboratories\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"336","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"415","commercial_name":"Tongue swab diagnosis of SARS-CoV-2","manufacturer":{"id_manufacturer":"267","name":"University of Washington","country":"United States","website":"www.deohs.washington.edu"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Other"],"target_type":["Other"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-12-02 09:22:17 CET","testList":[{"id_test":"337","assay_category":"Other","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Other","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"416","commercial_name":"COVID-19 test","manufacturer":{"id_manufacturer":"268","name":"UPMC","country":"United States","website":"www.upmc.com\/about"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"339","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"RT-PCR","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2600","commercial_name":"Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal AmplificationReal Time Fluorescence Assay)","manufacturer":{"id_manufacturer":"1187","name":"Ustar Biotechnoligies","country":"China","website":"http:\/\/en.bioustar.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC","Other"],"target_type":["Nucleic acid"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Saliva","Sputum"],"pathogen":[],"lineage":[],"target":[],"notes":"This kit used Cross Priming Amplification (CPA) to detect ORF1ab and N gene sequences specific to the novel coronavirus (2019-nCoV).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2305","assay_category":"Nucleic acid-Other","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Other","measurement":"Qualitative","subclass":"Multiple","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"49","performances":[{"parameter":"LOD","value":"200","unit":"cpm"},{"parameter":"Positive control","info":"Pseudovirion"},{"parameter":"Negative control","info":"Pseudovirion with GAPDH gene"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%"},{"parameter":"Clinical Specificity","value":"95.4","unit":"%"}]}]},{"id_device":"1874","commercial_name":"2019- nCoV and Flu A\/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay)","manufacturer":{"id_manufacturer":"860","name":"Ustar Biotechnologies (Hangzhou) Ltd.","country":"China","website":"en.bioustar.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"The 2019- nCoV and Flu A\/B Antigen Combo Rapid Test is used for in vitro qualitative detection of the nucleoprotein antigen of influenza A, influenza B and Novel Coronavirus (2019- nCoV) in samples from human oropharyngeal swabs, nasopharyngeal swabs and saliva.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1555","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"960","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"NA"},{"parameter":"False negatives","info":"NA"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.94","unit":"%","info":"(96.12%-99.05%\uff09"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.65","unit":"%","info":"(91.25%-98.23%)"},{"parameter":"Clinical Specificity","value":"99.27","unit":"%","info":"(97.40%-99.91%)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1873","commercial_name":"2019- nCoV Antigen Rapid Test","manufacturer":{"id_manufacturer":"860","name":"Ustar Biotechnologies (Hangzhou) Ltd.","country":"China","website":"en.bioustar.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Oropharyngeal swab","Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"The 2019-nCoV Antigen Rapid Test is intended for qualitative in-vitro diagnosis of the nucleoprotein antigen of novel coronavirus (2019-nCoV) in the human saliva, oropharyngeal and nasopharyngeal swab samples.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1763","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"1879","commercial_name":"2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay)","manufacturer":{"id_manufacturer":"860","name":"Ustar Biotechnologies (Hangzhou) 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Moreover, it is currently in use in Germany, Portugal, Czechia, Slovenia, Estonia, Sweden and Luxembourg.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1881","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"(91 out of 100)"},{"parameter":"False negatives","value":"3","unit":"%","info":"(3 out of 100)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"3126","commercial_name":"RapidFor SARS-CoV-2 Rapid Antigen Test (FIA)","manufacturer":{"id_manufacturer":"1016","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-09-29 09:43:02 CET","testList":[{"id_test":"20283","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"-","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"%","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False positives","value":"0.79","unit":"%","info":"3 out of 379 (NP Swab for InfB)"},{"parameter":"False positives","value":"0.53","unit":"%","info":"2 out of 375 (NP Swab for InfA)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"3.03","unit":"%","info":"5 out of 165 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.56","unit":"%","info":"4 out of 156 (NP Swab for InfA)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.53","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Accuracy","value":"98.87","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.44","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"96.97","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.21","unit":"%","info":"NP swab:(Inf B)"}]}]},{"id_device":"4063","commercial_name":"RapidFor\u2122 SARS-CoV-2 & FLU A\/B Rapid Antigen Test","manufacturer":{"id_manufacturer":"678","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-11-17 10:04:42 CET","testList":[{"id_test":"5331","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"()","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False positives","value":"0.53","unit":"%","info":"2 out of 375 (NP Swab for InfA)"},{"parameter":"False positives","value":"0.79","unit":"%","info":"3 out of 379 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"3.03","unit":"%","info":"5 out of 165 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.56","unit":"%","info":"4 out of 156 (NP Swab for InfA)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Accuracy","value":"98.53","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Accuracy","value":"98.87","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"97.44","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Sensitivity","value":"96.97","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Specificity","value":"99.21","unit":"%","info":"NP swab:(Inf B)"}]}]},{"id_device":"5804","commercial_name":"RapidFor\u2122 SARS-CoV-2 + FLU A\/B + RSV Combo Test Kit","manufacturer":{"id_manufacturer":"678","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-12-22 08:49:09 CET","testList":[{"id_test":"20282","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"-","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"%","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False positives","value":"0.87","unit":"%","info":"2 out of 231(NP Swab for RSV)"},{"parameter":"False positives","value":"0.79","unit":"%","info":"3 out of 379 (NP Swab for InfB)"},{"parameter":"False positives","value":"0.53","unit":"%","info":"2 out of 375 (NP Swab for InfA)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"2.24","unit":"%","info":"5 out of 223 (NP Swab for RSV)"},{"parameter":"False negatives","value":"3.03","unit":"%","info":"5 out of 165 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.56","unit":"%","info":"4 out of 156 (NP Swab for InfA)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Accuracy","value":"98.87","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Accuracy","value":"98.53","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Accuracy","value":"98.46","unit":"%","info":"NP swab:(RSV)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"97.44","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Sensitivity","value":"96.97","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Sensitivity","value":"97.76","unit":"%","info":"NP swab:(RSV)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Specificity","value":"99.21","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Specificity","value":"99.13","unit":"%","info":"NP swab:(RSV)"}]}]},{"id_device":"5816","commercial_name":"RapidFor\u2122 SARS-CoV-2 + FLU A\/B + RSV+ADV Combo Test Kit","manufacturer":{"id_manufacturer":"678","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2023-01-09 10:06:31 CET","testList":[{"id_test":"5418","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Chromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"-","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False positives","value":"0.82","unit":"%","info":"2 out of 223 (NP Swab for ADV)"},{"parameter":"False positives","value":"0.53","unit":"%","info":"2 out of 375 (NP Swab for InfA)"},{"parameter":"False positives","value":"0.79","unit":"%","info":"3 out of 379 (NP Swab for InfB)"},{"parameter":"False positives","value":"0.87","unit":"%","info":"2 out of 231(NP Swab for RSV)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"1.78","unit":"%","info":"4 out of 225 (NP Swab for ADV)"},{"parameter":"False negatives","value":"2.24","unit":"%","info":"5 out of 223 (NP Swab for RSV)"},{"parameter":"False negatives","value":"3.03","unit":"%","info":"5 out of 165 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.56","unit":"%","info":"4 out of 156 (NP Swab for InfA)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"97.44","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Sensitivity","value":"96.97","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Sensitivity","value":"97.76","unit":"%","info":"NP swab:(RSV)"},{"parameter":"Clinical Sensitivity","value":"98.22","unit":"%","info":"NP swab:(ADV)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Specificity","value":"99.21","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Specificity","value":"99.13","unit":"%","info":"NP swab:(RSV)"},{"parameter":"Clinical Specificity","value":"99.18","unit":"%","info":"NP swab:(ADV)"}]}]},{"id_device":"5834","commercial_name":"RapidFor\u2122 SARS-CoV-2 +FLUA\/B + RSV + ADV + M. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2023-01-13 13:46:41 CET","testList":[{"id_test":"5441","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Chromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"-","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"%","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False positives","value":"1.19","unit":"%","info":"3 out of 108 (NP Swab for M. 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Pneumoniae )"},{"parameter":"False negatives","value":"1.78","unit":"%","info":"4 out of 225 (NP Swab for ADV)"},{"parameter":"False negatives","value":"3.03","unit":"%","info":"5 out of 165 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.56","unit":"%","info":"4 out of 156 (NP Swab for InfA)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"97.22","unit":"%","info":"NP Swab for M. Pneumoniae "},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"98.81","unit":"%","info":"NP Swab for M. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia in 2022. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-09-29 09:41:53 CET","testList":[{"id_test":"5313","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"()","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (Nasopharyngeal Swab)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (Nasopharyngeal Swab)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"}]}]},{"id_device":"2992","commercial_name":"RapidSens SARS-CoV-2 Rapid Antigen Test","manufacturer":{"id_manufacturer":"1016","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-09-29 09:42:19 CET","testList":[{"id_test":"5314","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"()","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (Nasopharyngeal Swab)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (Nasopharyngeal Swab)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"}]}]},{"id_device":"1658","commercial_name":"SARS-CoV-2 Neutralizing Antibody Test Kit","manufacturer":{"id_manufacturer":"678","name":"Vitrosens Biotechnology Co. 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The T line is immobilized with anti-human IgG for detecting novel coronavirus neutralizing antibody and the C line is immobilized with a quality control antibody. When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains Novel coronavirus neutralizing antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The immune complex will be captured by the anti- human IgG antibody immobilized on the membrane to form a purple-red T line, showing that the novel coronavirus Neutralizing antibody is positive. The test card also contains a quality control line C.The fuchsia quality control line C should appear regardless of whether a test line appears. If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card. The IgG test is based on the principle of colloidal gold immunochromatography to quaitatively detect the new coronavirus SARS-CoV-2 IgG antibody in serum, plasma or whole blood samples. When the SARS-CoV-2 IgG level in the specimen is at or above the target cutoff (the detection limit of the test), the antibody bound to the antigen-dye conjugate are captured by anti-human IgG immobilized in the Test Region (T) of the device, and this produces a colored test band that indicates a positive result. When the SARS-CoV-2 IgG level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (T) of the device. This indicates a negative result. 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CET","testList":[{"id_test":"364","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"ELISA","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"445","commercial_name":"ReSARS Pan-Corona Rapid Test","manufacturer":{"id_manufacturer":"281","name":"Zalgen Labs LLC","country":"United States","website":"www.zalgen.com\/"},"ce_marking":"No","commercial_status":"In development","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 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(98+210)\/ (98+0+2+210) *100%=99.35% (95%CI* 97.58% to 99.43%) Pe= (100*98+210*212)\/ (310*310) =0.557 Kappa:( P0 - Pe)\/(1-pe) =0.992","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2547","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"0","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.35","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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The mutant virus strains that have been found worldwide are derived from the SARS-CoV-2 20B\/GR evolutionary strain (lineage B.1.1.7), including many mutation, the mutation location is the spike (S) protein of the new coronavirus, which is the location where the SARS-CoV-2 virus uses to bind to the cell's ACE2 receptor. The ZEKMED LUNA Ag Antigen Rapid Test Kit (N) produced by ZEKMED Ltd, is used for in vitro qualitative detection of SARS-CoV-2 virus nucleocapsid (N) protein in human nasopharyngeal , oropharyngeal , anterior -nasal or saliva samples. It can be seen that the mutation sites of mutated virus strains including Omicron strain have no effect on the detection rate of the kits produced by our company. The kit is suitable for assay of the SARS-CoV-2 variant virus called 'Omicron '.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2559","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Legionella pneumophila, Streptococcus pneumonia, Streptococcus pyrogens, Human etapneumovirus (hMPV) 3 Type B1","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False 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detection of (Covid-19) SARS COV-2 antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. 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