{"extracted_on":"2024-05-02 18:36:23 CET","deviceList":[{"id_device":"1736","commercial_name":"COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"24","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.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":["Anterior nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"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":"1. Passed the UK Department of Health and Social Care (DHSC) Phase 3B validation. - Only 4 to 5 manufacturers all over the world have passed Phase 3B. 2. Germany PEI Eveluation. 3. Delta and Omicron variants clinical validation in EU countries.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1415","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","notes":"Other pathogens tested for cross-reactivity: Streptococcus pneumoniae, Streptococcus pyogenes, Candida albicans, Pneumocystis jirovecii, Legionella pneumophila, Pseudomonas Aeruginosa, Staphylococcus Epidermidis, Streptococcus Salivarius","performances":[{"parameter":"LOD","value":"80","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.2","unit":"%"},{"parameter":"False negatives","value":"3.6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.03","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]}]}