{"extracted_on":"2026-06-10 07:47:51 CET","deviceList":[{"id_device":"1454","commercial_name":"COVID-19\/Flu A\/B Antigen Combo Rapid Test","manufacturer":{"id_manufacturer":"340","name":"GenSure Biotech Inc.","country":"China","website":"www.gensbio.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1204","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Accuracy: 97.5 (Influenza A); 96.9 (Influenza B). Clinical sensitivity: 91.7 (Influenza A); 86.2 (Influenza B)","performances":[{"parameter":"LOD","value":"50","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"The samples collected were contaminated, do not follow the instructions manual, etc. "},{"parameter":"False negatives","info":"Samples collected contained low levels of the virus, do not follow the instructions manual, etc. "},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.9","unit":"%","info":"(COVID-19)"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.9","unit":"%","info":"(COVID-19)"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"1253","commercial_name":"GenSure COVID-19 Antigen Rapid Kit","manufacturer":{"id_manufacturer":"340","name":"GenSure Biotech Inc.","country":"China","website":"www.gensbio.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"GenSure COVID-19 Antigen Rapid Test Kit (REF: P2004)","last_updated":"2022-11-28 10:30:56 CET","testList":[{"id_test":"5343","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Not found","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"96.86","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%"},{"parameter":"False negatives","value":"3.14","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.91","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2853","commercial_name":"GenSure COVID-19 Antigen Rapid Test Kit","manufacturer":{"id_manufacturer":"340","name":"GenSure Biotech Inc.","country":"China","website":"www.gensbio.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","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":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1322","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2558","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"There is a very small possibility of false positives."},{"parameter":"False negatives","info":"There is a very small possibility of false negatives."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.68","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.73","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"565","commercial_name":"GenSure COVID-19 IgG\/IgM Rapid Test (REF: P2002)","manufacturer":{"id_manufacturer":"340","name":"GenSure Biotech Inc.","country":"China","website":"www.gensbio.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"450","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":[]}]},{"id_device":"566","commercial_name":"GenSure COVID-19 IgM Rapid Test (REF: P2001)","manufacturer":{"id_manufacturer":"340","name":"GenSure Biotech Inc.","country":"China","website":"www.gensbio.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","IgM"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"452","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":"Clinical Sensitivity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"95","unit":"%"}]}]},{"id_device":"1826","commercial_name":"GenSure COVID-19 Neutralizing Antibody Test (Fluorescence)","manufacturer":{"id_manufacturer":"340","name":"GenSure Biotech Inc.","country":"China","website":"www.gensbio.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1503","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"Evaluated"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"}]}]},{"id_device":"2112","commercial_name":"GenSure COVID-19 Neutralizing Antibody Test (Latex)","manufacturer":{"id_manufacturer":"979","name":"GenSure Biotech Inc.","country":"China","website":"http:\/\/www.gensbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":["Antibody"],"specimen":null,"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"}],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1802","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunoassay","measurement":null,"subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"There is a very small possibility of false positives."},{"parameter":"False negatives","info":"There is a very small possibility of false negatives."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"94.6","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]}]}