{"extracted_on":"2026-04-17 02:28:46 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 gene plasmid and RdRp gene plasmid"},{"parameter":"Negative control","info":"DEPC distilled water"},{"parameter":"Throughput","info":"Single tubes"}]}]},{"id_device":"2921","commercial_name":"1copy\u2122 COVID-19 MDx Kit Professional","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":["Near POC \/ POC"],"target_type":null,"specimen":["Nasopharyngeal 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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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protein","nucleocapsid protein","ORF1ab polyprotein"],"notes":"1copy\u2122 COVID-19 qPCR 4plex 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, nasal aspirate and saliva specimens collected from individuals suspected of COVID-19 by their healthcare providers. 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. Negative results must be combined with clinical observations, patient history, and epidemiological information. 1copy\u2122 COVID-19 qPCR Triplex 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":"2623","assay_category":"Nucleic acid-PCR","rapid_diagnostic":null,"self_test":"Yes","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":"E gene plasmid and N gene plasmid"},{"parameter":"Negative control","info":"DEPC DW"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2919","commercial_name":"1copy\u2122 COVID-19\/FluA\/FluB\/RSV 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":["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":["nucleocapsid protein","ORF1ab polyprotein"],"notes":"1copy\u2122 COVID-19\/FluA\/FluB\/RSV qPCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2, Influenza A, Influenza B and RSV 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. 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":"2252","commercial_name":"ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit","manufacturer":{"id_manufacturer":"1050","name":"3D Biomedicine Science & Technology Co. Limited","country":"China","website":"https:\/\/www.3dmedcare.com\/support\/contact.htm"},"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":"1953","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":"200","unit":"cpm"},{"parameter":"Positive control","info":"yes"},{"parameter":"Negative control","info":"yes"}]}]},{"id_device":"2","commercial_name":"2019-nCoV RT-qPCR","manufacturer":{"id_manufacturer":"2","name":"3D Medicines","country":"China","website":"www.3dmedcare.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":"Performance of 3D 2019-nCoV RT-qPCR Detection Kit has only been established in the specimens collected with oropharyngeal swabs and nasopharyngeal swabs.  ","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. Internal control"},{"parameter":"Negative control","info":"Not found"},{"parameter":"Analytical Specificity","info":"tested negative with 27 species of Viruses\/Bacteria\/Parasites"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"PPA 96-100% compared to NGS assays and CDC method"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"NPA 100%-100% compared to NGS and CDC method"},{"parameter":"Throughput","info":"Single tubes"}]}]},{"id_device":"4","commercial_name":"3DMed 2019-nCoV RT-qPCR Detection Kit","manufacturer":{"id_manufacturer":"2","name":"3D Medicines","country":"China","website":"www.3dmedcare.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":["Biochip"],"format":["Manual"],"target_type":["Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"5","assay_category":"Nucleic 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tubes"}]}]},{"id_device":"504","commercial_name":"A*STAR Fortitude Kit 2.0","manufacturer":{"id_manufacturer":"10","name":"A*ccelerate","country":"Singapore","website":"www.accelerate.tech\/"},"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":"401","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":"Manual NAT   ","performances":[]}]},{"id_device":"13","commercial_name":"A*STAR Fortitude Kit 2.0 (Singapore HSA) \u2013 PCR kit","manufacturer":{"id_manufacturer":"10","name":"A*ccelerate","country":"Singapore","website":"www.accelerate.tech\/"},"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":"13","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":"963","commercial_name":"PRESTO 2019-nCoV Direct qPCR 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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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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":"736","commercial_name":"Accula SARS-CoV-2 test","manufacturer":{"id_manufacturer":"437","name":"Mesa Biotech","country":"United States","website":"www.mesabiotech.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":"596","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":"897","commercial_name":"COVID-19 qPCR kit","manufacturer":{"id_manufacturer":"500","name":"Meslo","country":"Cyprus","website":"www.meslo.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":"710","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.meslo.com\/category\/704\/Coronavirus-qPCR-test-Kits--and--Rapid-Kits-COVID-19.html","performances":[{"parameter":"LOD","value":"100","unit":"copies\/reaction"}]}]},{"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 indivisual suspected of coronavirus disease 2019. Consultation with a medical specialist is required for final diagnosis. 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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":"2502","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":"120","performances":[{"parameter":"LOD","value":"273.8","unit":"cpm","info":"ABI7500"},{"parameter":"LOD","value":"126.1","unit":"cpm","info":"CFX96"},{"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":"2796","commercial_name":"Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-QM","manufacturer":{"id_manufacturer":"1254","name":"MiCo Biomed Co. 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http:\/\/nextpharmainc.com\/","performances":[{"parameter":"Clinical Sensitivity","value":"96.7","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"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. 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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. 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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":"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":"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. 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Endogenous Internal Control is co-extracted and coamplified in order to monitor all the procedure. Available separated software for results automatic interpretation.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1997","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":null,"performances":[{"parameter":"Positive control","info":"Present, used during the amplifcation phase"},{"parameter":"Negative control","info":"NTC, which can be extracted with samples or directly amplified"}]}]},{"id_device":"302","commercial_name":"New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel","manufacturer":{"id_manufacturer":"193","name":"NY State Department of Health","country":"United States","website":"www.wadsworth.org\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["IgG","IgM","IgA","Nucleic acid"],"specimen":null,"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"250","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":"Type of antigen","info":"SARS-CoV-2 Nucleocapsid recombinant antigen"}]}]},{"id_device":"1927","commercial_name":"SARS-CoV-2 One-Step RT-PCR Kit","manufacturer":{"id_manufacturer":"880","name":"NZYTech","country":"Portugal","website":"www.nzytech.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":["Other"],"pathogen":[],"lineage":[],"target":[],"notes":"Assay validated on widely used qPCR instruments including ABI\u00ae 7500, ABI\u00ae StepOnePlus\u2122, ABI\u00ae QuantStudio\u2122 6, Bio-Rad\u00ae CFX96, Qiagen\u00ae Rotor-Gene Q, Roche\u00ae LC 480 II. NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N genes (IVD) provides the complete set of reagents and probes to qualitatively detect the SARS-CoV-2 genome, through common realtime PCR platforms. The virus RNA dependent RNA polymerase (RdRp) and the Nucleocapsid phosphoprotein (N) genes have previously been identified as highly specific markers for SARS-CoV-2. This NZYTech kit targets specific regions in the RdRp and N genes of SARS-CoV-2 genome to provide the highest sensitivity of detection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1603","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":"target RdRp and N Genes","performances":[{"parameter":"LOD","value":"0.15","unit":"cpu"},{"parameter":"Positive control","info":"SARS-CoV-2(RdRp & N genes)\/RP Positive Control"},{"parameter":"Negative control","info":"SARS-CoV-2 Neg (RdRp & N) - RNase\/DNase free water"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"967","commercial_name":"Corona Virus Disease 2019 (CoViD-19) Nucleic Acid Detection Kit","manufacturer":{"id_manufacturer":"520","name":"OACP 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