{"extracted_on":"2024-04-25 19:44:39 CET","deviceList":[{"id_device":"1363","commercial_name":"COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"413","name":"Hangzhou Clongene Biotech Co. Ltd.","country":"China","website":"http:\/\/en.clongene.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":[],"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":"1495","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3116","lineage_name":"B.1.616","lineage_country":""},{"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":"1313","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"15","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2016","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1430","lineage_name":"C.36","lineage_country":""},{"id_lineage":"60","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1214","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":"668","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1494","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"A prospective clinical study conducted in Greece from Nov. 2021 to Feb. 2022, the performance of COVID-19 Antigen Rapid Test was evaluated by detection of 626 nasopharyngeal swab specimens, setting a RT-PCR detection of nasopharyngeal specimens as comparator. The test showed a sensitivity of 95.5% (n=150\/157, 95%CI: 91.1%-97.8%) and a specificity of 100% (n=469\/469, 95%CI: 99.2%-100%). A genotyping analysis on unselected 88 PCR-positive specimens identified 31 cases of Omicron infection, those comparator PCR Ct values ranged from 10.5 to 31.1 (7\/31 at Ct >25) and all of which were positive by COVID-19 Antigen Rapid Test. Thus, the test performance is not affected by Omicron variant.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1122","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"antigen_epi AA95-175","performances":[{"parameter":"LOD","unit":"TCID50\/ml","info":"570 TCID50\/mL"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%","info":"0%"},{"parameter":"False negatives","unit":"%","info":"4%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"Nasal swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Sensitivity","value":"95.5","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Nasal swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]}]}