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For in vitro diagnostic use only.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2490","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","info":"PRNT50 1:27"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.1","unit":"%","info":"1 false positive out of 90 PRNT negative samples"},{"parameter":"False negatives","value":"6.5","unit":"%","info":"5 false negative out of 77 PRNT positive samples"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"93.5","unit":"%","info":"95% C.I. 85.68~97.19%"},{"parameter":"Clinical Specificity","value":"98.9","unit":"%","info":"95% C.I. 93.97~99.80%"}]}]},{"id_device":"837","commercial_name":"Ichroma COVID-19 Ab, IgM\/IgG","manufacturer":{"id_manufacturer":"22","name":"Boditech Med Inc.","country":"South Korea","website":"https:\/\/www.boditech.co.kr\/en"},"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 CET","testList":[{"id_test":"687","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":"Fluorescence","subcategory":null,"time_minutes":"10","performances":[]}]},{"id_device":"2398","commercial_name":"ichroma\u2122 COVID-19 nAb","manufacturer":{"id_manufacturer":"1104","name":"Boditech Med Inc.","country":"South Korea","website":"www.boditech.co.kr\/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"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"ichroma\u2122 COVID-19 nAb is a fluorescence Immunoassay (FIA) for the qualitative determination of neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the ACE-2 cell surface receptor in human whole blood\/serum\/plasma. 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For in vitro diagnostic use only.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2489","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"37","unit":"AU\/mL","info":"BAU\/mL (NP IgG)"},{"parameter":"LOD","value":"26","unit":"AU\/mL","info":"BAU\/mL (SP IgG)"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.3","unit":"%","info":"SP IgG"},{"parameter":"False positives","value":"8.3","unit":"%","info":"NP IgG"},{"parameter":"False negatives","value":"4","unit":"%","info":"SP IgG"},{"parameter":"False negatives","value":"0","unit":"%","info":"NP IgG"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.8","unit":"%","info":"SP IgG"},{"parameter":"Accuracy","value":"98.3","unit":"%","info":"NP IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.7","unit":"%","info":"SP IgG"},{"parameter":"Clinical Sensitivity","value":"91.7","unit":"%","info":"NP IgG"},{"parameter":"Clinical Specificity","value":"96","unit":"%","info":"SP IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"NP IgG"}]}]},{"id_device":"2033","commercial_name":"Rapid Response COVID-19 IgG\/IgM Rapid Test Device","manufacturer":{"id_manufacturer":"62","name":"BTNX Inc.","country":"Canada","website":"www.btnx.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 Rapid Response COVID-19 IgG\/IgM Rapid Test Device has been CE marked since April of 2020. 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":"% 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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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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"],"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 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":"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":"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":"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":"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). 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IgG-Spike erfasst sowohl die Immunreaktion auf SARS-CoV-2-Infektionen als auch auf SARS-CoV-2-Impfungen. Bei der Immunreaktion auf Impfung ist die Sensitivit\u00e4t 95,7% Spezifit\u00e4t 100% Genauigkeit 97,9%. 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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"],"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"],"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. 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":"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":"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 S-RBD IgG Antibody Test Cassette is a fluorescence 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.It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2028","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunoassay","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":"0.048","unit":"AU"},{"parameter":"False negatives","value":"0.011","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%","info":"\uff08Antibody\uff09"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.2","unit":"%","info":"\uff08Antibody\uff09"},{"parameter":"Clinical Specificity","value":"98.9","unit":"%","info":"\uff08Antibody\uff09"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"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. 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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"],"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":"2059","commercial_name":"SARS-CoV-2 IgM\/IgG Antibody Test Kit (colloidal gold method)","manufacturer":{"id_manufacturer":"949","name":"Hangzhou Bioer Technology Co. 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Indirect method.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1597","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":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.92","unit":"%","info":"2 false positive results are observed in 104 negative samples"},{"parameter":"False negatives","value":"0","unit":"%","info":"No false negative result is observed in 152 positive samples"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","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":"4114","commercial_name":"SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Combo)","manufacturer":{"id_manufacturer":"128","name":"Hangzhou Biotest Biotech Co. 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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":"% 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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. 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DEVICE DESCRIPTION: REVEALCOVID-19TM Total Antibody Test is a manually performed, visually interpreted Rapid Vertical Flow\u00ae (RVF) immunoassay that detects total antibodies to SARS-CoV-2, the causative agent of COVID-19 disease, in human serum, plasma and venipuncture whole blood. REVEALCOVID-19TM Total Antibody Test consists of a Test Cartridge, an InstantGold Cap, and two (2) vials of pre-aliquoted universal buffer solutions. Test Cartridge consists of two plastic casings (top and bottom) that snap together to securely hold the reactive nitrocellulose membrane overlaid on top of the absorbent pad. The Test Zone of the membrane is coated with a combination of synthetic proteins that correspond to the conserved regions of the SARS-CoV-2 nucleocapsid protein (N), thus, allowing the capture of SARS-CoV-2 antibodies. As a procedural\/reagent control, Protein A is immobilized in a designated area (Control Zone) on the nitrocellulose membrane to allow a non-specific capture of Ig antibodies. InstantGold cap, which contains proprietary Protein A\/L colloidal gold conjugates, enables the visualization of the aforementioned antigen \u2013 antibody immunocomplexes formed on the reactive membrane. Universal buffer solutions are proprietary formulations of ionic and non-ionic detergents in Tris-buffered saline that serve four main functions: a) lysis of blood cells in whole blood specimens; b) optimization of the interactions between capture antigens on the test membrane and antibodies present in the specimen; c) reduction of non-specific binding to the membrane; d) reconstitution of the colorimetric detection agent in the InstantGold Cap.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2085","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"3","performances":[{"parameter":"LOD","value":"20","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.22","unit":"%","info":"Plasma: 1\/37 (PPA = 97.1%)"},{"parameter":"False positives","value":"0","unit":"%","info":"Serum: 0\/31 (PPA = 100%)"},{"parameter":"False positives","value":"3.22","unit":"%","info":"Whole Blood: 1\/37 (PPA = 97.1%)"},{"parameter":"False negatives","value":"1.61","unit":"%","info":"Plasma: 2\/124 (NPA = 98.1)"},{"parameter":"False negatives","value":"0.91","unit":"%","info":"Serum: 1\/110 (NPA = 99.0%), "},{"parameter":"False negatives","value":"0","unit":"%","info":"Whole Blood: 0\/37 (NPA = 100%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.5","unit":"%"},{"parameter":"Clinical Specificity","value":"98.7","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1068","commercial_name":"MEDsan COVID-19 IgM\/IgG Rapid Test Hybrid","manufacturer":{"id_manufacturer":"617","name":"MEDsan GmbH","country":null,"website":"https:\/\/www.medsan.eu\/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"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"  https:\/\/www.medsan.eu\/en\/detection\/","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"995","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":"10","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"],"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":"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":"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"],"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"],"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":"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":"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":"1629","commercial_name":"recomWell SARS-CoV-2 IgG","manufacturer":{"id_manufacturer":"725","name":"Mikrogen Diagnostik","country":"Germany","website":"www.mikrogen.de"},"ce_marking":"Yes","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":"1309","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":"390","performances":[{"parameter":"Analysis of cross reactivity","info":"Seasonal coronaviruses (HCoV), Influenza A virus, Influenza B virus, Respiratory syncytial virus (RSV), Adenoviruses, Mycoplasma pneumoniae, Chlamydia pneumoniae, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), Autoantibodies positive, Pregnant women, R"},{"parameter":"Clinical Sensitivity","value":"98","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"73","unit":"% IgA"},{"parameter":"Clinical Specificity","value":"98.7","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.3","unit":"% IgA"}]}]},{"id_device":"285","commercial_name":"SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay","manufacturer":{"id_manufacturer":"477","name":"Mokobio Biotechnology R&D Center","country":"United States","website":"www.mokobious.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"660","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":"60","performances":[{"parameter":"Clinical Sensitivity","value":"89.52","unit":"%"},{"parameter":"Clinical Specificity","value":"99.36","unit":"%"}]}]},{"id_device":"1329","commercial_name":"COVID-19 IgA ELISA","manufacturer":{"id_manufacturer":"410","name":"Monocent Inc.","country":"United States","website":"www.monocent.com"},"ce_marking":"Yes","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":"1098","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"85","notes":"Manual or automated   ","performances":[{"parameter":"Accuracy","value":"99.59","unit":"% IgA"},{"parameter":"Clinical Sensitivity","value":"98.7","unit":"% IgA"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"1327","commercial_name":"COVID-19 IgG ELISA","manufacturer":{"id_manufacturer":"410","name":"Monocent Inc.","country":"United States","website":"www.monocent.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1096","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"70","notes":"Manual or automated   ","performances":[{"parameter":"Accuracy","value":"97","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"95","unit":"% IgG"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"1321","commercial_name":"COVID-19 IgG\/IgM Rapid Test","manufacturer":{"id_manufacturer":"410","name":"Monocent Inc.","country":"United States","website":"www.monocent.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1087","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"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":"AU"},{"parameter":"False negatives","value":"0","unit":"AU"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"}]}]},{"id_device":"1328","commercial_name":"COVID-19 IgM ELISA","manufacturer":{"id_manufacturer":"410","name":"Monocent Inc.","country":"United States","website":"www.monocent.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1097","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"ELISA","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"85","performances":[{"parameter":"Accuracy","value":"99.44","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"96","unit":"% IgM"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"937","commercial_name":"ASSURE SARS-CoV-2 IgG\/IgM Rapid Test","manufacturer":{"id_manufacturer":"367","name":"MP Biomedicals","country":"Germany","website":"https:\/\/www.mpbio.com\/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"],"specimen":["Plasma","Serum","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"737","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":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Accuracy","value":"99.43","unit":"%"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical Specificity","value":"99.41","unit":"%"}]}]},{"id_device":"1125","commercial_name":"Human anti-SARS-CoV-2 IgG ELISA Kit","manufacturer":{"id_manufacturer":"367","name":"MP Biomedicals","country":"Germany","website":"https:\/\/www.mpbio.com\/eu\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antibody"],"specimen":["Other biological fluids","Plasma","Tissue 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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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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. 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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. To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2548","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":"Qualitative","subclass":"Microtiter","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"nAbs\uff1aL1\uff5eL3,L1 and L2 are positive,L3 is positive or negative. 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The LOD value of IgG of the COVID-19 Neutralizing Antibody multiple Detection Kit is 1:512.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2011","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"512","info":"IgG"},{"parameter":"LOD","value":"512","unit":"AU","info":"N Ab"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"8.4","unit":"% IgG","info":"First vaccinated in 14 days"},{"parameter":"False positives","value":"3.4","unit":"%","info":"(N Ab) - Completely vaccinated more than 28 days "},{"parameter":"False positives","value":"1.6","unit":"% IgG","info":"Completely vaccinated more than 28 days "},{"parameter":"False negatives","value":"0","unit":"% IgG","info":"First vaccinated in 14 days"},{"parameter":"False negatives","value":"0","unit":"%","info":"(N Ab) - Completely vaccinated more than 28 days"},{"parameter":"False negatives","value":"0","unit":"% IgG","info":"Completely vaccinated more than 28 days"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"% IgG","info":"Completely vaccinated more than 28 days"},{"parameter":"Accuracy","unit":"%","info":"(N Ab) - Completely vaccinated more than 28 days"},{"parameter":"Accuracy","value":"100","unit":"% IgG","info":"First vaccinated in 14 days"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.6","info":"First vaccinated in 14 days: "},{"parameter":"Clinical Sensitivity","value":"98.6","unit":"% IgG","info":"Completely vaccinated more than 28 days"},{"parameter":"Clinical Sensitivity","value":"96.6","unit":"%","info":"(N Ab) - Completely vaccinated more than 28 days"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(NP swab)"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG","info":"(OP swab)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Stool)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Sputum\/oropharyngeal saliva)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Front Nostril)"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1966","commercial_name":"COVID-19 NAb Rapid Test","manufacturer":{"id_manufacturer":"900","name":"Zhejiang Kuaye Biotechnology Co. 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Neutralizing antibodies which may be present in the specimen compete against S-RBD conjugate for binding sites on the ACE2. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action along the cassette. Neutralizing antibodies to SARS-CoV-2, if not present in the specimen, will not saturate the binding sites of S-RBD coated on the particles. The S-RBD coated particles will then be captured by the ACE2, which is pre-coated on test line region, and a visible colored line will show up in the test line region. The color intensity of the test line decreases as the concentration of neutralizing antibodies increases. The colored line will not form in the test line region if there are sufficient neutralizing antibodies in the specimen, because they will saturate all the binding sites of the S-RBD coated on the particles. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2200","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":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"0 on 68"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 on 59"},{"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":"Spike protein"}]}]},{"id_device":"453","commercial_name":"BIOCELL COVID-19 IgG ELISA test","manufacturer":{"id_manufacturer":"292","name":"Zhengzhou Humanwell Biocell Biotechnology Co. 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