{"extracted_on":"2026-06-13 10:56:28 CET","deviceList":[{"id_device":"1970","commercial_name":"COVID-19 IgG\/IgM Rapid Test Cassette","manufacturer":{"id_manufacturer":"887","name":"Hangzhou Sejoy Electronics & Instruments Co. 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German Paul-Ehrlich-Institut (PEI) evaluated this test under test-ID AT 1269\/21","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2854","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%"},{"parameter":"False negatives","value":"6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.5","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2063","commercial_name":"SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette","manufacturer":{"id_manufacturer":"887","name":"Hangzhou Sejoy Electronics & Instruments Co. Ltd.","country":"China","website":"sejoy.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"We have also evaluated the interference substances.","last_updated":"2022-10-05 14:06:10 CET","testList":[{"id_test":"3934","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"40050","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"3","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1945","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette","manufacturer":{"id_manufacturer":"887","name":"Hangzhou Sejoy Electronics & Instruments Co. Ltd.","country":"China","website":"sejoy.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"The cross substances and interference substance are also evaluated.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1621","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"400","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"3","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2671","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette","manufacturer":{"id_manufacturer":"887","name":"Hangzhou Sejoy Electronics & Instruments Co. Ltd.","country":"China","website":"sejoy.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":["nucleocapsid protein"],"notes":"We have also evaluated interference substance as following:Whole Blood,Ibuprofen,Tetracycline,Mucin,Erythromycin,Tobramycin,Menthol,Afrin, Compound Benzoin Gel,Cromolyn glycate , Chloramphenicol ,Mupirocin,Oseltamivir,Naphazoline Hydrochlo-ride Nasal Drops,Fluticasone propionate spray,Deoxyepinephrine hydro-chloride","last_updated":"2023-03-02 11:30:05 CET","testList":[{"id_test":"21058","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Other","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"87","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%"},{"parameter":"False negatives","value":"13","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.79","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"87","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1952","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva)","manufacturer":{"id_manufacturer":"887","name":"Hangzhou Sejoy Electronics & Instruments Co. Ltd.","country":"China","website":"sejoy.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":["nucleocapsid protein"],"notes":"We have also evulated the interference substance.","last_updated":"2023-02-23 18:20:31 CET","testList":[{"id_test":"20251","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"400","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"97.4","unit":"%"},{"parameter":"Analytical Specificity","value":"99.1","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"tests","info":"2(Nasal swab),3(Oropharyngeal swabs),2(Nasopharyngeal swabs),3(Saliva)"},{"parameter":"False negatives","value":"3","unit":"tests","info":"3(Nasal swab),5(Oropharyngeal swabs),3(Nasopharyngeal swabs),5(Saliva)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.5","unit":"%","info":"98.48%(Nasal swab),98.67%(Oropharyngeal swabs),98.48%(Nasopharyngeal swabs),98.46%(Saliva)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%","info":"97.4%(Nasal swab),95.76%(Oropharyngeal swabs),97.4%(Nasopharyngeal swabs),95.65%(Saliva)"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%","info":"99.1%(Nasal swab),99.38%(Oropharyngeal swabs),99.1%(Nasopharyngeal swabs),99.26%(Saliva)"}]}]},{"id_device":"2740","commercial_name":"SARS-CoV-2 Antigen Saliva Lolly Test","manufacturer":{"id_manufacturer":"952","name":"Hangzhou Sejoy Electronics & Instruments Co. Ltd.","country":"China","website":"http:\/\/www.sejoy.com.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"About interference,we also have evaluated.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2445","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"400000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"AU"},{"parameter":"False negatives","value":"7","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.55","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.91","unit":"%"},{"parameter":"Clinical Specificity","value":"99.15","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2062","commercial_name":"SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette","manufacturer":{"id_manufacturer":"952","name":"Hangzhou Sejoy Electronics & Instruments Co. Ltd.","country":"China","website":"http:\/\/www.sejoy.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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"We have also evaluated the cross reactivity and interference substances.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1742","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"neutralizing antibody","performances":[{"parameter":"LOD","value":"5050","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"AU"},{"parameter":"False negatives","value":"2","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]}]}