{"extracted_on":"2024-04-20 03:20:16 CET","deviceList":[{"id_device":"1333","commercial_name":"COVID-19 Rapid Antigen Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"44","name":"Joinstar Biomedical Technology Co. Ltd.","country":"China","website":"www.joinstar.cn"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"679","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1022","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1471","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1213","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1122","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1127","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1310","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1311","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1312","lineage_name":"B.1.617.3","lineage_country":""},{"id_lineage":"15","lineage_name":"A.23.1","lineage_country":""}],"target":["nucleocapsid protein"],"notes":"Evaluation performed by Paul-Ehrlich Institut on 4th December 2020","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1105","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunoassay","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","info":"pg\/mL"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.86","unit":"%","info":"(From 215 samples tested there were 4 false positives)"},{"parameter":"False negatives","value":"1.39","unit":"%","info":"(From 215 samples tested there were 3 false negatives)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.6","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.1","unit":"%"},{"parameter":"Clinical Specificity","value":"98.1","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]}]}