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Influenza A 97 (Antigen), Influenza B 98(Antigen)."},{"parameter":"Accuracy","value":"97","unit":"%","info":"Influenza A (Antigen)"},{"parameter":"Accuracy","value":"98","unit":"%","info":"Influenza B (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"85","unit":"%","info":"SARS-CoV-2 Nasopharingeal (Antigen)"},{"parameter":"Clinical Sensitivity","value":"89","unit":"%","info":"SARS-CoV-2 Nasal (Antigen)"},{"parameter":"Clinical Sensitivity","value":"86","unit":"%","info":"Influenza A (Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2459","commercial_name":"Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit","manufacturer":{"id_manufacturer":"1122","name":"Acura Kliniken Baden-Baden GmbH","country":"Germany","website":"https:\/\/acura-kliniken.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","Antigen"],"specimen":["Deep (cough) sputum","Oropharyngeal swab","Other biological fluids","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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Pleas contact B.Grunberg: B.Grunberg@acura-kliniken.com","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2162","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.33","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2896","commercial_name":"RAPiDgen SARS-CoV-2 Ag Test","manufacturer":{"id_manufacturer":"304","name":"ADALTIS srl","country":"Italy","website":"www.adaltis.net\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"For all study participants the antigen rapid test correctly identified 91.87% of infected participants, and 99.04% of noninfected participants . For patients with a relatively high viral load (Ct\u226430), the relative sensitivity was 95.74% (N=188). The RAPiDgenSARS-CoV-2 Ag Test detects SARS-CoV-2 nucleoprotein (N). This protein has 419 amino acids. The RAPiDgenSARS-CoV-2 Ag Test detects the C-terminal end of this protein (specifically AA247-364)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2601","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"4 on 418 negative samples tested during the clinical trial"},{"parameter":"False negatives","value":"8.12","unit":"%","info":"16 on 197 positive samples tested during the clinical trial"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.75","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.87","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"0.04","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2448","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)","manufacturer":{"id_manufacturer":"1115","name":"ADS Biotec Inc.","country":"United States","website":"www.adsbiotec.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Serum"],"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":[],"notes":"http:\/\/4ffkhs61xjo3g7q3l6b7s61t.wpengine.netdna-cdn.com\/wp-content\/uploads\/YIG-AR-0010-SARS-CoV-2-Antigen-Rapid-Test-CE-IVD-declaration.pdf Note: additional materials required that are not supplied include UV flashlight with a wavelength of 365 nm, vortex mixer and timer. LOD; Serum - 3.5 pg\/mL Swabs - 7.0 pg\/mL","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2151","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"7","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":" (serum) "},{"parameter":"False positives","value":"0.4","unit":"%","info":" (swab)"},{"parameter":"False negatives","value":"4","unit":"%","info":" (serum) "},{"parameter":"False negatives","value":"3","unit":"%","info":" (swab)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.72","unit":"%","info":"(95.54%-99.23%)."},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.12","unit":"%","info":" antigen (swab); "},{"parameter":"Clinical Sensitivity","value":"96.04","unit":"%","info":"(serum)"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":" antigen (swab) "},{"parameter":"Clinical Specificity","value":"98.9","unit":"%","info":"(serum)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2736","commercial_name":"ADTech COVID-19 Ag RAPID KIT","manufacturer":{"id_manufacturer":"1241","name":"ADTech Co. 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InfectCheck\u00ae COVID-19 NAb Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. InfectCheck\u00ae COVID-19 NAb Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https:\/\/www.jimmunol.org\/content\/206\/10\/2393) InfectCheck\u00ae COVID-19 NAb Test has been standardized against \u201cFirst WHO International Standard for anti-SARS-CoV-2 Immunoglobulins\u201d (NIBSC Code: 20\/136) with excellent Correlation Coefficient (R2 = 0.99). Limit of Detection (LOD): 25 \u2013 50 BAU\/ml (Test Lot dependent).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1827","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"NAb test","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.17","unit":"%"},{"parameter":"Clinical Specificity","value":"98.67","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2130","commercial_name":"TestNOW\u00ae - COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"987","name":"Affimedix Inc.","country":"United States","website":"www.affimedix.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"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"Digital Result option available with a Reader.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1820","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"126","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.6","unit":"%"},{"parameter":"False negatives","value":"3.9","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.1","unit":"%","info":"Anterior Nasal Swab"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Nasopharyngeal Swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Anterior Nasal Swab"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"Nasopharyngeal Swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2132","commercial_name":"TestNOW\u00ae - COVID-19 IgG\/IgM Test","manufacturer":{"id_manufacturer":"987","name":"Affimedix Inc.","country":"United States","website":"www.affimedix.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"Digital Result reading with a Reader","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1822","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU","info":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"N.A."},{"parameter":"False negatives","info":"N.A."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.3","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2134","commercial_name":"TestNOW\u00ae - COVID-19 NAb Quantitative Test","manufacturer":{"id_manufacturer":"987","name":"Affimedix Inc.","country":"United States","website":"www.affimedix.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"TestNOW\u00ae - COVID-19 NAb Quantitative Test is an in vitro Rapid \u201cSandwich\u201d immunochromatography test for the \u201cQuantitative\u201d detection of circulating functional Neutralizing Antibodies (NAb) Titer post COVID-19 Vaccination or after SARS-CoV-2 Infection using a Reader. TestNOW\u00ae - COVID-19 NAb Quantitative Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. TestNOW\u00ae - COVID-19 NAb Quantitative Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https:\/\/www.jimmunol.org\/content\/206\/10\/2393) TestNOW\u00ae - COVID-19 NAb Quantitative Test has been standardized against \u201cFirst WHO International Standard for anti-SARS-CoV-2 Immunoglobulins\u201d (NIBSC Code: 20\/136) with excellent Correlation Coefficient (R2 = 0.99). 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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"}]}]},{"id_device":"1815","commercial_name":"COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) - Nasal Swab","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","Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https:\/\/www.medrxiv.org\/content\/10.1101\/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https:\/\/www.medrxiv.org\/content\/10.1101\/2021.01.13.21249563v1.full-text And we have attached the MHRA registration certificate. Also the registration in Germany, registration in Italy, registration in Portugal and so on.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1493","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"320","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"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":"Nucleoprotein"}]}]},{"id_device":"2750","commercial_name":"COVID-19 (SARS-CoV-2) Antigen Test Kit (self-testing)","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":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"We obtained CE1434 self-test certificate and the registration in Germany, registration in Italy, registration in Portugal and so on.Also we have attached the MHRA registration certificate. Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https:\/\/www.medrxiv.org\/content\/10.1101\/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https:\/\/www.medrxiv.org\/content\/10.1101\/2021.01.13.21249563v1.full-text","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2455","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"80","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"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"}]}]},{"id_device":"2651","commercial_name":"COVID-19 (SARS-CoV-2) Antigen Test Midstream \u2014 Saliva","manufacturer":{"id_manufacturer":"1020","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.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":["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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"This product is used for in vitro qualitative detection of the antigen of SARS-CoV-2 in human saliva specimen. It finished registration in Germany and also in German BfArM List.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2356","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"80","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.05","unit":"%"},{"parameter":"False negatives","value":"2.5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.5","unit":"%"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2189","commercial_name":"COVID-19 (SARS-CoV-2) Neutralizing Antibody (Double Antigen Sandwich) Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"1020","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"This product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody in human serum, plasma, whole blood and\/or fingertip blood. This product uses double antigen sandwich method for detection. The gold label pad is marked with S-RBD-mFc C-terminal, and the detection line is coated with S-RBD-mFc N-terminal. When the sample contains neutralizing antibody, it will bind to S-RBD-mFc C-terminal, then the complex will be captured by pre-coated S-RBD-mFc N-terminal and the T line will show color. When the sample does not contain neutralizing antibodies, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1890","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"20","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False negatives","value":"7","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2198","commercial_name":"COVID-19 (SARS-CoV-2) Neutralizing Antibody IgG Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"1020","name":"Anhui Deep Blue Medical Technology Co. Ltd.","country":"China","website":"www.dbluemedical.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["IgG"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"This product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody IgG in human serum, plasma, whole blood and\/or fingertip blood. This product uses capture method for detection. The gold label pad is marked with S-RBD protein, and the detection line is coated with mouse-anti-human IgG. When the sample contains neutralizing antibody IgG, it will bind to the S-RBD protein, then the complex will be captured by pre-coated mouse anti-human IgG and the T line will show color. When the sample does not contain neutralizing antibodies IgG, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody IgG.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1899","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.2","unit":"%"},{"parameter":"False negatives","value":"7.8","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.2","unit":"%"},{"parameter":"Clinical Specificity","value":"95.7","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2089","commercial_name":"New Coronavirus (COVID-19) Antigen Rapid Test","manufacturer":{"id_manufacturer":"967","name":"Anhui Formaster Biosci Co. 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This kit uses a nasal swab sample to reduce discomfort which can be applied to any person ranging from age 18 to 70. Adolescents or children can be tested under adult supervision or tested by an adult. 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Ltd.","country":"China","website":"www.hotgen.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":["Anterior nasal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":[],"notes":"The product has obtained the CE0123 certificate issued by the notified body, and has entered the German self-test whitelist, the French self-test whitelist and the Austrian self-test whitelist.","last_updated":"2022-10-17 11:54:37 CET","testList":[{"id_test":"5303","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"79.2","unit":"TCID50\/ml","info":"Limit of detection is 5*10^1.2TCID50\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.11","unit":"%","info":"The 269 negative samples, 3 of them is false positives."},{"parameter":"False negatives","value":"3.05","unit":"%","info":"The 131 positive samples, 4 of them should is false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.25","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.95","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"98.88","unit":"%","info":"Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2808","commercial_name":"Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"1069","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":"www.hotgen.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":["Peripheral blood","Serum","Venous whole blood","Whole blood with anti-coagulants"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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":[],"notes":"There are acolorimetric cards in the product, and the user can judge the semi-quantitative result based on the colorimetric card.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2513","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.25","unit":"AU","info":"The cut off Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies in serum samples detected by this kit was determined to be 0.250(O"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.69","unit":"%","info":"869 samples have 6 false positives"},{"parameter":"False negatives","value":"1.47","unit":"%","info":"339 samples have 5 false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.09","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.53","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.31","unit":"% IgG"}]}]},{"id_device":"1870","commercial_name":"Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"328","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":"www.hotgen.com.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","Throat 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":"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"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"This kit is used for in vitro qualitative determination of novel coronavirus antigen in human nasal swabs or throat swabs. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.","last_updated":"2022-09-20 14:48:19 CET","testList":[{"id_test":"3834","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"396.22","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.38","unit":"%"},{"parameter":"False negatives","value":"0.24","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.87","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.62","unit":"%"},{"parameter":"Clinical Specificity","value":"99.76","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2841","commercial_name":"Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"1069","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":"www.hotgen.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":["Anterior nasal swab","Nasal swab","Throat swab"],"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":"1132","lineage_name":"B.1.427","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":"1439","lineage_name":"C.36","lineage_country":""}],"target":[],"notes":"The product can detect different types of sample.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2546","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"396.22","unit":"TCID50\/ml","info":"2.5\u00d710^2.2 TCID50\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.11","unit":"%","info":"269 positive samples, 3 were false negative."},{"parameter":"False negatives","value":"3.05","unit":"%","info":"131 positive samples, 4 were false negative."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.25","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.85","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"98.88","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2809","commercial_name":"Novel Coronavirus(SARS-CoV-2) Neutralizing AntibodiesTest (Up-converting Phosphor Immunochromatographic Technology)","manufacturer":{"id_manufacturer":"1256","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":null},"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","Venous whole blood","Whole blood","Whole blood with anti-coagulants"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":[],"notes":"Products need to pass UPT instrument testing to obtain results.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2514","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Neutralization Antibody (NAb)","detection_principle":"Phosphor technology","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.25","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.57","unit":"%","info":"869 negative samples have 5 false positives."},{"parameter":"False negatives","value":"1.17","unit":"%","info":"339 positive samples have 4 false negatives."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.25","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.82","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.42","unit":"% IgG"}]}]},{"id_device":"2811","commercial_name":"SARS-CoV-2 (S-RBD & NP) Antibody Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"1069","name":"Beijing Hotgen Biotech Co. Ltd.","country":"China","website":"www.hotgen.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","Venous whole blood","Whole blood with anti-coagulants"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":[],"notes":"Two test results can be obtained through this product test: S-RBD antibody and NP antibody.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2516","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"15","unit":"AU\/mL","info":"15BAU\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"408 negative samples have no false positives."},{"parameter":"False negatives","value":"0.43","unit":"%","info":"230 positive samples have 1 false negative."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.84","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.57","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"}]}]},{"id_device":"2810","commercial_name":"SARS-CoV-2 and Flu A\/B Antigen Combo Rapid Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"1256","name":"Beijing Hotgen Biotech Co. 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When the sample is added to the test device, the sample will be absorbed into the device by capillary action, mixing with SARS- CoV-2 recombinant antigen-color latex conjugate and flowing through the pre-coated membrane. When the COVID-19 IgG antibody or IgM antibody level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen- color latex conjugate are captured by anti-human IgG antibody immobilized on the Test Region (G)of the device or anti-human IgMantibody immobilized on the Test Region(M), and This produces one or two color teststrips indicating a positive result. When theCOVID-19 IgG\/IgM antibodies level in thespecimen is zero or below the target cutoff,there is not a visible colored band in the TestRegion (G M) of the device. This indicates anegative result. To serve as a procedure control, a colored linewill appear at the Control Region (C), if the testhas been performed properly.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2411","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"0","unit":"% IgG"},{"parameter":"False positives","value":"1.1","unit":"% IgM"},{"parameter":"False negatives","value":"2.7","unit":"% IgG"},{"parameter":"False negatives","value":"0","unit":"% IgM"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"% IgG"},{"parameter":"Accuracy","value":"99","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"98.9","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"97.3","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgM"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2895","commercial_name":"2019-nCoV IgM\/IgG Antibody Test Kit\uff08Colloidal Gold\uff09","manufacturer":{"id_manufacturer":"1272","name":"Biobase Biodustry\u00ef\u00bc\u02c6Shandong\u00ef\u00bc\u2030 Co. 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Ltd.","country":"China","website":"https:\/\/www.biobase.cc\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":["Coronaviruses (HCoV)"],"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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"The Biobase COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-COV-2. The Test is intended for self-testing of anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2819","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"7.27","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.62","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.73","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3071","commercial_name":"BIOBASE COVID-19 Antigen Rapid Test\uff08Self-Test\uff09","manufacturer":{"id_manufacturer":"1358","name":"Biobase Diagnostic Technology (Shandong) Co. 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This test kit is intended for self-testing at home for individuals with symptoms of SARS-CoV-2 infection. This test kit shall not be used as a sole basis to diagnose or exclude SARS-CoV-2 infection.","last_updated":"2022-11-07 14:20:27 CET","testList":[{"id_test":"5288","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"115","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%"},{"parameter":"False negatives","value":"7.27","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.62","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.73","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2673","commercial_name":"Tell Me Fast COVID19 Antigen Test","manufacturer":{"id_manufacturer":"322","name":"Biocan Diagnostics Inc.","country":"Canada","website":"www.rapidtest.ca"},"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":["Anterior nasal swab","Mid-turbinates swab","Nasopharyngeal swab"],"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":"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":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""}],"target":[],"notes":"Please let us know what additional information is required by you.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2378","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":"140.6","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"AU"},{"parameter":"False negatives","value":"5","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3099","commercial_name":"RAPID SARS-COV-2 ANTIGEN TEST CARD","manufacturer":{"id_manufacturer":"1376","name":"BioDetect (Xiamen) Biotechnology Co. 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protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3223","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Other","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"120","unit":"TCID50\/ml"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"False positives","value":"4","unit":"samples"},{"parameter":"False negatives","value":"8","unit":"samples"}]}]},{"id_device":"2247","commercial_name":"CoviGnost AG Test Device 1x20","manufacturer":{"id_manufacturer":"1046","name":"BioGnost Ltd.","country":"Croatia","website":"www.biognost.hr"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"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"}],"target":[],"notes":"The Contract OEM manufacturer of the Test Device is Hangzhou Alltest Biotech CO., Ltd whose COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is allready on the Common list of rapid antigen tests, as agreed by Member States (May 10. pg.10) Our CoviGnost AG Test Device is validated at Croatian Institute of Public Health with excellent validation report. We sold CoviGnost AG Test Device in Croatia, Bulgaria, Italy and Greece, without any complaint.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1948","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","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","value":"2.44","unit":"%","info":"3\/123"},{"parameter":"False negatives","value":"1.23","unit":"%","info":"1\/81"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"}]}]},{"id_device":"2481","commercial_name":"CoviGnost AG test devices","manufacturer":{"id_manufacturer":"1046","name":"BioGnost Ltd.","country":"Croatia","website":"www.biognost.hr"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"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":"20","lineage_name":"A.23.1","lineage_country":""}],"target":[],"notes":"COVID-19 Antigen Rapid Test CoviGnost AG is a qualitative chromatographic immunoassay for detection of SARS-CoV-2 antigens in human nasopharyngeal swab specimens.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2184","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.4","unit":"%","info":"Total 82 \/ 2 false positives"},{"parameter":"False negatives","value":"1.56","unit":"%","info":"Total 192 \/ 3 false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2694","commercial_name":"BOH-180 Fluorescent Immunoassay Analyzer","manufacturer":{"id_manufacturer":"1037","name":"BIOHIT HealthCare (Hefei) Co. Ltd.","country":"China","website":"www.biouhan.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC","Semi-automated"],"target_type":["Antibody","Antigen"],"specimen":["Anterior nasal swab"],"pathogen":["Adenovirus","Chlamydia Pneumoniae","Cytomegalovirus (CMV)","Enterovirus A71 (EV-A71)","Epstein-Barr Virus (EBV)","Hepatitis B Virus (HBV)","Hepatitis C Virus (HCV)","Herpes Simplex (HSV)","Human Immunodeficiency Virus (HIV)","Influenza A","Influenza B","Mycoplasma Pneumoniae","Parainfluenza Virus Type","Respiratory Syncytial V (RSV)","Varicella Zoster Virus (VZV)"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"BOH-180 is a small bench top analyzer intended to be used with cassette-based immunofluorescent IVD assays manufactured by Biohit Healthcare (Hefei) Co., Ltd.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2399","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Other","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"1","performances":[{"parameter":"LOD","value":"12.69","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.71","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.12","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2692","commercial_name":"SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Anterior Nasal Swab","manufacturer":{"id_manufacturer":"1037","name":"BIOHIT HealthCare (Hefei) Co. Ltd.","country":"China","website":"www.biouhan.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC","Semi-automated"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":["Adenovirus","Chlamydia Pneumoniae","Cytomegalovirus (CMV)","Enterovirus A71 (EV-A71)","Hepatitis B Virus (HBV)","Hepatitis C Virus (HCV)","Herpes Simplex (HSV)","Human Immunodeficiency Virus (HIV)","Mycoplasma Pneumoniae","Parainfluenza Virus Type","Respiratory Syncytial V (RSV)","Varicella Zoster Virus (VZV)"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"This rapid kit is used for the semi-quantitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples with the supporting Fluorescent Immunoassay Analyzer. Antigene epitope information: N\u2010terminal domain (NTD; 46\u2013176 aa) C\u2010terminal domain (CTD; 247\u2013364 aa)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2397","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"12.69","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.71","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.12","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2693","commercial_name":"SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Blood","manufacturer":{"id_manufacturer":"1037","name":"BIOHIT HealthCare (Hefei) Co. 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Antigen epitope information: N\u2010terminal domain (NTD; 46 \u2013176 aa) C\u2010terminal domain (CTD; 247\u2013364 aa).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2398","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"16","performances":[{"parameter":"LOD","value":"8.92","info":"pg\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.69","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.63","unit":"%"},{"parameter":"Clinical Specificity","value":"99.72","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2230","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"1037","name":"BIOHIT HealthCare (Hefei) Co. 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This rapid kit is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1931","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"200","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.15","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.12","unit":"%"},{"parameter":"Clinical Specificity","value":"99.49","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1286","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)","manufacturer":{"id_manufacturer":"53","name":"BIOHIT HealthCare (Hefei) Co. 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Antigen epitope information: N\u2010terminal domain (NTD; 46\u2013176 aa) C\u2010terminal domain (CTD; 247\u2013364 aa)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1060","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Fluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"40","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.71","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.12","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2519","commercial_name":"COVID-19 Antigen Rapid Test (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"835","name":"BIOLAN HEALTH S.L.","country":"Spain","website":"www.biolanhealth.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":"BIOLAN HEALTH COVID-19 Antigen Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleoclapsid antigen of SARS-CoV-2 virus in nasal swab samples in only 15-20 minutes. The product is intended for use as an aid in the rapid diagnosis of COVID-19 in individuals who are suspected of COVID-19 within the first 7 days of symptoms onset or in asymptomatic individuals in line with the in existing national, regional, and local public health and occupational health regulations and recommendations , . This test provides preliminary test results. Positive results indicate the presence of viral antigens, but do not rule out a bacterial infection or co-infection with other viruses. Negative result does not preclude SARS-CoV-2 infection and it cannot be used as a sole basis for diagnosis or patient management decisions. Negative results must be combined with clinical findings, epidemiological information and if necessary, with a molecular test.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2223","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","unit":"TCID50\/ml","info":"3,5 x 10(2,5) "},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.7","unit":"%"},{"parameter":"False negatives","value":"3.5","unit":"%","info":"(within 5 days of sympton onset). "},{"parameter":"False negatives","value":"8.4","unit":"%","info":"(7 days)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.4","unit":"%","info":"(within 5 days of symptom onset). "},{"parameter":"Accuracy","value":"94.4","unit":"%","info":" (7 days)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.5","unit":"%","info":"(within 5 days of symptom onset). "},{"parameter":"Clinical Sensitivity","value":"91.6","unit":"%","info":"( 7 days)"},{"parameter":"Clinical Specificity","value":"98.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2036","commercial_name":"COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"937","name":"BioMaxima SA","country":"Poland","website":"www.biomaxima.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Cat. No. 1-364-K020, the COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1714","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"AU"},{"parameter":"False 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CET","testList":[{"id_test":"1713","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"160","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":"5","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"90","commercial_name":"COVID-19 IgM\/IgG 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The SARS-CoV-2 belongs to a novel coronavirus of genus \u03b2. It has an envelope, the particles are round or oval, often polymorphic, and its diameter is 60-140 nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. SARS-CoV-2 nucleocapsid(N) protein antigen detection is generally used in the acute infection period, and used for sample testing within 7 days of the onset of symptoms in suspected populations. Antigen detection should be used in combination with diagnostic information such as nucleic acid assay and imaging data, and medical history and exposure history to determine the infection status. This product is applicable to the detection of SARS-CoV-2 nucleocapsid(N) protein antigen for people suspected of SARS-CoV-2 infection, and not applicable to the screening of general populations. 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It is also used to monitor the process of different immune stages and evaluate the effect after vaccination. If there is a positive result, it indicates that there may be neutralizing antibody in the sample, but it cannot rule out the false positive caused by inhibitory peptides or small molecule inhibitors. If there is negative result, it indicates that the amount of neutralizing antibody is lower than the detection limit. 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Immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human saliva. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of 'Novel Coronavirus' infection. For in vitro diagnostic use only.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2115","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":"177","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"20","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"91.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"80","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1990","commercial_name":"ichroma\u2122 COVID-19 Ag","manufacturer":{"id_manufacturer":"22","name":"Boditech Med Inc.","country":"South Korea","website":"https:\/\/www.boditech.co.kr\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"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":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""}],"target":["nucleocapsid protein"],"notes":"In the link I have attached, you may see that the sensitivity of iChroma COvid 19 Ag is \"Ct \u2264 25\" The clinical evaluation can be found on the website of FIND : https:\/\/www.finddx.org\/wp-content\/uploads\/2021\/02\/iChroma_Ag-Public-Report_v1_20210223.pdf","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1666","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"12","performances":[{"parameter":"LOD","value":"35.15","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False 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https:\/\/www.btnx.com\/files\/1110032811V5_COVID-19_Antigen_Rapid_Test_Device.pdf","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1018","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":"15","performances":[{"parameter":"LOD","value":"502.38","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"AU"},{"parameter":"False negatives","value":"5","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.2","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2033","commercial_name":"Rapid Response COVID-19 IgG\/IgM Rapid Test Device","manufacturer":{"id_manufacturer":"62","name":"BTNX Inc.","country":"Canada","website":"www.btnx.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":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The Rapid Response COVID-19 IgG\/IgM Rapid Test Device has been CE marked since April of 2020. Since then various independent evaluations have been completed at various EU member state organizations. The \"COVID-19 In Vitro Diagnostic Medical Devices\" mentions that the product is not CE marked. The name of the product has been slightly changed since the first CE marking which could be the cause of this being missed. Could you please check and update the list during the next meeting of JRC? Thank you, Khasim Technical Operations Manager khasim@btnnx.com","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1711","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"210"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"% IgM"},{"parameter":"False positives","value":"3","unit":"% IgG"},{"parameter":"False negatives","value":"5","unit":"% IgM"},{"parameter":"False negatives","value":"1","unit":"% IgG"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.7","unit":"% IgM"},{"parameter":"Accuracy","value":"98.7","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.7","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"98.8","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"99.1","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"98.7","unit":"% IgG"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1647","commercial_name":"AllCheck COVID19 Ag","manufacturer":{"id_manufacturer":"738","name":"CALTH Inc.","country":"South Korea","website":"www.thecalth.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"],"pathogen":["SARS-CoV"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"N\/A","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3668","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"250","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Predict Postivie Value : 100.0% (95% CI : 97.2%~100.0%)"},{"parameter":"False negatives","value":"1.1","unit":"%","info":"Predict Negative Value : 98.9% (95% CI : 97.5%~99.6%))"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"95% CI : 98.4%~99.8%, 650\/656"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%","info":"95% CI : 90.6% ~98.4%, 130\/136"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI : 99.3%~100.0%, 520\/520"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2691","commercial_name":"AllCheck COVID19 Ag Nasal","manufacturer":{"id_manufacturer":"738","name":"CALTH Inc.","country":"South Korea","website":"www.thecalth.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":["SARS-CoV"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3669","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":"10","performances":[{"parameter":"LOD","value":"250","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.8","unit":"%","info":"1 case - Predict Postivie Value : 99.2% (95% CI : 95.6% - 100.0%)"},{"parameter":"False negatives","value":"1.1","unit":"%","info":"6 cases - Predict Negative Value : 98.9% (95% CI : 97.5% - 99.6%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.9","unit":"%","info":"95% CI : 98.1% - 99.7%, 643\/650"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.4","unit":"%","info":"95% CI : 90.2% - 98.3% : 124\/130"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%","info":"95% CI : 98.9% - 100.0% : 519\/520"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1999","commercial_name":"See Now Coronavirus nCoV antigen test","manufacturer":{"id_manufacturer":"918","name":"CAMP MEDICA DISTRIBUTION","country":"Romania","website":"www.campmedica.ro"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal 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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The See Now -Coronavirus nCoV Antigen test is used for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 virus in nasal swabs, nasopharyngeal swabs, oropharyngeal swabs and\/or saliva, from individuals suspected of COVID 19. See Now Coronavirus- nCoV Antigen test cannot be used as the basis to diagnose or exclude SARS-CoV-2 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1676","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"1","unit":"ng\/mL"},{"parameter":"Analytical Sensitivity","value":"97","unit":"%"},{"parameter":"Analytical Specificity","value":"99","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.17","unit":"%"},{"parameter":"Clinical Specificity","value":"99.44","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapside protein"}]}]},{"id_device":"2788","commercial_name":"SARS-CoV-2 Neutralizing Antibodies Test Kit","manufacturer":{"id_manufacturer":"1253","name":"CAS-Envision","country":"China","website":"www.cas-envision.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2493","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"10","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.37","unit":"%","info":"1\/269"},{"parameter":"False negatives","value":"2.59","unit":"%","info":"3\/116"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"5817","commercial_name":"CHECK UP COVID19-INF A\/B-RSV MULTI RAPID TEST KIT","manufacturer":{"id_manufacturer":"1232","name":"Cesna Biyoteknoloji Ara\u00c5\u0178t\u00c4\u00b1rma Geli\u00c5\u0178tirme Laboratuvar Sist.\u00c4\u00b0n\u00c5\u0178.M\u00c3\u00bch.Dan.San.Tic.Ltd.\u00c5\u017eti.","country":"Turkey","website":"www.cesnalaboratuvarsistemleri.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Other"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"In addition, our Covid19 test kit has been published by Common list with RAT number 2696.\r\nWe were verified by PEI in 2021.","last_updated":"2023-01-09 10:08:59 CET","testList":[{"id_test":"5421","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"3200","unit":"TCID50\/ml","info":"for Covid19"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%","info":"for Covid19"},{"parameter":"Analytical Specificity","value":"100","unit":"%","info":"for Covid19"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.33","unit":"%","info":"for Covid19"},{"parameter":"False 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swab"],"pathogen":["Other"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"Our Covid19 clinical assessment was conducted by PEI in 2021.\r\nIn addition, our Covid19 diagnostic kit is on the list with the number of HS common List RAT 2696.","last_updated":"2023-01-09 10:10:16 CET","testList":[{"id_test":"5422","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"3200","unit":"TCID50\/ml","info":"for Covid19"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.32","unit":"%","info":"1 out of 306"},{"parameter":"False negatives","value":"0.49","unit":"%","info":"2 out of 407"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.98","unit":"%","info":"RSV"},{"parameter":"Accuracy","value":"98.18","unit":"%","info":"INFB"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"INFA"},{"parameter":"Accuracy","value":"98.98","unit":"%","info":"Covid19"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.04","unit":"%","info":"InfA"},{"parameter":"Clinical Sensitivity","value":"98.13","unit":"%","info":"INFB"},{"parameter":"Clinical Sensitivity","value":"99.3","unit":"%","info":"Covid19"},{"parameter":"Clinical Sensitivity","value":"99.03","unit":"%","info":"RSV"},{"parameter":"Clinical Specificity","value":"99.01","unit":"%","info":"INFA"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"Covid19"},{"parameter":"Clinical Specificity","value":"99.04","unit":"%","info":"INFB"},{"parameter":"Clinical Specificity","value":"98.04","unit":"%","info":"RSV"}]}]},{"id_device":"5832","commercial_name":"CHECKUP COVID-INF A\/B-RSV-ADENO RAPID TEST KIT","manufacturer":{"id_manufacturer":"1232","name":"Cesna Biyoteknoloji Ara\u00c5\u0178t\u00c4\u00b1rma Geli\u00c5\u0178tirme Laboratuvar Sist.\u00c4\u00b0n\u00c5\u0178.M\u00c3\u00bch.Dan.San.Tic.Ltd.\u00c5\u017eti.","country":"Turkey","website":"www.cesnalaboratuvarsistemleri.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":["Adenovirus","Adenovirus 3","Adenovirus 7","Adenovirus Subtype B","Adenovirus Subtype C","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Anti-Nuclear Antibody","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Bordetella Pertussis","Chlamydia Pneumoniae","Coronaviruses (HCoV)","Cytomegalovirus (CMV)","Enterovirus A71 (EV-A71)","Epstein-Barr Virus (EBV)","Hemophilus Influenzae","Hepatitis A Virus (HAV)","Hepatitis B Virus (HBV)","Hepatitis C Virus (HCV)","Herpes Simplex (HSV)","Human Immunodeficiency Virus (HIV)","Human Metapneumovirus (HMPV)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza A H5N1","Influenza B","Influenza B Victoria","Influenza B Yamagata","MERS-CoV","Mumps Virus (MuV)","Mycobacterium Tuberculosis","Mycoplasma Pneumoniae","Other","Parainfluenza Virus Type","Parainfluenza Virus Type 1","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Respiratory Syncytial V (RSV)","Respiratory Syncytial V (RSV) Type A","Respiratory Syncytial V (RSV) Type B","Rhinovirus","Rhinovirus A","Rhinovirus B","SARS-CoV","SARS-CoV-2","Varicella Zoster Virus (VZV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"last_updated":"2023-01-10 11:26:59 CET","testList":[{"id_test":"5436","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"3200","unit":"TCID50\/ml","info":"(for Covid19)"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"99.01","unit":"%","info":"\u0131nfa"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.32","unit":"%","info":"1 out of 306"},{"parameter":"False negatives","value":"0.49","unit":"%","info":"2 out of 407"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.25","unit":"%","info":"adeno"},{"parameter":"Accuracy","value":"98.18","unit":"%","info":"\u0131nfb"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"\u0131nfa"},{"parameter":"Accuracy","value":"98.98","unit":"%","info":"rsv"},{"parameter":"Accuracy","value":"98.98","unit":"%","info":"covid19"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.03","unit":"%","info":"rsv"},{"parameter":"Clinical Sensitivity","value":"98.04","unit":"%","info":"\u0131nfa"},{"parameter":"Clinical Sensitivity","value":"98.13","unit":"%","info":"\u0131nfb"},{"parameter":"Clinical Sensitivity","value":"99.3","unit":"%","info":"covid19"},{"parameter":"Clinical Sensitivity","value":"99.26","unit":"%","info":"adeno"},{"parameter":"Clinical Specificity","value":"98.04","unit":"%","info":"rsv"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"covid19"},{"parameter":"Clinical Specificity","value":"99.04","unit":"%","info":"\u0131nfb"},{"parameter":"Clinical Specificity","value":"99.06","unit":"%","info":"adeno"}]}]},{"id_device":"2934","commercial_name":"COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1293","name":"Changchun WanCheng Bio Electron Co. Ltd.","country":"China","website":"https:\/\/jlwancheng.en.alibaba.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Saliva","Throat 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For in vitro diagnostic use. 2. This test has been authorized only for the detection of the nucleocapsid protein from SARS- CoV-2, not for any other viruses or pathogens. 3. Do not use this kit beyond the expiration date printed on the outside carton. 4. Test results are meant to be visually determined. 5. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. 6. Do not reuse any kit components. 7. Proper specimen collection is critical to the performance of this test. 8. Dispose of used test kits as biohazards waste in accordance with the local requirements.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2856","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"N.A.","detection_principle":null,"subcategory":null,"time_minutes":"30","notes":"antigen_epi N protein antibody B2 ( MAB2) aa44-aa175 N protein antibody B3 ( MAB3) aa74-aa105","performances":[{"parameter":"LOD","value":"395","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"1.6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.62","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.4","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2766","commercial_name":"Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) (For Nasal)","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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Reagents and devices must be at room temperature (15\u201330 \u00b0C) when used for testing\u3002","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2471","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"170","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.97","unit":"%"},{"parameter":"False negatives","value":"4.35","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.41","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.65","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.03","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2641","commercial_name":"Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)\uff08For Nasal)","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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Reagents and devices must be at room temperature (15\u201330 \u00b0C) when used for testing\u3002","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2346","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"170","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2749","commercial_name":"Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)\uff08For Saliva)\uff09","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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Positive test results do not rule out co-infections with other pathogens. 4.The test results should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient. 5. A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of COVID-19 infection. 6.The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 7 of illness are more likely to be negative compared to a RT-PCR assay. 7.Failure to follow the test procedure may adversely affect test performance and\/or invalid the test result. 8.The contents of this kit are to be used for the qualitative detection of SARS- CoV-2 antigens from saliva swab specimens only","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2454","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"20","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"8.11","unit":"%"},{"parameter":"False negatives","value":"0.8","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.89","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2588","commercial_name":"Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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This test has been authorized only for the detection of the nucleocapsid protein from SARS- CoV-2, not for any other viruses or pathogens. 3. Do not use this kit beyond the expiration date printed on the outside carton. 4. Test results are meant to be visually determined. 5. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. 6. Do not reuse any kit components. 7. Proper specimen collection, storage and transport are critical to the performance of this test 8. The SARS-CoV-2 external positive controls have been prepared from recombinant viral proteins and do not contain infectious material. 9. Dispose of used test kits as biohazards waste in accordance with the local requirements. 10. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS). 11. Wear suitable protection when handling the contents of this kit if it is necessary.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2873","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"170","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.7","unit":"%"},{"parameter":"False negatives","value":"4.4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%"},{"parameter":"Clinical Specificity","value":"98.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2871","commercial_name":"Novel Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"1181","name":"Changzhou Biowin Pharmaceutical Co. 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Reagents and devices must be at room temperature (15\u201330 \u00b0C) when used for testing\u3002","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2576","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"30","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3966","commercial_name":"COVID-19 Antigen Test Cassette","manufacturer":{"id_manufacturer":"16254","name":"Chastru Biotech Limited","country":"China","website":""},"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","Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":["SARS-CoV"],"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":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"last_updated":"2023-03-15 16:34:32 CET","testList":[{"id_test":"20269","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Analytical Sensitivity","value":"97","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"False positives","value":"1","unit":"%"},{"parameter":"False negatives","value":"6","unit":"%"},{"parameter":"Accuracy","value":"99","unit":"%"},{"parameter":"Clinical Sensitivity","value":"97","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"}]}]},{"id_device":"1944","commercial_name":"COVID-19 Antibody Rapid Test Kit (IgG)","manufacturer":{"id_manufacturer":"886","name":"Chongqing iSIA BIO-Technology Co. 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Ltd.","country":"China","website":"www.isiabio.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":["IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"test results good","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1617","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.8","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"AU"},{"parameter":"False negatives","value":"0","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"97","unit":"% IgM"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1937","commercial_name":"COVID-19 Antigen Rapid Test Kit(Swab)","manufacturer":{"id_manufacturer":"886","name":"Chongqing iSIA BIO-Technology Co. Ltd.","country":"China","website":"www.isiabio.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":["Nasal swab","Nasopharyngeal 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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["Other"],"notes":"Befarm list PEI approved","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1613","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"10","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.57","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.06","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2150","commercial_name":"2019-nCoV Antigen Test Kit","manufacturer":{"id_manufacturer":"995","name":"Chongqing M&D Biotechnology Co. Ltd.","country":"China","website":"www.MDfastcheck.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"],"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"}],"target":[],"notes":"The M&D 2019-nCoV Antigen Test Kit is a rapid and convenient lateral flow immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein from nasopharyngeal swab samples obtained from individuals suspected of COVID-19 by their healthcare provider within five-seven days of symptom onset and \/or epidemiological criteria. The rapid test device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-COV-2 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1840","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"8.47","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.11","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.53","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"\uff08Antigen\uff09"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"3142","commercial_name":"COVID-19 and Flu A\/B Multiplex Panel for Home Use (Nasal Swab)","manufacturer":{"id_manufacturer":"659","name":"CITEST DIAGNOSTICS Inc.","country":"Canada","website":"www.citestdiagnostics.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":["Influenza A H1N1","Influenza A H3N2","Influenza B","SARS-CoV"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The COVID-19 and Flu A\/B Multiplex Panel for Home Use (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2, Influenza A and Influenza B virus that causes COVID-19 and\/or Influenza with self-collected nasal swab specimen. The test is intended for use in symptomatic\/asymptomatic individuals who are suspected of being infected with SARS-CoV-2 and\/or Influenza A+B. Results are for the detection of SARS-CoV-2 nucleocapsid protein, Influenza A and Influenza B nucleoproteins antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2 and\/or Influenza A+B. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 and\/or Influenza A+B infection. Individuals who test negative and continue to experience COVID-like or flu-like symptoms should seek follow up care from their healthcare provider. Test for children and young people should be used with an adult. Other pathogens tested for cross-reactivity: pathogens Human Rhinovirus 14,Human Rhinovirus 16,Measles","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2850","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","notes":"The current VOC including Alpha, Beta, Gamma, Delta, Omicron and Omicron BA.2 which will not influence the performance of the Test. antigen_epi NTD (44-180), N-CTD, 209-232a.","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.0285","unit":"AU"},{"parameter":"False negatives","value":"0.0046","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.69","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.15","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.56","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2632","commercial_name":"SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method)","manufacturer":{"id_manufacturer":"1202","name":"Cofoe Medical Technology Co. Ltd.","country":"China","website":"\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"1.When the titer of the SARS-CoV-2 culture is 2.5\u00d7105TCID50\/ml, the test result of this test card does not show a hook effect; when the concentration of the SARS-CoV-2 positive quality control product is within the range of 0.5mg\/ml, the test result of this test card does not show a hook effect . 2.Nasopharyngeal swab specimens can be stored at 2\u2103-8\u2103 for at least 8h. 3.The loading volume of theSARS-CoV-2 antigen test strip is 50\u03bcl. 4.After opening the foil bag, the SARS-CoV-2 antigen test strip meets the requirements within 60 minutes. But the test result will fail after opening for 90 minutes. Therefore, the bag-opening stability is set at 60 minutes. 5.The general storage temperature of the kit is about 25\u00b0C. According to the Arrhenius formula, the logarithm of the expiration date and the reciprocal of the absolute temperature have a linear relationship. Accelerated at 37\u00b0C for 3 months (90 days), converted to approximately 12 months (360 days) stored at 25\u00b0C. Therefore, in the absence of real-time stability test results, it is temporarily assumed that the SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) is valid for 12 months.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2337","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.1","unit":"ng\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.04","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3937","commercial_name":"SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method)","manufacturer":{"id_manufacturer":"3214","name":"Cofoe Medical Technology Co., Ltd.","country":"China","website":""},"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"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus OC43 (HCoV-OC43)","Bordetella Pertussis","Chlamydia Pneumoniae","Hemophilus Influenzae","Influenza A","Influenza A H1N1","Parainfluenza Virus Type","Parainfluenza Virus Type 1","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Respiratory Syncytial V (RSV)","Respiratory Syncytial V (RSV) Type A","Rhinovirus"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"last_updated":"2022-11-14 09:03:04 CET","testList":[{"id_test":"5308","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"900","unit":"TCID50\/ml"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"False positives","value":"0.99","unit":"%"},{"parameter":"False negatives","value":"9.901","unit":"%"},{"parameter":"Accuracy","value":"97.228","unit":"%"},{"parameter":"Clinical Sensitivity","value":"90.099","unit":"%"},{"parameter":"Clinical Specificity","value":"99.01","unit":"%"}]}]},{"id_device":"3011","commercial_name":"Q-Check COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1336","name":"Cold Spring Biotech Corp.","country":"Taiwan ROC","website":"http:\/\/www.csbiotech.com.tw\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Q-Check COVID-19 Antigen Rapid Test is a rapid immunochromatographic method intend for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP)specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2717","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":"15","performances":[{"parameter":"LOD","value":"62.5","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False negatives","value":"6.9","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.6","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.1","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"4068","commercial_name":"Convergys\u00ae COVID-19 Rapid Antigen Test","manufacturer":{"id_manufacturer":"769","name":"Convergent Technologies","country":"Germany","website":"www.convergent-technologies.de"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":["SARS-CoV"],"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":"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"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"last_updated":"2022-09-20 14:36:35 CET","testList":[{"id_test":"3830","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"180","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"95","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.98","unit":"%"},{"parameter":"False negatives","value":"4.97","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.15","unit":"%"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.03","unit":"%"},{"parameter":"Clinical Specificity","value":"99.02","unit":"%"}]}]},{"id_device":"2505","commercial_name":"Canea COVID-19 Antigen Speichel Selbsttest","manufacturer":{"id_manufacturer":"1142","name":"Core Technology Co. Ltd.","country":"China","website":"http:\/\/www.coretests.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["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":"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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label the COVID-19 monoclonal antibody. Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2209","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"22.5","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"100","unit":"%"},{"parameter":"False negatives","value":"100","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.7","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.6","unit":"%"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1919","commercial_name":"Coretests COVID-19 Ag Test","manufacturer":{"id_manufacturer":"420","name":"Core Technology Co. Ltd.","country":null,"website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Bordetella Pertussis","Chlamydia Pneumoniae","Hemophilus Influenzae","Human Metapneumovirus (HMPV)","Influenza A H1N1","Influenza A H3N2","Influenza A H5N1","Influenza B Victoria","Influenza B Yamagata","MERS-CoV","Mycobacterium Tuberculosis","Mycoplasma Pneumoniae","Other","Parainfluenza Virus Type 1","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Respiratory Syncytial V (RSV) Type A","Rhinovirus","SARS-CoV"],"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":"1137","lineage_name":"B.1.429","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":"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"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"COVID-19 Ag Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasopharyngeal swab \/ oropharyngeal swab \/ nasal swab specimen. This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody, using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the COVID-19 antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain COVID-19 antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area. Regardless of the presence of COVID-19 antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as 1.verification that sufficient volume is added. 2.That proper flow is obtained 3. And as a control for the reagents.","last_updated":"2022-10-31 09:12:45 CET","testList":[{"id_test":"5253","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"22.5","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%"},{"parameter":"False negatives","value":"18","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"91.09","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"82","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"3025","commercial_name":"Coretests \u00ae COVID-19 Ag Test","manufacturer":{"id_manufacturer":"420","name":"Core Technology Co. 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Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the COVID-19 antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain COVID-19 antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area .Regardless of the presence of COVID-19 antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as 1.verification that sufficient volume is added. 2.That proper flow is obtained 3. 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disease","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2160","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"800","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"None"},{"parameter":"False negatives","value":"0","unit":"%","info":"None"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"98","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"3001","commercial_name":"QuantiVirus SARS-CoV-2 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1328","name":"Diacarta Inc.","country":"United States","website":"https:\/\/www.diacarta.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["non-structural protein NSP1","non-structural protein NSP2","non-structural protein NSP3","non-structural protein NSP4","non-structural protein NSP5"],"notes":"N\/A","last_updated":"2022-08-24 09:08:01 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The spike protein is the most important surface membrane protein of the novel coronavirus, which undertakes the function of binding the virus to the host cell membrane receptor and membrane fusion, and is an important site for host neutralizing antibodies. The SARS-CoV-2 neutralizing antibody can prevent the receptor binding domain (RBD) protein from binding to ACE2, thereby blocking the virus from contacting the host cell, and ultimately preventing the virus infection. This reagent uses the principle of colloidal gold immunochromatography to detect SARS-CoV-2 neutralizing antibodies in samples. The kit does not need to be carried out in the biosafety level 3 laboratory (BSL-3). It has the advantages of simple operation, strong specificity, high safety and low cost, and can realize rapid detection","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2195","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"9.3","unit":"%"},{"parameter":"False negatives","value":"1.36","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.74","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.7","unit":"%"},{"parameter":"Clinical Specificity","value":"98.63","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2955","commercial_name":"COVID-19 Neutralizing Antibody Testing Cassette(GICA)\/COVID-19 Antigen Testing Cassette(GICA)","manufacturer":{"id_manufacturer":"1303","name":"DN Laboratory Co. Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual","Semi-automated"],"target_type":["Antibody","IgG","IgM","IgA","Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"COVID-19 Antigen Testing Cassette (GICA):The Reagent Kit can be used for a qualitative test of COVID-19 antigens in human nasopharyngeal swab and oropharyngeal swab samples in vitro, which is beneficial to the auxiliary examination of patients suffering from pneumonia caused by COVID-19 infection. COVID-19 neutralizing antibody testing cassette (GICA):The Reagent Kit can be used for a qualitative test of COVID-19 neutralizing antibodies in human serum, plasma or whole blood samples in vitro.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2661","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":"Yes","reader_required":"Yes","method":"Immunochromatography","measurement":"Semiquantitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"the positive coincidence rate should be (+\/+) 5\/5"},{"parameter":"False negatives","info":"he negative coincidence rate should be (-\/-) 10\/10"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"% IgG"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"}]}]},{"id_device":"2242","commercial_name":"COVID-19 Antigen Detection Kit","manufacturer":{"id_manufacturer":"1042","name":"DNA Diagnostic","country":"Denmark","website":"https:\/\/dna-diagnostic.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":[{"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"}],"target":["nucleocapsid protein"],"notes":"No additional information","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1943","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"160","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.44","unit":"%","info":"1 out of 226 true negatives compared to PCR"},{"parameter":"False negatives","value":"6.25","unit":"%","info":"9 out of 144 true positives compared to PCR"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.3","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"93.8","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2273","commercial_name":"Dr\u00e4ger Antigen Test SARS-CoV-2","manufacturer":{"id_manufacturer":"1060","name":"Dr\u00c3\u00a4ger Safety AG & Co. KGaA","country":"Germany","website":"www.draeger.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"LOD is 200 pg\/Test; Osmanodja, B. et al. (2021) \u2018Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs\u2019, Journal of Clinical Medicine, 10(10), p. 2099. doi: 10.3390\/jcm10102099. Clinical Validation at Charit\u00e9, Berlin, Germany","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1974","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"200","unit":"pg"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"96.8","unit":"%","info":" (Ct values < 26)"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.32","unit":"%","info":"1 out of 308 samples (symptomatic and asymptomatic PCR negative)"},{"parameter":"False negatives","value":"10.1","unit":"%","info":"7 out of 69 samples (symptomatic PCR positive)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.9","unit":"%","info":"Ct values < 26"},{"parameter":"Accuracy","value":"97.1","unit":"%","info":"overall"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.8","unit":"%","info":"Ct values < 26"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2647","commercial_name":"Dr\u00e4ger COVID-19 Home Test","manufacturer":{"id_manufacturer":"1209","name":"Dr\u00c3\u00a4ger Safety AG & Co. 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This update is based on a recent update of the corresponding technical documentation. ID2647 is the home-use version of the professional test ID2273. We have submitted an update to its section on detected virus variants, too. 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Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"antigen_epi Clone #2F4 for gold dye, Clone #3C3 for capture(membrane). Based on the Epitope Mapping Results, the target epitope is presented below; (Reference: NCBI Reference Sequence ID: NC_045512.2, Domain CDS 28274 to 29533; Nucleocapsid phosphoprotein) 1) Clone #2F4 258P, 260Q, 261K, 262R, 263T, 264A. 265T, 266K, 269N, 273A, 286F, 294Q, 296T, 297D, 298Y, 302P, 305A, 306Q, 311A, 312S, 313A, 316G, 335G, 340D, 343D, 356H 2) Clone #3C3 3D, 114G, 262R, 264A, 322M, 323E, 324V, 325T, 326P, 329T, 335G, 340D, 346F, 348D, 350V, 355K, 365P -Conclusion Both #2F4 and #3C3 recognize conformational epitope as below; #2F4 : PQKRTTKNAQTDYPAQASAGGDDH #3C3 : DGRAMEVTPTGDFDVKP","performances":[{"parameter":"LOD","value":"507","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.91","unit":"%","info":"3\/103"},{"parameter":"False negatives","value":"0","unit":"%","info":"0\/301"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.26","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.09","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"4081","commercial_name":"GB COVID-19 Ag POCT","manufacturer":{"id_manufacturer":"104","name":"General Biologicals Corporation","country":"Taiwan ROC","website":"www.gbc.com.tw\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["SARS-CoV","SARS-CoV-2"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"last_updated":"2022-09-20 14:54:12 CET","testList":[{"id_test":"20270","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"84","unit":"%"},{"parameter":"Analytical Specificity","value":"98.14","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.8","unit":"%"},{"parameter":"False negatives","value":"16","unit":"%"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"94.8","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"84","unit":"%"},{"parameter":"Clinical Specificity","value":"98.14","unit":"%"}]}]},{"id_device":"3075","commercial_name":"Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Lateral Flow Assay)","manufacturer":{"id_manufacturer":"1362","name":"GeneSign Biotech (Xiamen) Co. 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German Paul-Ehrlich-Institur (PEI) evaluated this test under the test-ID AT 1269\/21","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2857","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"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 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Results are for the detection of SARS-CoV-2 Nucleocapsid protein and Influenza A+B Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2\/ Influenza A+B infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2\/ Influenza A+B.","last_updated":"2022-09-20 17:19:37 CET","testList":[{"id_test":"20281","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":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU","info":"Evaluated"},{"parameter":"False positives","value":"0.003","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"False positives","value":"0.018","unit":"%","info":"Influenza A+B Test"},{"parameter":"False negatives","value":"0.024","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"False negatives","value":"0.053","unit":"%","info":"Influenza A+B Test"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"Accuracy","value":"97.7","unit":"%","info":"Influenza A+B Test"},{"parameter":"Clinical Sensitivity","value":"97.6","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"Clinical Sensitivity","value":"94.7","unit":"%","info":"Influenza A+B Test"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"SARS-CoV-2 Test"},{"parameter":"Clinical Specificity","value":"98.2","unit":"%","info":"Influenza A+B Test"}]}]},{"id_device":"1946","commercial_name":"SARS-COV-2 rapid antigen test (Swab)","manufacturer":{"id_manufacturer":"126","name":"Hangzhou AllTest Biotech Co. Ltd.","country":"China","website":"www.alltests.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":["Nasal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1622","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.006","unit":"AU"},{"parameter":"False negatives","value":"0.066","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2897","commercial_name":"Novel Coronavirus (SARS-CoV-2 ) Antigen Rapid Test(Colloidal Gold)","manufacturer":{"id_manufacturer":"127","name":"Hangzhou Bigfish Bio-tech Co. Ltd.","country":"China","website":"www.bigfishgene.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"1. Store at 4~30\u2103 out of direct sunlight, and it is valid for 24 months from Production Date. 2. Keep dry, and do not use frozen and expired devices. 3. Test cassette should be used within half 1 hour once opening the Aluminum foil pouch. 4. Store the buffer at 4~30\u2103, and it should be use within 3 months after opening.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2602","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"30","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"99.25","unit":"%"},{"parameter":"False positives","value":"98.94","unit":"%"},{"parameter":"False positives","value":"99.64","unit":"%"},{"parameter":"False negatives","value":"95.08","unit":"%","info":"In the clinical study, the PPA for three swabs are "},{"parameter":"False negatives","value":"94.58","unit":"%","info":"In the clinical study, the PPA for three swabs are 95.08%, 94.58% and 93.81%."},{"parameter":"False negatives","value":"93.81","unit":"%","info":"In the clinical study, the PPA for three swabs are 95.08%, 94.58% and 93.81%."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.32","unit":"%","info":"Antigen, Oropharyngeal Swab"},{"parameter":"Accuracy","value":"97.55","unit":"%","info":"Antigen, Nasopharyngeal Swab"},{"parameter":"Accuracy","value":"97.26","unit":"%","info":"Antigen, Anterior Nasal swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.86","unit":"%","info":"Antigen, Nasopharyngeal Swab"},{"parameter":"Clinical Sensitivity","value":"98.13","unit":"%","info":"Antigen, Oropharyngeal Swab"},{"parameter":"Clinical Sensitivity","value":"99.45","unit":"%","info":"Antigen, Anterior Nasal swab"},{"parameter":"Clinical Specificity","value":"96.7","unit":"%","info":"Antigen, Nasopharyngeal Swab"},{"parameter":"Clinical Specificity","value":"96.88","unit":"%","info":"Antigen, Oropharyngeal Swab"},{"parameter":"Clinical Specificity","value":"95.88","unit":"%","info":"Antigen, Anterior Nasal swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2058","commercial_name":"SARS-CoV-2 Antigen Test Kit (colloidal gold method)","manufacturer":{"id_manufacturer":"949","name":"Hangzhou Bioer Technology Co. Ltd.","country":"China","website":"http:\/\/www.bioer.com.cn\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":[],"notes":"http:\/\/www.bioer.com.cn\/en\/","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1738","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1.75","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%"},{"parameter":"False negatives","value":"4.6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2059","commercial_name":"SARS-CoV-2 IgM\/IgG Antibody Test Kit (colloidal gold method)","manufacturer":{"id_manufacturer":"949","name":"Hangzhou Bioer Technology Co. Ltd.","country":"China","website":"http:\/\/www.bioer.com.cn\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":[],"notes":"http:\/\/www.bioer.com.cn\/en\/ LoD: 250U\/mL","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1739","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"250"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.3","unit":"%"},{"parameter":"False negatives","value":"4.9","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.3","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"4120","commercial_name":"COVID-19 + Flu A&B + RSV Antigen Combo  Rapid Test Cassette\uff08Nasal Swab\uff09","manufacturer":{"id_manufacturer":"128","name":"Hangzhou Biotest Biotech Co. Ltd.","country":"China","website":"en.biotests.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":["Nasal swab"],"pathogen":["Influenza A","Influenza B","Respiratory Syncytial V (RSV)","SARS-CoV-2"],"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":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"last_updated":"2022-10-31 09:32:55 CET","testList":[{"id_test":"5264","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"98.17","unit":"%"},{"parameter":"Analytical Specificity","value":"99.61","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"%","info":"2 false positive result is observed in 109 negative samples confirmed by RT-PCR"},{"parameter":"False negatives","value":"1","unit":"%","info":"1 false negative results are observed in 260 positive samples confirmed by RT-PCR"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.18","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.17","unit":"%"},{"parameter":"Clinical Specificity","value":"99.61","unit":"%"}]}]},{"id_device":"24752","commercial_name":"COVID-19 + Flu A&B +RSV Antigen Combo Rapid Test Cassette\uff08Nasal Swab \/Nasopharyngeal Swab\uff09","manufacturer":{"id_manufacturer":"128","name":"Hangzhou Biotest Biotech Co. Ltd.","country":"China","website":"en.biotests.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":["Nasal swab","Nasopharyngeal swab"],"pathogen":["Influenza A","Influenza B","Respiratory Syncytial V (RSV)","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":"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":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["Other"],"last_updated":"2023-03-14 11:19:31 CET","testList":[{"id_test":"20264","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"1000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"93.64","unit":"%"},{"parameter":"Analytical Specificity","value":"96.67","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"9","unit":"tests","info":"Tested 270 negative samples, 9 samples are false positive."},{"parameter":"False negatives","value":"7","unit":"tests","info":"Tested 110 positive samples, 7 samples are false negative. "},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.79","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.64","unit":"%"},{"parameter":"Clinical Specificity","value":"96.67","unit":"%"}]}]},{"id_device":"24751","commercial_name":"COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette\uff08Nasal Swab \/Nasopharyngeal Swab\uff09","manufacturer":{"id_manufacturer":"128","name":"Hangzhou Biotest Biotech Co. Ltd.","country":"China","website":"en.biotests.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":["Nasal swab","Nasopharyngeal swab"],"pathogen":["Influenza A","Influenza B","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":"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":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["Other"],"last_updated":"2023-03-14 11:19:08 CET","testList":[{"id_test":"20263","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"1000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"93.64","unit":"%"},{"parameter":"Analytical Specificity","value":"96.67","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"9","unit":"tests","info":"Tested 270 samples, 9 samples is false positive"},{"parameter":"False negatives","value":"7","unit":"tests","info":"Tested 110 samples, 7 samples is false negative."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.79","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.64","unit":"%"},{"parameter":"Clinical Specificity","value":"96.67","unit":"%"}]}]},{"id_device":"4119","commercial_name":"COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette\uff08Nasal Swab\uff09","manufacturer":{"id_manufacturer":"128","name":"Hangzhou Biotest Biotech Co. Ltd.","country":"China","website":"en.biotests.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":["Nasal swab"],"pathogen":["Influenza A","Influenza B","SARS-CoV-2"],"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":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"last_updated":"2022-10-31 09:32:33 CET","testList":[{"id_test":"5263","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"99.2","unit":"%"},{"parameter":"Analytical Specificity","value":"99.47","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"1 false positive result is observed in 125 negative samples confirmed by RT-PCR"},{"parameter":"False negatives","value":"2","unit":"%","info":"2 false negative results are observed in 380 positive samples confirmed by RT-PCR"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.41","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.2","unit":"%"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%"}]}]},{"id_device":"4121","commercial_name":"COVID-19 + Flu A&B+ RSV+ Adenovirus   Antigen Combo Rapid Test Cassette  \uff08Nasal Swab\uff09","manufacturer":{"id_manufacturer":"128","name":"Hangzhou Biotest Biotech Co. Ltd.","country":"China","website":"en.biotests.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":["Nasal swab"],"pathogen":["Adenovirus","Influenza A","Influenza B","Respiratory Syncytial V (RSV)","SARS-CoV-2"],"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":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"last_updated":"2022-10-31 09:33:20 CET","testList":[{"id_test":"5265","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"98.17","unit":"%"},{"parameter":"Analytical Specificity","value":"99.61","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"%","info":"2 false positive result is observed in 109 negative samples confirmed by RT-PCR"},{"parameter":"False negatives","value":"1","unit":"%","info":"1 false negative results are observed in 260 positive samples confirmed by RT-PCR"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.18","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.17","unit":"%"},{"parameter":"Clinical Specificity","value":"99.61","unit":"%"}]}]},{"id_device":"4110","commercial_name":"COVID-19 Antigen Rapid Test Cassette   (Saliva\/Nasal Swab)","manufacturer":{"id_manufacturer":"128","name":"Hangzhou Biotest Biotech Co. 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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"}]}]},{"id_device":"3136","commercial_name":"COVID-19 Antigen Rapid Test (self test)","manufacturer":{"id_manufacturer":"413","name":"Hangzhou Clongene Biotech Co. 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Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Sensitivity, specificity and accuracy are from the newest performance evaluation - including false-positives and false-negatives. 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":"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":"1446","commercial_name":"COVID-19 Antigen Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"1191","name":"Hangzhou Singclean Medical Products Co. 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Ltd.","country":"China","website":"www.singclean.net"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":["Antigen"],"specimen":["Nasal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"Bfarm list AT 1013\/21 The specimen was Nasal swab.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2314","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"9.75","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%"},{"parameter":"False negatives","value":"2.78","unit":"%"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98.63","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.22","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1974","commercial_name":"Singclean","manufacturer":{"id_manufacturer":"1191","name":"Hangzhou Singclean Medical Products Co. Ltd.","country":"China","website":"www.singclean.net"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Bfarm list AT 437\/21","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1650","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"9.975","unit":"U\/ml","info":"[LOD (U\/ml)=9.975 x 102 TCID50\/mL]"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"The results of test reagent and control reagent both were 309 negative specimens, there are three sp"},{"parameter":"False negatives","info":"The results of test reagent and control reagent both were 209 positive specimens, there are three sp"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98.84","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.56","unit":"%"},{"parameter":"Clinical Specificity","value":"99.03","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"24766","commercial_name":"SARS-CoV-2 Antigen Test\uff08nasopharyngeal swab\uff09","manufacturer":{"id_manufacturer":"17328","name":"Hangzhou Tongzhou Biotechnology Co Ltd","country":"China","website":"www.tongzhoubio.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"],"pathogen":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza A H5N1","Influenza B","MERS-CoV","Mumps Virus (MuV)","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"The SARS-CoV-2 Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasopharyngeal swab specimens.\r\nResults are for the identification of SARS-CoV-2 nucleocapsid protein antigen. \r\nAntigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co\u0002infection with other viruses. The agent detected may not be the definite cause of \r\ndisease.\r\nNegative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions including infection control decisions. \r\nNegative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.\r\nIndividuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.","last_updated":"2023-07-27 10:46:07 CET","testList":[{"id_test":"21091","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"N.A.","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Analytical Specificity","value":"99.3","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.066","unit":"AU"},{"parameter":"False negatives","value":"0.007","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"}]}]},{"id_device":"2942","commercial_name":"SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette (Swab)","manufacturer":{"id_manufacturer":"1298","name":"Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd.","country":"China","website":"https:\/\/www.zdbiogene.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"none","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2648","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"4.86","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.07","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.14","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2362","commercial_name":"CLINITEST\u00ae Rapid COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"1092","name":"Healgen","country":"United States","website":"healgen.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","Nasopharyngeal swab"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":[],"notes":"The RAT is already registered at https:\/\/covid-19-diagnostics.jrc.ec.europa.eu\/devices\/detail\/1767 - however with another name. To be able of using the RAT in Switzerland as an aid for the COVID-Certificate i was told it needs to have the exact same name. As the RAT with ID 1767 doesn't have the same name, eventhough it's the same test, herbey the application. If it is possible to add the name to 1767 it will work for Switzerland as well, I guess. Otherwise it needs to be added. Thank you and best regards Kristian Palas","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2063","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1.15","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"sensitivity: 98.32% specificity: 99.6%"},{"parameter":"False negatives","info":"sensitivity: 98.32% specificity: 99.6%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.73","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2238","commercial_name":"Clinitest Rapid Covid-19 Antigen Self Test","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.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":[{"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":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"n\/a","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1939","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"115"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"97.25% Sensitivity, 100% Specificity"},{"parameter":"False negatives","info":"97.25% Sensitivity, 100% Specificity"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98.73","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.25","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2737","commercial_name":"CLINITEST\u00ae Rapid COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.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","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Rationale: Updating already-existing listing to correct the manufacturer and antigen type","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2442","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":"15","performances":[{"parameter":"Accuracy","value":"99.42","unit":"%","info":"nasopharyngeal swab"},{"parameter":"Accuracy","value":"98.73","unit":"%","info":"nasal swab"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%","info":"nasopharyngeal swab"},{"parameter":"Clinical Sensitivity","value":"97.25","unit":"%","info":"nasal swab"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":"nasopharyngeal swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"nasal swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1767","commercial_name":"Coronavirus Ag Rapid Test Cassette","manufacturer":{"id_manufacturer":"554","name":"Healgen Scientific","country":"United States","website":"https:\/\/www.healgen.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":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1446","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Accuracy","value":"98.73","unit":"%","info":"Nasal swab"},{"parameter":"Accuracy","value":"99.42","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Sensitivity","value":"97.25","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":"Nasopharyngeal swab"}]}]},{"id_device":"2974","commercial_name":"Healfo SARS-CoV-2 Ag Saliva Rapid Test","manufacturer":{"id_manufacturer":"1313","name":"Healvet Medtech GZ Ltd.","country":"China","website":"http:\/\/www.hnhealfo.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Oropharyngeal swab","Saliva"],"pathogen":["SARS-CoV"],"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":"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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":[],"notes":"1. False negative results can occur if the saliva is not collected properly. 2. Do not eat or drink any things for 2 hours before the test.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2680","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","performances":[{"parameter":"LOD","info":"For in vitro diagnostic use."},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.85"},{"parameter":"False negatives","value":"6.6"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.3"},{"parameter":"Clinical Specificity","value":"99.1"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1637","commercial_name":"SARS-CoV-2 IgM\/IgG Antibody Test Kit (Colloidal Gold Method)","manufacturer":{"id_manufacturer":"733","name":"Hefei Biohit Healthcare","country":"China","website":"www.biouhan.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":["Plasma","Serum","Whole blood"],"pathogen":["Anti-Nuclear Antibody","Hemophilus Influenzae","Hepatitis B Virus (HBV)","Hepatitis C Virus (HCV)","Influenza A","Influenza B","Respiratory Syncytial V (RSV)"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein","spike protein"],"notes":"The SARS-CoV-2 IgM\/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, K2-EDTA, and sodium citrate), and whole blood (heparin, K2-EDTA, sodium citrate, and no anticoagulant).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1317","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"14","performances":[{"parameter":"LOD","value":"10","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.4","unit":"% IgG"},{"parameter":"Accuracy","value":"99.1","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.66","unit":"% IgM"},{"parameter":"Clinical Sensitivity","value":"99.46","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"98.66","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1929","commercial_name":"Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"883","name":"Hoyotek Biomedical Co. Ltd.","country":"China","website":"http:\/\/hoyotek.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Influenza A","Influenza A H3N2","Influenza B","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Rhinovirus"],"lineage":[{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein","Other"],"notes":"The nasal swab model of the product has been evaluated by Braizil lab and Thai RAMA Hospital. For Braizil lab: Sensitivity 97.1%, For RAMA hospital Sensitivity 95%, specificity 100%","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1605","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"13","notes":"antigen_epi: 45-181aa. Other pathogens tested for cross-reactivity: MERS-coronavirus,Adenovirus 71,Human Metapneumovirus,Enterovirus,RStreptococcus pneumoniae,espiratory syncytial virus A,Rhinovirus,Haemophilus influenza,Streptococcus pneumoniae","performances":[{"parameter":"LOD","value":"200","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"Nasopharyngeal swab\/Antigen"},{"parameter":"False positives","value":"2.5","unit":"%","info":"Oropharyngea swab\/Antigen"},{"parameter":"False positives","value":"5.45","unit":"%","info":"Nasal swab"},{"parameter":"False negatives","value":"4","unit":"%","info":"Nasopharyngeal swab\/Antigen"},{"parameter":"False negatives","value":"7","unit":"%","info":"Oropharyngea swab\/Antigen"},{"parameter":"False negatives","value":"0.21","unit":"%","info":"Nasal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"Nasopharyngeal swab\/Antigen"},{"parameter":"Accuracy","value":"98.79","unit":"%","info":"Nasal swab"},{"parameter":"Accuracy","value":"94.8","unit":"%","info":"Oropharyngea swab\/Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%","info":"Oropharyngea swab"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Sensitivity","value":"94.55","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Specificity","value":"97.5","unit":"%","info":"Oropharyngea swab"},{"parameter":"Clinical Specificity","value":"99.79","unit":"%","info":"Nasal swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein, Other"}]}]},{"id_device":"1931","commercial_name":"Influenza A\/B\/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)","manufacturer":{"id_manufacturer":"883","name":"Hoyotek Biomedical Co. Ltd.","country":"China","website":"http:\/\/hoyotek.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[],"target":["Other"],"notes":"The product is based on the principle of sandwich and colloidal gold immunochromatography, the nitrocellulose membrane Test Zone is pre-coated with mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody, the Control Zone is pre-coated with goat anti-mouse polyclonal antibody, the gold conjugation pad is pre-coated with colloidal gold labeled mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody. When testing positive samples, Influenza A\/B\/COVID-19 Antigen the sample will be combined with colloidal gold (Au) labeled mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody and form into immune complexes (Au-mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody-[ Influenza A\/B\/COVID-19- (Antigen)]), the complexes will move forward inside the nitrocellulose membrane by chromatography effect. When reaching Test Zone, the complexes will be combined with mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody, and form into \u201c(Au-mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody-[COVID-19- (Antigen)])-[ mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody]\u201d, thus agglutination color appears; The residual colloidal gold labeled mouse anti-Influenza A\/B\/Corona Virus (COVID-19) monoclonal antibody will be combined with goat anti-mouse polyclonal antibody at the Control Zone, and produce color under agglutination. When testing negative samples, there\u2019s no Influenza A\/B\/COVID-19 Antigen in the samples, no immune complexes will be formed and color only appears in the Control line.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1607","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"5.25","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"COVID-19"},{"parameter":"False positives","value":"1.5","unit":"%","info":"FluB"},{"parameter":"False positives","value":"2","unit":"%","info":"FluA"},{"parameter":"False negatives","value":"4","unit":"%","info":"COVID-19"},{"parameter":"False negatives","value":"8","unit":"%","info":"FluB"},{"parameter":"False negatives","value":"6","unit":"%","info":"FluA"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.5","unit":"%","info":"FluA"},{"parameter":"Accuracy","value":"95.3","unit":"%","info":"FluB"},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"COVID-19"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%","info":"FluA"},{"parameter":"Clinical Sensitivity","value":"92.1","unit":"%","info":"FluB"},{"parameter":"Clinical Sensitivity","value":"96","info":"COVID-19"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":"FluA"},{"parameter":"Clinical Specificity","value":"98.5","unit":"%","info":"FluB"},{"parameter":"Clinical Specificity","value":"99","info":"COVID-19"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"3562","commercial_name":"Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) - self-testing","manufacturer":{"id_manufacturer":"1418","name":"Hoyotek Biomedical Co.,Ltd,","country":"China","website":"http:\/\/hoyotek.cn\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["Adenovirus","Alpha Coronavirus 229E (HCoV-229E)","Influenza A","Influenza A H3N2","Influenza B","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Rhinovirus"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3280","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"13","performances":[]}]},{"id_device":"1748","commercial_name":"2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25","manufacturer":{"id_manufacturer":"780","name":"Huachenyang (Shenzhen) Technology Co. 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Ltd.","country":"South Korea","website":"http:\/\/www.humasis.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"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":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["Other"],"notes":"Celltrion DiaTrustTM COVID-19 Ag Rapid Test is designed for qualitative detection of SARS-CoV-2 antigens in nasopharyngeal and nasal swab specimen of symptomatic patients suspected of COVID-19 [ MATERIAL COMPOSITION ] \u25cf Monoclonal antibody to SARS-CoV-2 Nucleocapsid \u25cf Monoclonal antibody specific to RBD of SARS-CoV-2 Spike Protein \u25cf Goat anti-mouse IgG Celltrion DiaTrust COVID-19 Ag Rapid Test: Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use. EUA Number: EUA210190","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2340","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"32","unit":"TCID50\/ml","info":"5 x 100.8 TCID50\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Unknown"},{"parameter":"False negatives","info":"Unknown"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","info":"Unknown"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"92","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"5719","commercial_name":"Celltrion DiaTrust\u2122 COVID-19 IgG\/IgM Rapid Test","manufacturer":{"id_manufacturer":"1062","name":"Humasis Co. Ltd.","country":"South Korea","website":"http:\/\/www.humasis.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":["Other"],"lineage":[{"id_lineage":null,"lineage_name":"Other","lineage_country":null}],"target":["Other"],"last_updated":"2022-10-18 08:52:01 CET","testList":[{"id_test":"5210","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"%"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"% IgM"},{"parameter":"Clinical Sensitivity","value":"92","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"98.7","unit":"%","info":"% IgM"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"}]}]},{"id_device":"2276","commercial_name":"Humasis COVID-19 Ag Home Test","manufacturer":{"id_manufacturer":"1062","name":"Humasis Co. Ltd.","country":"South Korea","website":"http:\/\/www.humasis.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1977","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"%"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"5.6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.3","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1263","commercial_name":"Humasis COVID-19 Ag Test","manufacturer":{"id_manufacturer":"1062","name":"Humasis Co. 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CET","testList":[{"id_test":"1470","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Chemiluminescence","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"3.22","unit":"IU\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"AU"},{"parameter":"False negatives","value":"0","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.72","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.5","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1421","commercial_name":"SCoV-2 Ag Detect  Rapid Test","manufacturer":{"id_manufacturer":"139","name":"InBios 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It will provide information for clinical doctors to prescribe correct medications.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2033","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.9","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.57","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2278","commercial_name":"Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)","manufacturer":{"id_manufacturer":"1063","name":"Innovation Biotech(Beijing) Co. 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The result of this test should not be the sole basis for the diagnosis; con\ufb01rmatory testing is required","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1979","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5.26","unit":"AU"},{"parameter":"False negatives","value":"1","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.21","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2331","commercial_name":"Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)","manufacturer":{"id_manufacturer":"1084","name":"Innovation Biotech(Beijing) Co. 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The result of this test should not be the sole basis for the diagnosis; con\ufb01rmatory testing is required","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2032","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5.26","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.21","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2565","commercial_name":"InnoScreenTM COVID-19 IgG\/IgM Rapid Test Device","manufacturer":{"id_manufacturer":"1169","name":"Innovation Scientific Pty Ltd.","country":"Australia","website":"www.innovationsci.com.au"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Peripheral blood","Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"Sensitivity, Specificity and Accuracy may vary depending on samples cohort","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2270","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.1","unit":"%","info":"(less than 0.1%)"},{"parameter":"False negatives","value":"5","unit":"%","info":"(less than 5%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"90","unit":"%","info":"(>90%)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90","unit":"%","info":"(>90%)"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%","info":"(>99.9%)"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2531","commercial_name":"2019-nCoV Neutralizing Antibody Test (Quantum Dot Immunofluorescence Chromatography)","manufacturer":{"id_manufacturer":"1144","name":"INNOVITA (Tangshan) Biological Technology Co. 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09:08:01 CET","testList":[{"id_test":"2235","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.3","unit":"%"},{"parameter":"False negatives","value":"8.4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.6","unit":"%"},{"parameter":"Clinical Specificity","value":"96.7","unit":"%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"3084","commercial_name":"AQ+ COVID-19 Ag Rapid Test","manufacturer":{"id_manufacturer":"147","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.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":["Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Chlamydia Pneumoniae","Influenza A H1N1","Influenza A H3N2","Influenza B Yamagata","MERS-CoV","Mycobacterium Tuberculosis","Mycoplasma Pneumoniae","Parainfluenza Virus Type 1","Respiratory Syncytial V (RSV) Type A"],"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":"1137","lineage_name":"B.1.429","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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"Other lineages detected: \tDelta-Plus(AY.1).     other pathogens tested for cross-reactivity: H7N9 avian influenza virus, Mycobacterium tuberculosis, Legionella, Streptococcus pneumoniae, Enterovirus A(CV-A10), Enterovirus B (Enterovirus 6), Staphylococcus aureus","last_updated":"2023-02-01 14:56:31 CET","testList":[{"id_test":"5460","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"160","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.2","unit":"%","info":"1 in 494 cases"},{"parameter":"False negatives","value":"3.14","unit":"%","info":"14 in 446 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.86","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3098","commercial_name":"AQ+ COVID-19 Ag Rapid Test","manufacturer":{"id_manufacturer":"1107","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.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":[{"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The AQ+ COVID-19 Ag Rapid Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. This test is for self-testing. The test is for self-test with self-collected anterior nasal swab samples. It is for individuals aged 18 years or older who are asymptomatic or have symptoms of COVID-19 within the first seven (7) days. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2804","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Other variants detected: Delta-Plus(AY.1), Natural Wild Variant","performances":[{"parameter":"LOD","value":"160","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.91","unit":"%","info":"1 in 110 cases"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 in 470 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.83","unit":"%","info":"95%CI: 99.04%-100.00%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.09","unit":"%","info":"95%CI: 95.04%-99.98%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95%CI: 99.22%-100.00%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2484","commercial_name":"Rapid SARS-CoV-2 Antigen Test","manufacturer":{"id_manufacturer":"147","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.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":[{"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. This test is for self-testing. The test is for self-test with self-collected anterior nasal swab samples. It is indicated for the use of individuals aged 18 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2187","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Other variants detected: Delta-Plus (AY.1), Natural Wild Variant.  Other pathogens tested for cross-reactivity: H7N9 avian influenza virus, Legionella, Streptococcus Pneumoniae, Enterovirus A, Enterovirus B, Staphylococcus aureus","performances":[{"parameter":"LOD","value":"425","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6.36","unit":"%","info":"7 in 110 cases"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 in 470 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.79","unit":"%","info":"95%CI: 97.53%-99.51%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.64","unit":"%","info":"95%CI: 87.33%-97.40%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95%CI: 99.22%-100.00%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2419","commercial_name":"Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen)","manufacturer":{"id_manufacturer":"1107","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.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"],"pathogen":[],"lineage":[],"target":[],"notes":"PEI positive evaluated, Test-ID AT574\/21.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2121","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"425","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6.93","unit":"%","info":"7 false positives in 101 samples"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 false negatives in 299 samples"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.3","unit":"%","info":"95% CI: 96.4% - 99.2%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.1","unit":"%","info":"95% CI: 86.4% - 96.6%"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI: 98.7% - 100%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1783","commercial_name":"Rapid SARS-CoV-2 Antigen Test (nasopharyngeal\/nasal specimen)","manufacturer":{"id_manufacturer":"1107","name":"InTec Products Inc.","country":"China","website":"http:\/\/www.intecasi.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":["Chlamydia Pneumoniae","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","MERS-CoV","Human Metapneumovirus (HMPV)","Influenza A H1N1","Influenza A H3N2","Influenza B Yamagata","Mycobacterium Tuberculosis","Mycoplasma Pneumoniae","Parainfluenza Virus Type 1","Respiratory Syncytial V (RSV) Type A","SARS-CoV"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"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":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Intended use The Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal\/nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. The test is suitable for use under healthcare professional supervision. Individuals should have appropriate training in how to administer the test correctly.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1462","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"425","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.4","unit":"%","info":"2 in 1026 cases"},{"parameter":"False negatives","value":"4.5","unit":"%","info":"20 in 484 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%","info":"95%CI: 97.8%~99.0%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.5","unit":"%","info":"95%CI: 93.7%~97.3%"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":"95%CI: 99.3%~99.9%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1988","commercial_name":"Biozek covid-19 Antigen Rapidtest BCOV-502","manufacturer":{"id_manufacturer":"910","name":"Inzek International trading","country":"Netherlands","website":"www.biozek.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"Changes in the IFU and additional information about variants detection. We have received the following message from the DHSC (Department of Health and social care): product progressed through phase 3A validation and has been examined at a Design Authority Review (DAR). We would like to advise you that the Biozek COVID-19 Antigen Rapid Test Cassette (Swab) was successful in the phase 3A validation and that the Biozek COVID-19 Antigen Rapid Test Cassette (Swab) showed no drop off in sensitivity when compared with the wild type with respect to the following variants - Alpha (VOC1 Kent, UK, B.1.1.7), Beta (VOC2 South Africa, B.1.351), Gamma (VOC3 Brazil, P1) and Delta (VOC4 India B.1.617.2).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1664","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.65","unit":"%","info":"4\/151"},{"parameter":"False negatives","value":"0.67","unit":"%","info":"10\/1484"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.14","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.63","unit":"%"},{"parameter":"Clinical Specificity","value":"99.73","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1987","commercial_name":"Biozek covid-19 Antigen Rapidtest BCOV-802","manufacturer":{"id_manufacturer":"910","name":"Inzek International trading","country":"Netherlands","website":"www.biozek.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"Check IFU for more information. Clinical studies available. Biozek Sales organisation Mach-E BV the Netherlands","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1663","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.28","unit":"%","info":"(1 \/ 354)"},{"parameter":"False negatives","value":"8.33","unit":"%","info":"(12 \/ 144)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"nucleocapsid protein "}]}]},{"id_device":"2138","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold )","manufacturer":{"id_manufacturer":"989","name":"ISO13485","country":"China","website":"https:\/\/www.lsybt.com\/En\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"In vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in swab specimen within the first 5-7 days after onset of COVID-19 symptoms","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1828","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"400","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"(\u22641%)"},{"parameter":"False negatives","value":"5","unit":"%","info":"(\u226595%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.68","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.14","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2217","commercial_name":"PixoTest\u00ae POCT COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"1031","name":"iXensor","country":"Taiwan ROC","website":"https:\/\/www.ixensor.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC","Semi-automated"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab","Nasopharyngeal swab"],"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":"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":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"PixoTest POCT Antigen Testing solution is an analyzer based rapid antigen test designed for point-of-care. It provides an end-to-end fully digitalized solution from rapid antigen test, timely result with digital pass issuing and access control by cross-validating test results on the cloud through a suite of digital tools including PixoHealth Pass App, PixoHealth Pass Admin App and Web portal for enterprises to prevent potential outbreaks.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1918","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"125","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"5","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":" (Antigen) Taipei"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"5754","commercial_name":"SARS-COV-2 Antigen Rapid Test Kit","manufacturer":{"id_manufacturer":"3208","name":"Jiangsu Baozhilin Medical Co Ltd","country":"China","website":""},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"last_updated":"2022-11-07 14:09:56 CET","testList":[{"id_test":"5287","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"samples"},{"parameter":"False negatives","value":"2","unit":"samples"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"99.61","unit":"%"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98.2","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"2821","commercial_name":"SARS-COV-2 Antigen Rapid Test Kit ","manufacturer":{"id_manufacturer":"1260","name":"Jiangsu Baozhilin Medical Technology Co. Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Fully automated (robot)","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Throat secretion","Throat swab"],"pathogen":[],"lineage":[{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":[],"notes":"Novel Coronavirus antigen rapid detection reagent is an effective early screening and diagnostic index of novel Coronavirus infection, which is an effective complement to the false positive of COVID-19 nucleic acid test. Rapid detection within 15 minutes with a nasopharyngeal test paper, the reagents can be stored at room temperature and transported, which is a great boon to the medical community.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2526","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"Analytical Sensitivity","value":"91","unit":"%"},{"parameter":"Analytical Specificity","value":"97","unit":"%"}]}]},{"id_device":"2833","commercial_name":"SARS-CoV-2 IgG\/IgM rapid test kits\uff08Golloidal Gold)","manufacturer":{"id_manufacturer":"1260","name":"Jiangsu Baozhilin Medical Technology Co. 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Medomics SARS-CoV-2 antigen Test Kit(LFIA) detects the SARS-CoV-2 nucleocapsid antigens with colloidal gold immunochromatography using a double antibody sandwich assay.","last_updated":"2022-10-12 17:48:07 CET","testList":[{"id_test":"3969","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"10","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"9.64","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.9","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"90.36","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2982","commercial_name":"SARS-CoV-2 Antigen Test Kit (LFIA) Self-testing","manufacturer":{"id_manufacturer":"903","name":"Jiangsu Medomics medical technology Co. 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The test kit is designed for use as self-testing. This test kit is intended use for individuals by 18 or older with clinical symptoms of SARS-CoV-2 infection or who are suspected of COVID-19. 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The test is intended for detection of neutralization antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in whole blood, serum or plasma specimen from the population vaccinated with SARS-CoV-2 vaccine.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2042","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.69","unit":"%"},{"parameter":"False negatives","value":"0.87","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.31","unit":"%"},{"parameter":"Clinical Specificity","value":"99.13","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2339","commercial_name":"SARS-CoV-2 Total Antibody Rapid Test Kit","manufacturer":{"id_manufacturer":"1083","name":"Jiangsu Mole Bioscience Co. Ltd.","country":"China","website":"http:\/\/en.molechina.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Plasma","Serum","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[],"target":[],"notes":"SARS-CoV-2 Total Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of total antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2040","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"10","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6.31","unit":"%"},{"parameter":"False negatives","value":"1.06","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.69","unit":"%"},{"parameter":"Clinical Specificity","value":"98.94","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2144","commercial_name":"COVID-19 Ag Rapid Test Device","manufacturer":{"id_manufacturer":"992","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":null},"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":[{"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"}],"target":["nucleocapsid protein"],"notes":"COVID-19 Ag Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of N antigen to SARS-CoV- 2 present in human nasal swabs. This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient. The result of this test should not be the sole basis for the diagnosis; con\ufb01rmatory testing is required.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1834","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5.26","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.74","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2500","commercial_name":"Orawell COVID-19 Ag Rapid Saliva Test Device (CO-03)","manufacturer":{"id_manufacturer":"1139","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"www.wellbioscience.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":["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"}],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2204","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"60","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False negatives","value":"4.4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.21","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2517","commercial_name":"Orawell COVID-19 Ag Rapid Saliva Test Device (CO-07)","manufacturer":{"id_manufacturer":"1139","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"www.wellbioscience.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":["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"}],"target":[],"notes":"NA","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2221","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"60","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False negatives","value":"3.8","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.48","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.15","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2495","commercial_name":"OraWell COVID-19 Ag.Rapid Saliva test DEVICE, CO-07(One Step)","manufacturer":{"id_manufacturer":"1131","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"https:\/\/www.wellbioscience.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC","Other","Semi-automated"],"target_type":["Antigen"],"specimen":["Other","Saliva","Sputum"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Principle The COVID-19 Ag Rapid Saliva Test Device uses double antibody sandwich immunoassay. The NC membrane pre-immobilized with monoclonal antibodies against SARS-CoV-2 antigen and anti-mouse polyclonal antibodies, and the colloidal-gold conjugated with monoclonal antibodies specific to SARS-CoV-2 antigen. If SARS-CoV-2 antigen present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the antigen will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 to 20 minutes in the form of a red line that develops on the strip. Whether the sample contains the SARS-CoV-2 antigen or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C. Kit Content 1) Test device (individually packed in a foil pouch with desiccant). 2) Instruction for use. Materials required but not provided Timer Precautions \u2022 For in vitro diagnostic use only. \u2022 Do not re-use the test device. \u2022 Do not use after the expiration date. \u2022 Do not use the test kit if the pouch is damaged or the seal is broken. \u2022 Perform test at room temperature 15 to 30\u00b0C. \u2022Wear gloves when hanging the samples, avoid touching the reagent membrane and sample window. \u2022 All samples and used accessories should be treated as infectious and discarded according to local regulations. \u2022 Avoid using blood samples.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2198","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":"25","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.65","unit":"%","info":"6 on 129"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 on 200"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.21","unit":"%","info":"98,21 %"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2496","commercial_name":"OraWell COVID-19 NEUTRALIZING ANTIBODY Rapid Test Device - CO_04 (Check vaccination coverage)","manufacturer":{"id_manufacturer":"1131","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"https:\/\/www.wellbioscience.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC","Other","Semi-automated"],"target_type":["Antibody","IgG"],"specimen":["Peripheral blood","Plasma","Serum","Whole blood"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""}],"target":[],"notes":"COVID-19 neutralizing antibody Test is a chromatographic immunoassay for the detection of neutralizing antibodies to COVID-19 in human whole blood, serum and plasma. The test device contains: 1) Colloidal gold-labeled recombinant SARS-CoV-2 RBD antigen; 2) Detection line (T line) immobilized with SARS-CoV-2 RBD antigen for detecting COVID-19 neutralizing antibody and Control line(C line) immobilized with quality contro! antibody on nitrocellulose membrane. Ifthe sample contains COVID-19 neutralizing antibody, it will bind to antigens coated on colloidal gold, and a pink colored band will develop in the test region (T) on the membrane.If there is no COVID-19 neutralizing antibody in the sample, the pink colored band in the test region (T) will not appears and that suggests a negative result.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2199","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.6","unit":"%","info":"7 on 152"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 on 371"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.65","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.39","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2490","commercial_name":"Saliva Orawell Covid_19 Ag","manufacturer":{"id_manufacturer":"1131","name":"Jiangsu Well Biotech Co. Ltd.","country":"China","website":"https:\/\/www.wellbioscience.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC","Semi-automated"],"target_type":["Antigen"],"specimen":["Other","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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Il test \u00e8 costruito a ciclo chiuso antiadulterante del prelievo, con flacone reagente predisposto all'inserimento del tamponcino_prelievo e utilizzabile come contagocce( senza trasferimento o travasi del prelievo)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2193","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Rapid test Device- CO-03 . registrato come DM n. 2015988\/r al Portale DM del Ministero della Salute","performances":[{"parameter":"LOD","value":"25","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.85","unit":"%","info":"1 su 35"},{"parameter":"False negatives","value":"0","unit":"%","info":"0 su 200"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.57","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"4099","commercial_name":"SARS-CoV-2 Antigen Rapid Test (Self-Testing) (Nasal)","manufacturer":{"id_manufacturer":"1466","name":"JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO. LTD.","country":"China","website":""},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":["SARS-CoV","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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"last_updated":"2022-09-29 09:02:26 CET","testList":[{"id_test":"3887","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"500","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"93.55","unit":"%"},{"parameter":"Analytical Specificity","value":"99.9","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"strips"},{"parameter":"False negatives","value":"8","unit":"strips"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.61","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.55","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"}]}]},{"id_device":"2963","commercial_name":"DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit","manufacturer":{"id_manufacturer":"3182","name":"Jiangxi Province JinHuan Medical Instrument Co. Ltd.","country":"China","website":"http:\/\/www.jinhuan123.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":"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":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The device is commercialised in Germany and listed at the BfArM under the test-ID \"AT770\/21\". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770\/21 (March 2022).","last_updated":"2022-10-20 10:13:42 CET","testList":[{"id_test":"5221","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.34","unit":"%","info":"Nasal swab"},{"parameter":"False negatives","value":"4","unit":"%","info":"Nasal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.56","unit":"%","info":"Saliva"},{"parameter":"Accuracy","value":"99.07","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Accuracy","value":"98.7","unit":"%","info":"Nasal swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Sensitivity","value":"97.62","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Clinical Sensitivity","value":"92.16","unit":"%","info":"Saliva"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99.64","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Clinical Specificity","value":"98.62","unit":"%","info":"Saliva"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3004","commercial_name":"MEDSYS Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit","manufacturer":{"id_manufacturer":"3227","name":"Jiangxi Province JinHuan Medical Instrument Co. Ltd.","country":"China","website":"http:\/\/www.jinhuan123.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":"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":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Twin product to \"DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit\" (EU-ID: 2963), packaged under MEDSYS label. \r\n\r\nThe device is commercialised in Germany and listed at the BfArM under the test-ID \"AT770\/21\". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770\/21 (March 2022).","last_updated":"2022-12-12 16:50:20 CET","testList":[{"id_test":"5377","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.34","unit":"%","info":"Nasal swab"},{"parameter":"False negatives","value":"4","unit":"%","info":"Nasal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.56","unit":"%","info":"Saliva"},{"parameter":"Accuracy","value":"99.07","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Accuracy","value":"98.74","unit":"%","info":"Nasal swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Sensitivity","value":"97.62","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Clinical Sensitivity","value":"92.16","unit":"%","info":"Saliva"},{"parameter":"Clinical Specificity","value":"99.66","unit":"%","info":"Nasal swab"},{"parameter":"Clinical Specificity","value":"99.64","unit":"%","info":"Naso-\/oropharyngeal swab (pooled)"},{"parameter":"Clinical Specificity","value":"98.62","unit":"%","info":"Saliva"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3085","commercial_name":"Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit","manufacturer":{"id_manufacturer":"1308","name":"Jiangxi Province JinHuan Medical Instrument Co. Ltd. China","country":"China","website":"http:\/\/www.jinhuan123.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","Nasopharyngeal swab","Oropharyngeal swab","Saliva"],"pathogen":["SARS-CoV"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The device is commercialised in Germany and listed at the BfArM under the test-ID \"AT770\/21\". The device and current submission have been updated to include nasopharyngeal, oropharyngeal and saliva swab in addition to the nasal swab, the update has been approved by BfArM under the same national test-ID AT770\/21 (March 2022). The analytical components of the test are same as the EU device 2963 (https:\/\/covid-19-diagnostics.jrc.ec.europa.eu\/devices\/detail\/2963). However, it has new instructions of use along with new specimen collection methods and respective clinical data.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2791","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Clone1 binding site: INTNSSP(74-80) Clone2 binding site: GTRNPANN(147-154)","performances":[{"parameter":"LOD","value":"1","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.34","unit":"%","info":"False positive occurs 1 in 297 cases"},{"parameter":"False negatives","value":"4","unit":"%","info":"False negative occurs 4 in 100 cases"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.7","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1777","commercial_name":"SARS-COV-2\/Influenza A&B Rapid Antigen Test","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":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1456","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"U\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.1","unit":"%"}]}]},{"id_device":"2813","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit-PRO (Colloidal Gold)","manufacturer":{"id_manufacturer":"1258","name":"JOYSBIO (Tianjin) Biotechnology Co. Ltd.","country":"China","website":"https:\/\/en.joysbio.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":[{"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"this test is evaluated by PEI in Germany and marked as passed evaluation. It is listed as \"Joysbio SARS-CoV-2 Antigen rapid test kit - PRO (Colloidal Gold)\" in the PEI evaluation list. ","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2518","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"120","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.44","unit":"%","info":"1 out of 224 RT-PCR negative specimens"},{"parameter":"False negatives","value":"1.81","unit":"%","info":"2 out of 110 RT-PCR positive specimens"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.1","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.18","unit":"%"},{"parameter":"Clinical Specificity","value":"99.55","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2038","commercial_name":"COVID-19 Antigen Rapid Test Kit","manufacturer":{"id_manufacturer":"939","name":"Koch Biotechnology (Beijing) Co. Ltd.","country":"China","website":"www.kochbiotech.net"},"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":"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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The KOCH Biotechnology COVID-19 Antigen Rapid Test Kit is an in-vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal- (Nasopharynx) or oropharyngeal- (throat) swab specimens from individuals who meet COVID-19 clinical and \/ or epidemiological criteria. The KOCH COVID-19 Antigen Rapid Test Kit is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don\u2019t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a blood donor screening test for SARS-CoV-2. The KOCH Biotechnology COVID-19 Antigen Rapid Test Kit is based on colloidal gold immunochromatography to detect nucleocapsid (N) of the SARS-CoV-2 virus in respiratory secretions. When the specimen is added into the solution buffer inside the virus preservation tube and the test stripe has been added, the specimen is absorbed by the test stripe by capillary action, mixes with the gold-labelled antibody and flows across the pre-coated membrane. The antigen in the sample is captured by the gold-labelled antibody N1a and then bound to the antibody N1 immobilized in the test region (T) of the membrane. This creates a coloured line and indicates a positive test result. If there is no COVID-19 antigen in the specimen or the concentration is lower than the detection limit of the test, there is not a visible coloured line in the Test Region (T) of the device. This indicates a negative result. To serve as a procedure control, a coloured line will appear at the Control Region (C), if the test has been performed properly","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3674","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"115"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%"},{"parameter":"False negatives","value":"0.7","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%","info":"(95%CI*: 98,30-99,70%)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98.5","unit":"%","info":"(95%CI*: 97,20-99,80%)"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%","info":"(95%CI*: 98,50-100%)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2786","commercial_name":"Laboquick COVID 19 Ag Rapid Test Kit","manufacturer":{"id_manufacturer":"1251","name":"Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat San. Ve Tic Ltd. Sti.","country":"Turkey","website":"http:\/\/www.koroglugroup.com"},"ce_marking":"Yes","commercial_status":null,"hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Throat swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Laboquick COVID 19 Rapid Test Kit Koroglu Medical Devices - English Koroglu Medikal T\u0131bbi Malzemeleri Kozmetik Ithalat Ihracat San. Ve Tic. Ltd. Sti. - Turkish 1776\/23 Sok. No:4\/A Mevlana Mah. Bornova - Izmir 35050 - Turkey Tel:+90 232 388 73 74 Fax:+90 232 388 40 43 e-mail: info@koroglugroup.com","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2491","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"250","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.6","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.8","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3936","commercial_name":"SARS-CoV-2 Antigen  Influenza A B Rapid Test Kit(Immunochromatography)","manufacturer":{"id_manufacturer":"1441","name":"Labnovation Technologies Inc.","country":"China","website":"www.labnovation.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["Adenovirus","Adenovirus 3","Adenovirus 7","Adenovirus Subtype B","Adenovirus Subtype C","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Anti-Nuclear Antibody","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Bordetella Pertussis","Chlamydia Pneumoniae","Coronaviruses (HCoV)","Cytomegalovirus (CMV)","Enterovirus A71 (EV-A71)","Epstein-Barr Virus (EBV)","Hemophilus Influenzae","Hepatitis A Virus (HAV)","Hepatitis B Virus (HBV)","Hepatitis C Virus (HCV)","Herpes Simplex (HSV)","Human Immunodeficiency Virus (HIV)","Human Metapneumovirus (HMPV)","Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza A H5N1","Influenza B","Influenza B Victoria","Influenza B Yamagata","MERS-CoV","Mumps Virus (MuV)","Mycobacterium Tuberculosis","Mycoplasma Pneumoniae","Parainfluenza Virus Type","Parainfluenza Virus Type 1","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Parainfluenza Virus Type 4","Respiratory Syncytial V (RSV)","Respiratory Syncytial V (RSV) Type A","Respiratory Syncytial V (RSV) Type B","Rhinovirus","Rhinovirus A","Rhinovirus B","SARS-CoV","Varicella Zoster Virus (VZV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["angiotensin-converting enzyme 2","envelope protein","membrane protein","non-structural protein NS10","non-structural protein NS3a","non-structural protein NS3b","non-structural protein NS6","non-structural protein NS7a","non-structural protein NS9a","non-structural protein Ns9b","non-structural protein NSP1","non-structural protein NSP10","non-structural protein NSP12","non-structural protein NSP13","non-structural protein NSP14","non-structural protein NSP15","non-structural protein NSP16","non-structural protein NSP2","non-structural protein NSP3","non-structural protein NSP4","non-structural protein NSP5","non-structural protein NSP6","non-structural protein NSP7","non-structural protein NSP8","non-structural protein NSP9","Nonstructural protein NS7b","nucleocapsid protein","ORF1a polyprotein","ORF1ab polyprotein","ORF1b polyprotein","spike protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3602","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"30","unit":"TCID50\/ml"},{"parameter":"Analytical Sensitivity","value":"95.15","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"False positives","value":"0","unit":"tests"},{"parameter":"False negatives","value":"8","unit":"tests"},{"parameter":"Accuracy","value":"98.7","unit":"%"},{"parameter":"Clinical Sensitivity","value":"95.15","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1266","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)","manufacturer":{"id_manufacturer":"346","name":"Labnovation Technologies Inc.","country":"China","website":"www.labnovation.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"],"pathogen":["SARS-CoV-2"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"We need to update the commercial name of the device reported in the common list to make sure it's same with our CE certificate. \r\nThe correct commercial name of the device is SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography).","last_updated":"2022-12-05 09:30:59 CET","testList":[{"id_test":"5356","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"8","unit":"AU"},{"parameter":"False 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swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3632","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"850","unit":"TCID50\/ml"},{"parameter":"Analytical Sensitivity","value":"80","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"3","unit":"%"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Clinical Sensitivity","value":"80","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"3010","commercial_name":"Pekit Covid-19 Rapid (H\u0131zl\u0131) Antigen Test","manufacturer":{"id_manufacturer":"1335","name":"Labormed T\u00c4\u00b1bbi \u00c3\u0153r\u00c3\u00bcnler San Ve Tic Ltd. \u00c5\u017eT\u00c4\u00b0","country":"Turkey","website":"www.labormed.biz"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Throat swab"],"pathogen":["Coronaviruses (HCoV)","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","SARS-CoV"],"lineage":[],"target":["nucleocapsid protein"],"notes":"www.labormed.biz","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2716","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":"Multiple","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"580","unit":"TCID50\/ml"},{"parameter":"Positive control","value":"1.66","unit":"%","info":"100xTP\/(TP+FP)=100x238\/242=98.34%"},{"parameter":"Negative control","value":"1.49","unit":"%","info":"100xTN\/(FN+TN)=100x530\/538=98.51%"},{"parameter":"Analytical Sensitivity","value":"93.76","unit":"%"},{"parameter":"Analytical Specificity","value":"97.5","unit":"%"},{"parameter":"Clinical Sensitivity","value":"96.89","unit":"%"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%"}]}]},{"id_device":"3092","commercial_name":"COVID-19 Antigen Test Kit (Colloidal gold immunochromatographic assay)","manufacturer":{"id_manufacturer":"1372","name":"Langfang Xinruikang Biotechnology Co. Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"performances Alpha(98;96);Beta(97;94);Gamma(98;95);Delta(98;96);Omicr on(97;96)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2798","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"25","info":"pg\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"All diagnostic tests may be subject to false positive results, especially in low prevalence settings"},{"parameter":"False negatives","info":"Improper sample collection, transport and handling, and low virus concentrations in samples can le"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"89","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"97","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3151","commercial_name":"LEPZI Qualitative COVID-19 Test","manufacturer":{"id_manufacturer":"162","name":"Lifeassay Diagnostics Pty Ltd.","country":"United States","website":"lifesadx.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"The LEPZI\u2122 COVID-19 Antigen Detection Kit (or Test) is a lateral flow immunoassay for qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in nasal swab and throat swab specimens. This test is intended for individuals who are suspected of COVID-19 infection by their healthcare provider during the first five days from onset of symptoms.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2859","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","notes":"antigen_epi In the presence of SARS-CoV-2, nucleocapsid protein antigens from the virus bind to antibodies conjugated to colloidal gold particles. The antigen-conjugate complexes migrate by capillary action along the lateral flow strip inside the test cassette and bind to a capture antibody.","performances":[{"parameter":"LOD","value":"250","unit":"PFU\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","info":"1\/20"},{"parameter":"False negatives","value":"0","info":"0\/20"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%","info":"Higher than 95% - Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90","unit":"%","info":"Higher than 90% - Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2866","commercial_name":"COVID-19 Antigen Test Cassette","manufacturer":{"id_manufacturer":"1273","name":"Lifecosm Biotech Limited","country":"China","website":"Lifecosm Biotech Limited, China"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"Sensitivity, specificity and accuracy are from the newest performance evaluation - including false-positives and false-negatives. German Paul-Ehrlich-Institut (PEI) evaluated this test under the test-id AT 1054\/21. Old performance evaluation: Sensitivity 92,20%, specificity 98,10%, accuracy 96,20%.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2571","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","info":"pg\/ml for recombine COVID-19 protein"},{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for virus"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"None"},{"parameter":"False negatives","value":"6","unit":"%","info":"None"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1867","commercial_name":"Cromatest COVID-19 Antigen Cassette","manufacturer":{"id_manufacturer":"857","name":"LINEAR CHEMICALS S.L.U.","country":"Spain","website":"www.linear.es"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":["Microplate"],"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"N\/A","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1544","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"280","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"7.7","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.3","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"678","commercial_name":"COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay)","manufacturer":{"id_manufacturer":"166","name":"LOMINA AG","country":"Switzerland","website":"www.lomina.ch\/"},"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":["Oropharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"807","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Fluorescence","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"ng\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Accuracy","value":"96.63","unit":"%"},{"parameter":"Clinical Sensitivity","value":"94.55","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"SARS-CoV-2 Nucleocapsid Protein Antigen"}]}]},{"id_device":"3678","commercial_name":"Lomina SARS-CoV-2 Antigen LTX Selftest","manufacturer":{"id_manufacturer":"1430","name":"Lomina Sperbio a.s.","country":"Czechia","website":"lomina.ch"},"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":["SARS-CoV"],"lineage":[{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3365","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Other","subcategory":null,"time_minutes":"15","performances":[{"parameter":"False positives","value":"0.47","unit":"%"},{"parameter":"False 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CET","testList":[{"id_test":"3832","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Immunofluorescence","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"300000","unit":"TCID50\/ml","info":"3x10^5"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.47","unit":"%"},{"parameter":"False negatives","value":"1.26","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.04","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"}]}]},{"id_device":"2560","commercial_name":"Lomina SARS-CoV-2 Antigen LTX test","manufacturer":{"id_manufacturer":"1002","name":"Lomina Superbio a.s.","country":"Czechia","website":"www.lomina.ch"},"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":["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":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"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":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human nasal swab samples in vitro. It is used as a supplementary detection indicator for suspected cases of new coronavirus.","last_updated":"2022-12-07 08:49:13 CET","testList":[{"id_test":"20272","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":"15","performances":[{"parameter":"LOD","value":"30000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%","info":"Of the 320 negativve samples, 0 were false positive"},{"parameter":"False negatives","value":"2.3","unit":"%","info":"Of the 130 positive samples, 3 were false negative"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.33","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.7","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%","info":">99.9%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2765","commercial_name":"Lomina SARS-CoV-2 Antigen LTX test (saliva)","manufacturer":{"id_manufacturer":"1002","name":"Lomina Superbio a.s.","country":"Czechia","website":"www.lomina.ch"},"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":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"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":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human saliva samples in vitro. It is used as a supplementary detection indicator for suspected cases of new coronavirus. It cannot be used as the only basis for the diagnosis and exclusion of pneumonitis infected by new coronavirus.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2470","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":"15","performances":[{"parameter":"LOD","value":"230","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Of the 103 positive samples, 0 were false positive"},{"parameter":"False negatives","value":"204","unit":"%","info":"Of the 250 negative samples, 6 were false negative"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.17","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2158","commercial_name":"LOMINA SARS-CoV-2 N-Protein Antigen Rapid Test","manufacturer":{"id_manufacturer":"1002","name":"Lomina Superbio a.s.","country":"Czechia","website":"www.lomina.ch"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC","Semi-automated"],"target_type":["Antigen"],"specimen":["Oropharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The test kit is intended for the qualitative detection of the new Nucleocapsid (N) antigen of the coronavirus SARS-CoV-2 in human oropharyngeal swab samples in vitro. It is used as an additional early detection indicator for suspected cases of nucleic acid detection, or is used in conjunction with the detection of nucleic acid in the diagnosis of suspected cases of COVID19. It cannot be used as a main test to diagnose and rule out pneumonitis caused by a new coronavirus. Limit of detection (LOD): 20 TCID 50ml\/(CT>38)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1859","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"20","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"%"},{"parameter":"False negatives","value":"2","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of 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CET","testList":[{"id_test":"3962","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":"15","performances":[{"parameter":"LOD","value":"30000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.47","unit":"%"},{"parameter":"False negatives","value":"1.26","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.04","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"}]}]},{"id_device":"2094","commercial_name":"COVID19AgLTFLOW","manufacturer":{"id_manufacturer":"970","name":"LT Biotech JSC","country":"Lithuania","website":"www.ltbiotech.lt"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"Additional validation is performed in third party laboratory in 2021-12-03","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1777","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Enzyme-linked","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"\u00b5g"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"20","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.12","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.01","unit":"%"},{"parameter":"Clinical Specificity","value":"99.52","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2654","commercial_name":"LUCA NK COVID-19 Ag LLB","manufacturer":{"id_manufacturer":"1214","name":"LUCA AICELL Inc.","country":"South Korea","website":"http:\/\/lucaaicell.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","Nasopharyngeal swab"],"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":["nucleocapsid protein"],"notes":"Regarding your question on the swabs, there is no distinction between nasal and nasopharyngeal. Our swabs can be used for both nasal and nasopharyngeal. Therefore, we have included only 25 swabs. Does this clarify your question?","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2359","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":"10","performances":[{"parameter":"LOD","value":"2","unit":"ng\/mL","info":"Nucleocapsid protein recombinant antigen"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"3","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2668","commercial_name":"LUCA NK COVID-19 Ag Nasal LLB","manufacturer":{"id_manufacturer":"1214","name":"LUCA AICELL Inc.","country":"South Korea","website":"http:\/\/lucaaicell.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":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"}],"target":["nucleocapsid protein"],"notes":"Registration Number (at the German CA\/DIMDI)DE\/CA70\/40838 : 166347","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2373","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":"10","performances":[{"parameter":"LOD","value":"2","unit":"ng\/mL","info":"(Nucleocapcid protein recombinant antigen"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"3","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2670","commercial_name":"LUCA NK COVID-19 Ag NP LLB","manufacturer":{"id_manufacturer":"1214","name":"LUCA AICELL Inc.","country":"South Korea","website":"http:\/\/lucaaicell.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":["Nasopharyngeal swab"],"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":["nucleocapsid protein"],"notes":"Registration Number(at the German CA\/DIMDI)DE\/CA70\/40838 : 166347","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2375","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":"10","performances":[{"parameter":"LOD","value":"2","unit":"ng\/mL","info":"Nucleocapcid protein recombinant antigen"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"3","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2669","commercial_name":"LUCA NK COVID-19 Ag Saliva LLB","manufacturer":{"id_manufacturer":"1214","name":"LUCA AICELL Inc.","country":"South Korea","website":"http:\/\/lucaaicell.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":["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"}],"target":["nucleocapsid protein"],"notes":"Registration Number(at the German CA\/DIMDI)DE\/CA70\/40838 : 166347","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2374","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":"10","performances":[{"parameter":"LOD","value":"2","unit":"ng\/mL","info":"Nucleocapcid protein recombinant antigen"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"3","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2128","commercial_name":"PocRoc\u00aeSARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"986","name":"Lumigenex (Suzhou) Co. Ltd.","country":"China","website":"http:\/\/www.lumigenex.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"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":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"}],"target":[],"notes":"The product PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) was registered in Spain on 1st, Nov, 2020. We have sold millions of this product on the German market. Until now, there is no negative feedback from the market. After being listed by BfArM with AT455\/20, the PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) has positive results by PEI on Mar. 15,2021.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1818","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"121","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.84","unit":"%"},{"parameter":"False negatives","value":"6.67","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.38","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.33","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99.16","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2928","commercial_name":"RAPICHECK COVID-19 Ag","manufacturer":{"id_manufacturer":"1290","name":"M.I.Tech Co. Ltd.","country":"South Korea","website":"www.mitech.co.kr"},"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":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"Expiration date : 18 months","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2634","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"15.6","unit":"PFU\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4","unit":"AU"},{"parameter":"False negatives","value":"1","unit":"AU"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1918","commercial_name":"Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM\/IgG Antibody Assay Kit by Colloidal Gold Method","manufacturer":{"id_manufacturer":"168","name":"Maccura Biotechnology Co. 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Eon Biotechnology controls biotechnology assets which include clones for SARS-CoV2 antigens & antibodies, vaccine platforms, ScFv libraries for SARS-CoV-2 antibodies and the derived immunodiagnostic & therapeutic products with a specific purpose of translation & commercialization across the world. This platform technology is leveraged for COVID-19 currently and eventually to other emerging infectious diseases and lifestyle disease conditions. Eon operates a compliant biotherapeutic infrastructure with governing structure for \u2018Genetic Engineering Approval Committee\u2019, Animal Ethics Committee, and Institutional Ethics committee and product approvals from an R&D perspective. CE certificate in Europe, EN ISO 13485, ISO 9001, WHO \u2013 GMP and other requisite infrastructure compliances form the quality support system behind products of Eon Biotechnology. Eon Biotechnology\u2019s offerings are backed by: 1. Technology refined by experience in deep research. 2. Physical infrastructure - associated hospitals that attend to COVID-19 positive subjects every day & therefore a constant real time opportunity to monitor & test improved versions of the test. 3. Physical manufacturing infrastructure capable of producing large volumes of tests. 4. EONbtTM COVID-19 Rapid Antigen test is a quality driven product backed by comprehensive real time know-how and infrastructure. Background of SARS-COV-2: SARS-CoV-2 is a novel, zoonotic coronavirus that emerged in late 2019 in patients with pneumonia of unknown cause. The virus was named SARS-CoV-2 because of its similarity to the coronavirus responsible for severe acute respiratory syndrome (SARS-CoV, a lineage B betacoronavirus). SARS-CoV-2 is an enveloped, positive sense, single stranded RNA virus sharing more than 70% of its sequence with SARS-CoV, and ~50% with the coronavirus responsible for Middle Eastern respiratory syndrome (MERS-CoV).The SARS-CoV-2 spike glycoprotein (S), which is a main target for neutralizing antibody, binds to its receptor human angiotensin converting enzyme 2 (hACE2) to initiate infection.SARS-CoV-2 is the cause of COVID-19, an infectious disease with respiratory and systemic manifestations. Disease symptoms vary, with many persons presenting with asymptomatic or mild disease and some progressing to severe respiratory tract disease including pneumonia and acute respiratory distress syndrome (ARDS), leading to multi organ failure and death. Corona virus can be extracted through respiratory secretions or transmitted through oral fluid, sneezing, physical contact, and other air droplets. There are 2 main proteins involved and necessary for the infection of humans by coronavirus. These are: 1. Spike protein (which is a trimeric protein containing 3 different sub-units, among three subunits subunit S2 is highly conserved and subunit S1 is essential to make an entry into the host cell). 2. Nucleocapsid protein which is essential for viral assembly. 3. These 2 proteins play an important role in the infection and viral life cycle in human beings. They are the potential target molecules in the development of rapid tests for detection of coronavirus infection in humans. EXECUTIVE SUMMARY: EONbtTM COVID-19 ANTIGEN-SALIVA is marketed by EON BIOTECHNOLOGY LTD., U.K and manufactured by Angstrom Biotech Private Limited is intended for Point of Care (POC) diagnosis of coronavirus infection. The product is CE approved in Europe. COVID-19 ANTIGEN-SALIVA is a lateral flow immunoassay intended for in vitro qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in saliva specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset. This test is designed for Point of Care use, as an aid to early diagnosis of SARS-CoV-2 infection in patients with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. The administration of the test and the interpretation of the results should be done by a trained health professional. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required. EONbtTM COVID-19 ANTIGEN-SALIVA is an antigen-capture immunochromatographic assay, detecting presence of COVID-19 viral nucleoprotein antigen in saliva samples. The detection kit uses the principle of immunochromatography: separation of components in a mixture through a medium using capillary force and the specific and rapid binding of an antibody to its antigen. Why Saliva? Infrastructure Benefits: Nasopharyngeal and oropharyngeal swabs are inconvenient to collect and pose a transmission risk to healthcare workers due to coughing induced during the collection process. The Saliva sampling method will allow for broader population screening than the current method of nose and throat swabs. It allows people of any ability to be tested for SARS-COV-2. The impact of using Saliva samples is significant. It means health care professionals are not at risk of contracting the COVID-19 infection by administering Saliva tests when compared with performing nasopharyngeal or oropharyngeal collections. The saliva sample method preserves precious personal protective equipment (PPE) for use in vital patient care in hospitals instead of testing. The number of people tested every day can be significantly increased as sampling of saliva is quicker and more scalable than swab collections. All of this combined will have an immediate impact on testing capability across the United States.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1862","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"4","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.7","unit":"%","info":" (In trial of 428 negative samples compared with RTqPCR test ,3 False Positives were detected)"},{"parameter":"False negatives","value":"8.05","unit":"%","info":" (In trial of 149 positive samples compared with RTqPCR test, 12 False negatives were detected)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.04","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.95","unit":"%"},{"parameter":"Clinical Specificity","value":"99.27","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1190","commercial_name":"m\u00f6-screen Corona Antigen Test","manufacturer":{"id_manufacturer":"532","name":"m\u00c3\u00b6Lab","country":"Germany","website":"www.moelab.de\/startseite.html"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"Yes","hsc_mutual_recognition":"Yes","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Throat swab"],"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":"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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Omicron will be detected","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"974","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","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.42","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%"},{"parameter":"Clinical Specificity","value":"99.99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2162","commercial_name":"Wellion SARS-CoV-2 PLUS ANTIGEN Rapid Test","manufacturer":{"id_manufacturer":"1005","name":"MED TRUST Handelsges.m.b.H.","country":"Austria","website":"www.wellion.at"},"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","Nasopharyngeal swab","Oropharyngeal swab"],"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":"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":""}],"target":["nucleocapsid protein"],"notes":"Clinical evaluation study from Germany is available and uploaded to the database.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1863","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":"15","performances":[{"parameter":"LOD","value":"75.5","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"(431 negative samples were tested and 0 of them were false positive)"},{"parameter":"False negatives","value":"3","unit":"%","info":"(135 positive samples were tested and 5 of them were false negative)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%","info":" (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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Ltd.","country":"China","website":"www.medcaptain.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","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"N\/A","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1391","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%"},{"parameter":"False negatives","value":"1.35","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94.7","unit":"%","info":"Antigen"},{"parameter":"Accuracy","value":"98.87","unit":"%"},{"parameter":"Accuracy","info":"98.85%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.65","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2050","commercial_name":"Coronavirus Disease 2019 Antibody (IgM\/IgG) Combined Test Kit","manufacturer":{"id_manufacturer":"944","name":"MedicalSystem Biotechnology Co. Ltd.","country":"China","website":"https:\/\/en.nbmedicalsystem.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based"],"target_type":["Antibody","IgG","IgM"],"specimen":["Other biological fluids","Peripheral blood","Plasma","Saliva","Serum","Sputum","Stool","Throat secretion","Throat swab","Tissue homogenates","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""}],"target":[],"notes":"N.A.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1728","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"180","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"8.23","unit":"%"},{"parameter":"False negatives","value":"2.1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"90","unit":"% IgG"},{"parameter":"Accuracy","value":"90","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.9","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"97.9","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"91.77","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"91.77","unit":"% IgM"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2049","commercial_name":"COVID-19 Ag Rapid Test Cassette","manufacturer":{"id_manufacturer":"944","name":"MedicalSystem Biotechnology Co. Ltd.","country":"China","website":"https:\/\/en.nbmedicalsystem.com\/en\/"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab","Oropharyngeal swab","Saliva","Throat swab"],"pathogen":[],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""}],"target":[],"notes":"N.A.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1727","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"150","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.33","unit":"%"},{"parameter":"False negatives","value":"7.33","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"90","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.67","unit":"%"},{"parameter":"Clinical Specificity","value":"98.67","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2526","commercial_name":"Medicovid-AG SARS-CoV-2 Antigen Schnelltest-Nase","manufacturer":{"id_manufacturer":"1080","name":"MEDICE Arzneimittel P\u00c3\u00bctter GmbH & Co. KG","country":"Germany","website":"www.medice.de"},"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":[{"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":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The test is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2230","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"130","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%"},{"parameter":"False negatives","value":"4","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.73","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.19","unit":"%"},{"parameter":"Clinical Specificity","value":"99.2","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2973","commercial_name":"MediDia COVID-19 Ag","manufacturer":{"id_manufacturer":"1312","name":"Medifood Hungary Innovation Kft.","country":"Hungary","website":"medidia.hu"},"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"],"pathogen":["SARS-CoV","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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"MediDia COVID-19 Ag is a rapid antigen test based on the license of the P4DETECT COVID-19 Ag rapid antigen test, manufactured by PRIME4DIA Co., Ltd. (South Korea). MediDia COVID-19 Ag is manufactured according to the same quality standards, using the same raw materials and production technology as those used in the production of P4DETECT COVID-19 Ag. MediDia COVID-19 Ag is identical to P4DETECT COVID-19 Ag.\r\nThere have been successful clinical studies carried out in multiple countries using P4DETECT COVID-19 Ag or STANDARD Q COVID-19 Ag, another rapid antigen test identical to P4DETECT COVID-19 Ag.","last_updated":"2022-09-20 10:58:53 CET","testList":[{"id_test":"5306","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"800","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%","info":"0 out of 334"},{"parameter":"False negatives","value":"2.63","unit":"%","info":"3 out of 114"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.33","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.37","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3954","commercial_name":"MEDsan\u00ae SARS-CoV-2 Ag Duo","manufacturer":{"id_manufacturer":"1434","name":"MEDsan\u00ae GmbH","country":"Germany","website":"https:\/\/www.medsan.eu\/en\/medsan-sars-cov-2-ag-duo\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Mid-turbinates swab","Nasal swab","Oropharyngeal swab","Saliva","Throat swab"],"pathogen":["SARS-CoV"],"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":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3620","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"N.A.","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"14.4","unit":"TCID50\/ml"},{"parameter":"Analytical Sensitivity","value":"98.4","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"3.3","unit":"%"},{"parameter":"Accuracy","value":"98.4","unit":"%"},{"parameter":"Clinical Sensitivity","value":"96.7","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1894","commercial_name":"COVID-19 Antigen Detection Test","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Automated","Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"COVID-19 Antigen Detection Test is a rapid immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab from human. For professional use.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1571","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"250","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.6","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2923","commercial_name":"COVIFIND COVID-19 Antigen Self Test","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal 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protein"],"notes":"Product is CE certified by the notifying body PCBC 1434","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2628","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"LOD of COVIFIND Covid-19 antigen Self Test is \u2265 933 TCID50\/ml."},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"The product is having zero False positive, specificity is 100%"},{"parameter":"False negatives","value":"1.75","unit":"%","info":"The product is having sensitivity of 98.25%, Gives 1.75% false negative results"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.25","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.25","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2924","commercial_name":"COVIFIND COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.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":[{"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Product is Self CE certified, notified with Obelis, the EU Rep","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2629","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","info":"LOD of COVIFIND Covid-19 antigen Self Test is \u2265 933 TCID50\/ml."},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"The product is having zero False positive, specificity is 100%"},{"parameter":"False negatives","value":"1.75","unit":"%","info":"The product is having sensitivity of 98.25%, Gives 1.75% false negative results"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.25","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.25","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2582","commercial_name":"MERISCREEN COVID-19 Antigen Detection Test","manufacturer":{"id_manufacturer":"461","name":"Meril Diagnostics Pvt Ltd.","country":"India","website":"www.merillife.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"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":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"The product is clinically tested, validated and approved by Indian council of medical research (ICMR). Notified with European Union with the EU Representative Obelis SA from Belgium having EAR certificate.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2287","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","info":"MERISCREEN COVID-19 Antigen Detection Test is \u2265 933 TCID50\/ml."},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"The product is having zero False positive, specificity is 100%"},{"parameter":"False negatives","value":"2.88","unit":"%","info":"The product is having sensitivity of 97.12%, Gives 2.88% false negative results"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.12","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.12","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2029","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette","manufacturer":{"id_manufacturer":"933","name":"Merlin Biomedical (Xiamen) Co. Ltd.","country":"China","website":"http:\/\/www.merlinbio.com.cn\/en\/"},"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":[],"target":["nucleocapsid protein"],"notes":"BfArM Vorgangsnummer: AT214\/20 Certificate T\u00dcV S\u00fcd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01\/1-16963-00006-IVD","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1707","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"160","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","unit":"AU"},{"parameter":"False negatives","value":"1","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.05","unit":"%"},{"parameter":"Clinical Specificity","value":"98.99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2596","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette","manufacturer":{"id_manufacturer":"1182","name":"Merlin Biomedical (Xiamen) Co. Ltd.","country":"China","website":"http:\/\/www.merlinbio.com.cn\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody"],"specimen":["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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"This cassette belongs to in vitro diagnostic reagents, and is suitable for the qualitative cietection cf SARS-CoV-2's Nucleocapsid protein in human saliva specimen. It cannot be served as the basis of the confirmation or exclusion for coronavirus pneumonia. This product is used only far medicai institutions. The positive test result requires further confirmation. A negative test cannot rule out the possibility of infection. The test results of this cassette are only for clinica! reference. It is recommended to conduct a comprehensive analysis of the patient's condition in combination with clinical manifestations and other laboratory tests. A total of 443 clinical samples were tested in this clinical study. The clear diagnosis and exclusion criteria of the \"SARS-CoV-2 diagnosis and treatment protocol\" were taken as a reference. Clinical trials were conducted at Fujian's Fuzhou Lung Hospital and Zhangzliou Hospital. The positive coincidence rate of the SARS-CoV-2 Antigen Rapid Test Cassette, developed by Merlin was 95.5% and the negative coincidence rate of the cassette was 99.7%, the total coincidence rate of the cassette was 98 , 4% compared to the reference method (RT-PCR) which indicates a high consistency.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2301","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4.5","unit":"%","info":"Positive coincidence rate = 127\/ (127+6) x100%=95.5%, (95% Cl: 90.5%-98.0%)"},{"parameter":"False negatives","value":"0.3","unit":"%","info":"Negative coincidence rate = 299\/ (299+1) x100%=99.7%, (95% Cl: 98.1%-99.9%);"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":" (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2030","commercial_name":"SARS-CoV-2 Antigen Rapid Test Cassette (saliva)","manufacturer":{"id_manufacturer":"933","name":"Merlin Biomedical (Xiamen) Co. Ltd.","country":"China","website":"http:\/\/www.merlinbio.com.cn\/en\/"},"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":"BfArM-Vorgangsnummer: AT790\/21 ISO 13485:2016 Certificate T\u00dcV S\u00fcd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01\/1-16963-00006-IVD","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1708","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"320","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6","unit":"AU"},{"parameter":"False negatives","value":"1","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.5","unit":"%"},{"parameter":"Clinical Specificity","value":"99.7","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1928","commercial_name":"ImmTek COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"882","name":"Metas Biomedical Inc.","country":"Taiwan ROC","website":"www.metasbiomedical.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":["Anterior nasal swab","Nasal swab","Nasopharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1224","lineage_name":"B.1.526","lineage_country":"Iota"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Prefilled buffer can inactivate coronavirus to avoid cross contamination.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1604","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":"10","performances":[{"parameter":"LOD","value":"313","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.46","unit":"AU"},{"parameter":"False negatives","value":"4.72","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.14","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.28","unit":"%"},{"parameter":"Clinical Specificity","value":"99.54","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2793","commercial_name":"COVID-19 Biokit IgG\/IgM","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The COVID-19 Biokit IgG\/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG\/IgM is suitable for professional use. The COVID-19 Biokit IgG\/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG\/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG\/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG\/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2498","assay_category":"Immuno-Antibody","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","info":"PRNT50: 20"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"9.91","unit":"%"},{"parameter":"False negatives","value":"0.25","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.74","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"90.09","unit":"%","info":"95% CI, 85.33% - 93.43%"},{"parameter":"Clinical Specificity","value":"99.75","unit":"%","info":"95% CI, 99.1% - 99.93%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"2827","commercial_name":"MiCo BioMed Co., Ltd.","manufacturer":{"id_manufacturer":"1254","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The COVID-19 Biokit IgG\/IgM is a single use lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 present in human capillary whole boold from patients suspected of COVID-19 infection. The COVID-19 Biokit IgG\/IgM is suitable for professional use. The COVID-19 Biokit IgG\/IgM is for in vitro diagnosis use only. The COVID-19 Biokit IgG\/IgM is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 Biokit IgG\/IgM should not be used as the sole basis for diagnosis. This assay only provides a preliminary result. A positive result does not necessarily mean a current infection but represents a different stage of the disease after infection. IgM positive or IgG\/IgM both positive suggest recent exposure, while IgG positive suggests previous infection, or latent infection. Current infection should be confirmed by Real-Time Reverse Transcriptase (RT-PCR) or viral gene sequencing.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2532","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","info":"PRNT50: 20"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"9.91","unit":"%"},{"parameter":"False negatives","value":"0.25","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.74","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"90.09","unit":"%","info":"95% CI, 85.33% - 93.43%"},{"parameter":"Clinical Specificity","value":"99.75","unit":"%","info":"95% CI, 99.1% - 99.93%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"2792","commercial_name":"VERI-Q COVID-19 Ag Rapid Test","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"The VERI-Q COVID-19 Ag Rapid Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swab and nasopharyngeal swab from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in sterilized swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The VERI-Q COVID-19 Ag Rapid Test is intended for use by medical professionals who are proficient in performing rapid lateral flowtests.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2497","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":"1000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"12.5","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.85","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":"95% CI: 86.3 % ~ 99.9 %"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"95% CI: 97.7 % - 100 %"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2791","commercial_name":"Veri-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit","manufacturer":{"id_manufacturer":"174","name":"MiCo Biomed Co. Ltd.","country":"South Korea","website":"www.micobiomed.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"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is a lateral flow immunoassay intended for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human plasma from anticoagulated blood, serum, finger-stick whole blood or venous whole blood samples. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2496","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Specificity","value":"95.6","unit":"%"}]}]},{"id_device":"2179","commercial_name":"ASAPath COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1015","name":"Microgenics Corporation","country":"United States","website":"www.thermofisher.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"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":[],"notes":"Subclass: Enzyme-linked and Sandwich. Limit of detection (LOD): 2237 TCID50\/mL (heat-inactivated virus).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1880","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Enzyme-linked","detection_principle":null,"subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"2237","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"Zero false positives."},{"parameter":"False negatives","value":"6","unit":"AU","info":"Six false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.1","unit":"%","info":" (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"80.6","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2123","commercial_name":"SARS-CoV-2 Antigen Rapid Test","manufacturer":{"id_manufacturer":"983","name":"MICROTRACE DIAGNOSTICI","country":"Italy","website":"www.microtrace.it"},"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","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":[],"notes":"The SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1813","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"See IFU"},{"parameter":"False negatives","info":"See IFU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.2","unit":"%","info":" (95%CI*: 91.3%~98.7%)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.9","unit":"%","info":" (95%CI*: 84.1%~97.6%)"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%","info":"\uff1e99.9% (95%CI*: 94.0%~100%)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1481","commercial_name":"Rapid SARS-CoV-2 Antigen Test Card","manufacturer":{"id_manufacturer":"367","name":"MP Biomedicals","country":"Germany","website":"https:\/\/www.mpbio.com\/eu\/"},"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","Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"We would like it to beupdated that the company is MP Biomedicals Germany GmbH and also refer to the EU website that is in this update. What is currently online directs people to the USA company.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1232","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.25","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.17","unit":"%"},{"parameter":"Clinical Specificity","value":"99.16","unit":"%"},{"parameter":"Type of antigen","info":"nucleoprotein"}]}]},{"id_device":"2532","commercial_name":"MSP SARS-CoV-2 Antigen 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CET","testList":[{"id_test":"2237","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1.51","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.52","unit":"%","info":"Oropharyngeal"},{"parameter":"False positives","value":"0.33","unit":"%","info":"Nasopharyngeal"},{"parameter":"False positives","value":"0.52","unit":"%","info":"Nasal"},{"parameter":"False negatives","value":"1.32","unit":"%","info":"Oropharyngeal"},{"parameter":"False negatives","value":"1.22","unit":"%","info":"Nasopharyngeal"},{"parameter":"False 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This test is validated by the Belgian Health agency : https:\/\/www.famhp.be\/en\/human_use\/health_products\/medical_devices_accessories\/covid_19\/tests","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1959","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"30","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.7","unit":"%","info":"(NPA 99.3%)"},{"parameter":"False negatives","value":"6.8","unit":"%","info":" (PPA 93.18%, 100% for Ct values \u226433)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.57","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.18","unit":"%","info":" (100% for Ct values \u226433)"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2262","commercial_name":"Covid19Check-MG","manufacturer":{"id_manufacturer":"1052","name":"Multi-G bvba","country":"Belgium","website":"www.covid19check-mg.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"All additional data is available on demand. This test is validated by the French Health agency : https:\/\/covid-19.sante.gouv.fr\/tests#e786994f-fc19-4c68-a3f5-74ce44fc3bb7","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1963","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"22.5","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%","info":"(NPA 97%)"},{"parameter":"False negatives","value":"7","unit":"%","info":"(PPA 93%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2260","commercial_name":"Covid19Check-NAS","manufacturer":{"id_manufacturer":"1052","name":"Multi-G bvba","country":"Belgium","website":"www.covid19check-mg.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"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"All additional data is available on demand. This test is validated by the Belgian Health agency : https:\/\/www.famhp.be\/en\/human_use\/health_products\/medical_devices_accessories\/covid_19\/tests","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1961","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1600","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.5","unit":"%","info":" (NPA 99.5%)"},{"parameter":"False negatives","value":"3","unit":"%","info":" (PPA 97%, 99.35% for Ct values \u226425)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97","unit":"%","info":" (99.35% for Ct values \u226425)"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2261","commercial_name":"Covid19Check-SAL","manufacturer":{"id_manufacturer":"1052","name":"Multi-G bvba","country":"Belgium","website":"www.covid19check-mg.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"All additional data is available on demand. 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Each variant listed as \u201cvariant of concern\u201d and \u201cvariant of interest\u201d by World Health Organization (WHO) will be studied since the date of listing.  And the study procedure is as follows:\r\nStep one: In-silico analysis\r\nNote: In in-silico analysis, the overlap of mutation site of new variant and the epitope of antibodies used in the test will be analyzed to identify potential impact on the performance of test kit.\r\nStep two:  Validation of Limit of Detection (LOD) in form of TCID50\/mL, if necessary\r\nStep three:Clinical performance validation of Positive Percent Agreement (PPA), if necessary","last_updated":"2022-09-21 08:27:37 CET","testList":[{"id_test":"5378","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":"Detection Kit","time_minutes":"10","performances":[{"parameter":"LOD","value":"10000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%","info":"0.00% (Nasal Swab) 0.22% (Nasopharyngeal Swab)"},{"parameter":"False negatives","value":"6","unit":"%","info":"6.00% (Nasal Swab) 5.50% (Nasopharyngeal Swab)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.15","unit":"%","info":"98.15% (Nasal Swab) 98.15%  (Nasopharyngeal Swab)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%","info":"94.00% (Nasal Swab) 94.50% (Nasopharyngeal Swab)"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"100.00% (Nasal Swab) 99.78% (Nasopharyngeal Swab)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein; Spike protein"}]}]},{"id_device":"3107","commercial_name":"Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) -  Nasal swab","manufacturer":{"id_manufacturer":"184","name":"Nanjing Vazyme Medical Technology Co. 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The product has also obtained the CE 1434 certificate issued by the notified body, and has entered the recommended list of self-test antigen kit in French , Switzerland ,Belgium,Spain.","last_updated":"2022-12-05 09:31:40 CET","testList":[{"id_test":"5374","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":"Detection Kit","time_minutes":"10","performances":[{"parameter":"LOD","value":"10000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%"},{"parameter":"False negatives","value":"6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.15","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2983","commercial_name":"Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - self-testing","manufacturer":{"id_manufacturer":"184","name":"Nanjing Vazyme Medical Technology Co. 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Each variant listed as \u201cvariant of concern\u201d and \u201cvariant of interest\u201d by World Health Organization (WHO) will be studied since the date of listing.  And the study procedure is as follows:\r\nStep one: In-silico analysis\r\nNote: In in-silico analysis, the overlap of mutation site of new variant and the epitope of antibodies used in the test will be analyzed to identify potential impact on the performance of test kit.\r\nStep two:  Validation of Limit of Detection (LOD) in form of TCID50\/mL, if necessary.\r\nStep three:Clinical performance validation of Positive Percent Agreement (PPA), if necessary.","last_updated":"2022-11-03 08:47:43 CET","testList":[{"id_test":"5277","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":"Detection Kit","time_minutes":"10","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"%"},{"parameter":"False negatives","value":"6","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.15","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein (N) Spike protein (S"}]}]},{"id_device":"2200","commercial_name":"NanoRepro SARS-CoV-2 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1027","name":"NanoRepro AG","country":"Germany","website":"https:\/\/www.nanorepro.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":[],"lineage":[],"target":[],"notes":"Dear Sir\/Madam, We, NanoRepro AG, are manufacturer of SARS-CoV-2 Antigen Rapid Test in Germany and would like to request you to add our product in your European Commision Common List of Rapid Antigen Tests. Our NanoRepro SARS-CoV-2 Antigen Rapid Test carries CE marking, have sensitivity \u2265 90% and specificity \u2265 97% and has been successfully validated in Germany according to the criteria of Paul Ehrlich Institute (PEI) by Biomex GmbH . This validation ,which was performed by Biomex GmbH , Heidelberg, has been accepted by Bundesinstitute f\u00fcr Arzneimittel und Medizinprodukte and Paul Ehrlich Institute. We look forward to receiving a positive response. Best Regards Ramila Sedai Regulatory Affairs Manager NanoRepro AG","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1901","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"30","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.63","unit":"%","info":"Among 550 specimens, 9 test results were false positives."},{"parameter":"False negatives","value":"2.8","unit":"%","info":"Among 250 specimens, 7 test results were false regatives."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.2","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"98.4","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1617","commercial_name":"COVID-19 Antigen Saliva Test Kit (Colloidal Gold)","manufacturer":{"id_manufacturer":"851","name":"Nantong Diagnos Biotechnology Co. 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protein"],"notes":"Please use following Email to respond: B.Grunberg@acura-kliniken.com Thank you.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1297","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"115","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.82","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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CET","testList":[{"id_test":"2049","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":"20","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"5.7","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2349","commercial_name":"KIT REVOLUTION 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CET","testList":[{"id_test":"2050","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":"25","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Not evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"8","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2678","commercial_name":"ND COVID-19 Ag 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S\u00c4\u00b0S. MED. PLAS. ENJEK. \u00c4\u00b0ML. \u00c4\u00b0TH. \u00c4\u00b0HR. SAN. T\u00c4\u00b0C. 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This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. An antigen is generally detectable in upper respiratory specimen during the acute phase of the infection (within the first 5 to 7 days from symptom onset). The Novacheck SARS-CoV-2 rapid diagnostic test can be used in symptomatic and asymptomatic people for lay users.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1441","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1.7","unit":"U\/ml"},{"parameter":"Analytical Sensitivity","value":"97.54","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"(0\/517 with negative PCR result There was no false positiv sample from the sample)"},{"parameter":"False negatives","value":"4.09","info":"(14\/342 positive PCR result 14 false negative samples did not come out of the sample) "},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2157","commercial_name":"SARS CoV-2 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1001","name":"Novatech T\u00c4\u00b1bbi Cihaz \u00c3\u0153r\u00c3\u00bcnleri Sanayi ve Ticaret A.\u00c5\u017e.","country":"Turkey","website":"www.novadiag.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":["Anterior nasal swab","Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"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":"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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Intended Use The Novacheck SARS-CoV-2 rapid diagnostic test is an immunochromatographic per-patient test based on the sandwich principle, which contains two specific antibodies for qualitative detection of N-protein antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. An antigen is generally detectable in upper respiratory specimen during the acute phase of the infection (within the first 5 to 7 days from symptom onset). The Novacheck SARS-CoV-2 rapid diagnostic test can be used in symptomatic and asymptomatic people for lay users.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1858","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":"15","performances":[{"parameter":"LOD","value":"1.7","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"517 with negative PCR result There was no false positiv sample from the sample. 0\/517"},{"parameter":"False negatives","value":"4.09","unit":"%","info":"342 positive PCR result 14 false negative samples did not come out of the sample. 14\/342"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.37","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.91","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"N-protein"}]}]},{"id_device":"2868","commercial_name":"Surety","manufacturer":{"id_manufacturer":"1274","name":"Nulife","country":"India","website":"nulifecare.in"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"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":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1224","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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["non-structural protein NSP1","non-structural protein NSP10","non-structural protein NSP12","non-structural protein NSP13","non-structural protein NSP14","non-structural protein NSP15","non-structural protein NSP16","non-structural protein NSP2","non-structural protein NSP3","non-structural protein NSP4","non-structural protein NSP5","non-structural protein NSP6","non-structural protein NSP7","non-structural protein NSP8","non-structural protein NSP9","nucleocapsid protein","spike protein"],"notes":"The test has been CE approved by Global Euro Accreditation Centre. It is manufactured in India by NuLife (IS09001\/2015 & CMP certified company) under contract for E.J. Bodkin + Co, Dublin, Ireland. Accuracy rates are independently assessed and verified by Indian government.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2573","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":null,"subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.4","unit":"%","info":"98.6"},{"parameter":"False negatives","value":"0","unit":"%","info":"100"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.6","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.6","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2202","commercial_name":"OFM GmbH","manufacturer":{"id_manufacturer":"1029","name":"OFM Medical","country":"Germany","website":"www.OFM-Medical.de"},"ce_marking":"No","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["Antigen"],"specimen":null,"pathogen":[],"lineage":[],"target":[],"notes":"Test zur Eigenanwendung \u2013 nach \u00a7 11MPG befristete Sonderzulassung durch BfArM, Aktenzeichen 5640-S-140\/21 -> CE Certification is under progress -> until then special confirmation from BfArM","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1903","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"65","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"1.86","unit":"%","info":"(4 of 214)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2171","commercial_name":"SIMPLE IgA\/IgM\/IgG SARS-CoV-2","manufacturer":{"id_manufacturer":"776","name":"OPERON S.A.","country":"Spain","website":"https:\/\/operondx.com\/molecular-diagnostics\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC","Semi-automated"],"target_type":["Antibody","IgG","IgM","IgA"],"specimen":["Other","Serum","Whole blood"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Interpretaci\u00f3n de resultados: visual \u00f3 autom\u00e1tica con el LF OPERON reader. SENSIBILIDAD Y ESPECIFICIDAD DIAGN\u00d3STICA > 6 d\u00edas Sensibilidad: 96,3% (Ig tot); 92,5% (IgA), 91,3% (IgG), 91,3% (IgM) Especificidad: 96,7% (Ig tot); 98,4% (IgA), 100% (IgG), 98,3% (IgM) Precisi\u00f3n: 96,5% (Ig tot); 95% (IgA), 95% (IgG), 94,3% (IgM) >15 d\u00edas Sensibilidad: 96,9% (Ig tot); 93,8% (IgA), 96,9% (IgG), 92,3% (IgM) Especificidad: 96,7% (Ig tot); 98,4% (IgA), 100% (IgG), 98,3% (IgM) Precisi\u00f3n: 96,8% (Ig tot); 96% (IgA), 98,4% (IgG), 95,2% (IgM)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1872","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0.04","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%","info":"(Ig tot)"},{"parameter":"False positives","value":"1.7","unit":"% IgM"},{"parameter":"False positives","value":"0","unit":"% IgG"},{"parameter":"False positives","value":"1","unit":"% IgA"},{"parameter":"False negatives","value":"3","unit":"%","info":" (Ig tot)"},{"parameter":"False negatives","value":"7","unit":"% IgM"},{"parameter":"False negatives","value":"3","unit":"% IgG"},{"parameter":"False negatives","value":"6","unit":"% IgA"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"% IgM"},{"parameter":"Accuracy","value":"96","unit":"%","info":"(Ig tot)"},{"parameter":"Accuracy","value":"98","unit":"% IgG"},{"parameter":"Accuracy","value":"96","unit":"% IgA"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%","info":" (Ig tot)"},{"parameter":"Clinical Sensitivity","value":"93"},{"parameter":"Clinical Sensitivity","value":"96"},{"parameter":"Clinical Sensitivity","value":"92"},{"parameter":"Clinical Specificity","value":"96","unit":"%","info":" (Ig tot)"},{"parameter":"Clinical Specificity","value":"98","unit":"% IgA"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"98","unit":"% IgM"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2170","commercial_name":"SIMPLE\/STICK Ag SARS-CoV-2","manufacturer":{"id_manufacturer":"776","name":"OPERON S.A.","country":"Spain","website":"https:\/\/operondx.com\/molecular-diagnostics\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC","Other","Semi-automated"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Other"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Interpretaci\u00f3n de resultados: visual \u00f3 autom\u00e1tica con el OPERON LF reader LOD: 6 x 10^2 TCID50\/mL (1.63 x 10^5 copias\/mL) SENSIBILIDAD Y ESPECIFIDAD DIAGN\u00d3STICA: Ref: SARS-CoV-2 Rapid Antigen Test de Roche Concordancia total : 99.4% Concordancia Sensibilidad: 96.4% Concordancia Especificidad: 100% Ref: RT-PCR (Real SARS-CoV-2, OPERON S.A.) Concordancia total: 95.1% Concordancia Sensibilidad: 77.5% \u2022 Para Ct\u226430: 96.7% \u2022 Para Ct\u226425: >99.9% Concordancia Especificidad: 100% Ref: Diagn\u00f3stico cl\u00ednico Sensibilidad diagn\u00f3stica: 95.0% Especificidad diagn\u00f3stica: 100%","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1871","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":"600","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"3","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2271","commercial_name":"Pantest Coronavirus Ag (Nasopharyngeal Swab)","manufacturer":{"id_manufacturer":"599","name":"Pantest SA","country":"Portugal","website":"www.pantest.pt"},"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":"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Registered in Infarmed in Portugal","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1972","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"39.51","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.92","unit":"%","info":"In 326 samples evaluated, 3 tests are false positives"},{"parameter":"False negatives","value":"3.98","unit":"%","info":"In 326 samples, 13 are false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.7","unit":"%"},{"parameter":"Clinical Specificity","value":"99.1","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2243","commercial_name":"PCL COVID19 Ag Gold","manufacturer":{"id_manufacturer":"202","name":"PCL Inc.","country":"South Korea","website":"www.pclchip.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","Nasopharyngeal swab","Saliva"],"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":"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":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"Compatible with Saliva specimen, NP Swab Specimen & Nasal Specimen","last_updated":"2022-08-24 15:42:41 CET","testList":[{"id_test":"3704","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"562","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"9.7","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.52","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.83","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"3694","commercial_name":"PCL SELF TEST - COVID19 Ag","manufacturer":{"id_manufacturer":"1043","name":"PCL Inc.","country":"South Korea","website":"www.pclchip.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Saliva"],"pathogen":["SARS-CoV"],"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":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1223","lineage_name":"B.1.525","lineage_country":"Eta"},{"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":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3377","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"562","unit":"TCID50\/ml"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"False positives","value":"0.3","unit":"%"},{"parameter":"False negatives","value":"9.9","unit":"%"},{"parameter":"Accuracy","value":"97.31","unit":"%"},{"parameter":"Clinical Sensitivity","value":"90.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.68","unit":"%"}]}]},{"id_device":"310","commercial_name":"SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)","manufacturer":{"id_manufacturer":"204","name":"PerGrande BioTech Development Co. Ltd.","country":"China","website":"www.pergrande.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":null,"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"262","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":null,"performances":[]}]},{"id_device":"2116","commercial_name":"SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)","manufacturer":{"id_manufacturer":"981","name":"PerGrande BioTech Development Co. Ltd.","country":"China","website":"www.pergrande.com.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":"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"}],"target":["nucleocapsid protein"],"notes":"Please review, thanks.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1806","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"20","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.89","unit":"%"},{"parameter":"False negatives","value":"5.72","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.41","unit":"%","info":"( 95.24%-97.30%)\uff08Antigen\uff09"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.28","unit":"%","info":"( 92.33%-95.76% )\uff08Antigen\uff09"},{"parameter":"Clinical Specificity","value":"99.11","unit":"%","info":"( 97.94%-99.62%)\uff08Antigen\uff09"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2121","commercial_name":"SARS-CoV-2 Antigen Detection Kit (Sampling by gargle or oropharyngeal wash)","manufacturer":{"id_manufacturer":"981","name":"PerGrande BioTech Development Co. 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Product Information Product Name COVID-19 Ag Test Trade Name Rapidigen Product Code PHRPD 2020 Manufacturer Pharmaline Saglik Hizmetleri Ticaret A.S. Address Headquarter: Atat\u00fcrk Caddesi, Atat\u00fcrk Caddesi Konutlari, No: 43 A Blok Daire 6 Sahrayicedit-Kadik\u00f6y, 34734 Istanbul, Turkey. Factory: Bati Sitesi Mah. 2308 Cad. Gersan Sit. No.: 52, Yenimahalle, Ankara, Turkey. 2. Product Description Single-use cassette test for professional in vitro diagnostic usage. 3. Classification according to 98\/79\/EC In-vitro Diagnostic Medical Devices Professional Use IVD, 98\/79\/EC. 4. Intended Use Rapidigen COVID-19 Ag Test is used for in vitro qualitative detection of novel coronavirus antigen in human throat swabs or nasal swabs. 5. Sample Type Human throat or nasal swab. 6. Reagents This test included 2019- nCoV antibody, anti-chicken IgY polyclonal antibody, chicken IgY and colloidal gold conjugate. 7. Analysis Method Rapidigen COVID-19 Ag Test is a rapid, qualitative, immunochromatographic assay for detecting the 2019-nCoV antigen in human oropharyngeal or nasopharyngeal swabs. The sample will be under the capillary action to move forward along the test cassette when it contains a new antigen crown at a detectable level. The antigens with colloidal gold labeling are coronavirus monoclonal antigens\u2014the complex immune fixes on the membrane. If the coronavirus monoclonal antibody forms the colored line, the visualization is positive for the coronavirus antigen; If the line does not show color, the result is negative. A colored line will always appear in the control line region, indicating that the proper specimen volume has been added and membrane wicking has occurred. 8. Performance Evaluation Rapidigen COVID-19 Ag Test has been evaluated using clinical samples. PCR methods are used to compare Rapidigen COVID- 19 Ag Test, and the following results are obtained. \u2003 8.1. Sensitivity & Specificity Rapidigen COVID - 19 Ag Test PCR Test Total Positive Negative Positive 164 3 167 Negative 12 438 450 Total 176 441 617 Analysis of coincidence rate of Rapidigen COVID-19 Ag Test and PCR Test in nasal samples: Sensitivity: 164\/ (164+12) \u00d7 100% = 93.18% Specificity: 438 \/ (3+438) \u00d7 100% = 99.32% Accuracy: (164+438) \/ (164+12+3+438) \u00d7 100% = 97.57% 8.2. Interferences Samples containing Mucin, Hemoglobin, Histamine Hydrochloride, Human albumin, \u03b1- interferon, Lopinavir, Tobramycin, Ribavirin, Tramadol, Azithromycin, Meropenem, Oseltamivir, Benzocaine, Peramivir in different concentrations do not affect the test result. Test results present no interference. 8.3. Cross-Reactivity This product does not cross-react with pathogens of HKU1, OC43, NL63, 229E, MERS Coronavirus, Human Metapneumovirus, Influenza A virus H1N1, Influenza A virus H3N2, Influenza A virus H5N1, Influenza A virus H7N9, Influenza B virus, Mycoplasma pneumonia, Rhinovirus A, Rhinovirus B, Rhinovirus C, Staphylococcus aureus, Adenovirus 1, Adenovirus 2, Adenovirus 3, Adenovirus 4, Adenovirus 5, Adenovirus 7, Adenovirus 55, Enterovirus A, Enterovirus B, Enterovirus C, Enterovirus D, EB Virus, Measles virus, Human cytomegalovirus, Rotavirus, Norovirus, Mumps virus, Varicella-zoster virus, Respiratory syncytial virus, Mycoplasma pneumonia, and Escherichia Coli. 9. Packaging Consumer package includes: a) Primary package: An aluminum pouch including test cassette and silica gel. b) Secondary package: Carton box including tests in aluminum pouches, sterile swab, sample extraction tube, extraction tube tips, extraction reagent (R), workstation and instructions for use sheet. Packing instructions, labeling and symbols are prepared according to the 98\/79\/EC in-vitro diagnostic medical device directive, harmonized standards. c) The transportation package is a carton package covered with strong nylon film to provide extra protection for the products during transportation and storage. 10. Kit components Test cassettes, sterile swab, sample extraction tube, extraction tube tips, extraction reagent (R), workstation and instructions for use. 11. Storage & Shelf Life Store at 4 - 30\u00b0C (39 - 86\u00b0F); maximum 24 months 12. Transportation Truck or aircraft freight. Transport conditions should be between 4-30\u00b0C (39 - 86\u00b0F).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1501","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Magnetic Electrochemical","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"30","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Sample contamination or not following the IFU protocol"},{"parameter":"False negatives","info":"Sample contamination or not following the IFU protocol"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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It is mainly used to identify individuals with acquired immune response to the SARS-CoV-2, and to evaluate the effectiveness of the vaccine clinical trials and mass vaccination.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2621","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"98.31","unit":"%","info":"Neutralizing antibody"},{"parameter":"LOD","value":"98.31","unit":"%","info":"Total Antibody"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.38","unit":"%","info":"Total Antibody"},{"parameter":"False positives","value":"4.76","unit":"%","info":"Neutralizing Antibody"},{"parameter":"False 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with 4 different specimens"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.41","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.27","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2197","commercial_name":"(SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 \/ Saliva","manufacturer":{"id_manufacturer":"1025","name":"Pierenkemper GmbH","country":"Germany","website":"https:\/\/covident.health\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab","Nasopharyngeal swab","Oropharyngeal swab","Throat 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different specimens"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.41","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.27","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2583","commercial_name":"POLOFLUOR 2","manufacturer":{"id_manufacturer":"1177","name":"Polonord Adeste Srl","country":"Italy","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"POLOFLUOR 2 is a membrane fluorescence qualitative test for the detection of SARS-Cov-2 nucleocapsid protein antigen in the human rhinopharyngeal swab sample. The COVID-19 antigen test cassette (nasopharyngeal swab) is capable of detecting SARS-COV-2 heat inactivated viral strain from 1 x 102 TCID50\/ml. Other studies on performance characteristics: - Detection Level Determination - Interfering Substances - Specificity Testing with Strains - Dose Hook Study - Variability (Inter\/Intra\/Day to day assay) - Reading Time Flex Study - Specimen Volume Flex Study - Open Pouch Stability Study - Accelerated Stability Study","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2288","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Fluorescence","subcategory":null,"time_minutes":"10","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5.4","unit":"%","info":"8\/148"},{"parameter":"False negatives","value":"0.46","unit":"%","info":"1\/217"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Accuracy","value":"97.5","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2467","commercial_name":"PBCheck COVID-19 Ag","manufacturer":{"id_manufacturer":"1124","name":"Precision Biosensor","country":"South Korea","website":"www.precision-bio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":[],"notes":"PBCheck COVID-19 Ag is a rapid immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal or nasopharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The PBCheck COVID-19 Ag is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures and individuals similarly trained in point of care settings.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2170","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Enzyme-linked","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"1510","unit":"TCID50\/ml","info":"(1.51 x 103 TCID50\/mL)"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Positive Percent Agreement (PPA, %) = (90\/100) \u2179 100 = 90.0% (Wilson 95% CI: 82.6-94.5)"},{"parameter":"False negatives","info":"Negative Percent Agreement (NPA, %) = (108\/108) \u2179 100 = 100% (Wilson 95% CI: 96.6-100)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.19","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2299","commercial_name":"SURE STATUS COVID-19 ANTIGEN CARD TEST","manufacturer":{"id_manufacturer":"1072","name":"PREMIER MEDICAL CORPORATION PRIVATE LIMITED","country":"India","website":"www.premiermedcorp.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"LOD: 250 pfu\/ml ~ 353 TCID50\/ml","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2000","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"353","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False negatives","value":"9","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","info":"91% SENSTIVITY AND 97% SPECIFICITY In comparison with the RT-PCR"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2570","commercial_name":"2019-nCoV Antigen Device (Anterior Nasal Swab)","manufacturer":{"id_manufacturer":"1172","name":"Prestige Diagnostics UK Ltd.","country":"United Kingdom","website":"www.prestigediagnostics.co.uk"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":[],"notes":"The 2019-nCoV Antigen Device (Anterior Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen of SARS-CoV-2 in anterior nasal swab samples.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2275","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"625","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.5","unit":"%"},{"parameter":"False negatives","value":"3.7","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.3","unit":"%"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1070","commercial_name":"2019-nCoV IgG\/IgM Rapid Test","manufacturer":{"id_manufacturer":"575","name":"Prestige Diagnostics UK Ltd.","country":"United Kingdom","website":"www.prestigediagnostics.co.uk"},"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":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"846","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0","unit":"AU","info":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"% IgG"},{"parameter":"Accuracy","value":"96.7","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.8","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"95.7","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"96.4","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"97.3","unit":"% IgM"}]}]},{"id_device":"2227","commercial_name":"2019-nCoV Neutralising Antibody","manufacturer":{"id_manufacturer":"1035","name":"Prestige Diagnostics UK Ltd.","country":"United Kingdom","website":"https:\/\/www.prestigediagnostics.co.uk\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual","Near POC \/ POC"],"target_type":["Antibody"],"specimen":["Peripheral blood","Plasma","Serum","Venous whole blood","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[],"target":[],"notes":"The 2019-nCoV Neutralization Antibody device is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against viral spike glycoprotein","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1928","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"500","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.29","unit":"%","info":"(3\/131)"},{"parameter":"False negatives","value":"2.27","unit":"%","info":"(2\/88)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.7","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.6","unit":"%"},{"parameter":"Clinical Specificity","value":"98.5","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2686","commercial_name":"COVID-19 Antigen Professional Rapid Test","manufacturer":{"id_manufacturer":"1228","name":"PRIMA Lab SA","country":"Switzerland","website":"https:\/\/primahometest.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":["Anterior nasal swab","Nasopharyngeal swab"],"pathogen":["SARS-CoV"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"COVID-19 Antigen Professional Rapid Test was tested with the following viral strains, no cross-reaction was observed at the following concentrations: - MERS 1.17x10^5 TCID50\/mL - NL63 4.68x10^4 TCID50\/mL - OC43 5.01x10^5 TCID50\/mL - 229E 1.41x10^5 TCID50\/mL - Adenovirus 7A (species B) 1.02x10^8 TCID50\/mL - Parainfluenza Virus Type 1 9.12x10^8 TCID50\/mL - Parainfluenza Virus Type 2 4.17x10^5 TCID50\/mL - Parainfluenza Virus Type 3 2.57x10^8 TCID50\/mL - Parainfluenza Virus Type 4 1.41x10^5 TCID50\/mL - Rhinovirus 1A 1.70x10^5 TCID50\/mL - Influenza A H1N1 New Caledonia\/20\/99 4.17x10^5 TCID50\/mL - Influenza B Florida\/02\/06 4.68x10^4 TCID50\/mL - Respiratory Syncytial Virus Type B (RSV-B) CH93-18(18) 1.55x10^4 TCID50\/mL - Enterovirus Type 71 2003 Isolate (cell line LLC-mk2) 1x10^5.86 TCID50\/mL - Human Metapneuomovirus 16 (hMPV-16) Type A1 IA10-2003 3.8x10^6 TCID50\/mL - Recombinant Nucleocapsid SARS-CoV (2003) 1.24 mg\/mL","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2391","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","performances":[{"parameter":"LOD","value":"102000","unit":"TCID50\/ml","info":"600 pg\/mL of recombinant nucleocapsid protein"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"N.A."},{"parameter":"False negatives","info":"N.A."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.1","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.3","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2685","commercial_name":"COVID-19 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1228","name":"PRIMA Lab SA","country":"Switzerland","website":"https:\/\/primahometest.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"],"pathogen":[],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"}],"target":["nucleocapsid protein"],"notes":"COVID-19 ANTIGEN RAPID TEST was tested with the following viral strains, no cross-reaction was observed at the following concentrations: Adenovirus type 3 3.16 x 10^4 TCID50\/ml Influenza B 3.16 x 10^6 TCID50\/ml Adenovirus type 7 1.58 x 10^5 TCID50\/ml Human Rhinovirus 2 2.81 x 10^4 TCID50\/ml Human Coronavirus OC43 1 x 10^6 TCID50\/ml Human Rhinovirus 14 1.58 x 10^6 TCID50\/ml Human Coronavirus 229E 5 x 10^5 TICID50\/ml Human Rhinovirus 16 8.89 x 10^6 TCID50\/ml Human Coronavirus NL63 1 x 10^6 TICID50\/ml Masern-Virus 1.58 x 10^4 TCID50\/ml Human Coronavirus HKU1 1 x 10^6 TICID50\/ml Mumps-Virus 1.58 x 10^4 TCID50\/ml MERS COV Florida 1.17 x 10^4 TICID50\/ml Parainfluenza virus 2 1.58 x 10^7 TCID50\/ml Influenza A H1N1 3.16 x 10^5 TCID50\/ml Parainfluenza virus 3 1.58 x 10^8 TCID50\/ml Influenza A H3N2 1 x 10^5 TCID50\/ml Respiratory syncytial virus 8.89 x 10^4 TCID50\/ml Hangzhou Alltest Biotech CO., Ltd is the contract OEM manufacturer of COVID-19 Antigen Rapid Test which is already on the Common list of rapid antigen tests (JRC Device ID 1257).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2390","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"N.A."},{"parameter":"False negatives","info":"N.A."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.6","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1975","commercial_name":"COVID-19 IgG Spike Self Test","manufacturer":{"id_manufacturer":"808","name":"PRIMA Lab SA","country":"Switzerland","website":"primahometest.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["IgG"],"specimen":["Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The performance of the device to recognize IgG post-Vaccination have been clinically evaluated. The EC mark for self testing is available (approved by Notified Body 0483)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1651","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"93.75","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Possible cross-interferences were observed: Ad V IgG, Ad V IgM, RF IgG, antinuclear Ab, HCV IgG"},{"parameter":"False negatives","info":"No hook effect has been observed"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.5","unit":"% IgG","info":"After infection 96.5% (Wilson 95% Cl: 94.9%-98.13%), after vaccination > 98% at 35 days, C.I. 95%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.6","unit":"% IgG","info":"Sensitivity after infection 92.6%(sensitivity after vaccination 98.3% at 35 days, C.I. 95%)"},{"parameter":"Clinical Specificity","value":"97.4","unit":"% IgG","info":"on pre-outbreak samples 97.4% (C.I. 95%)"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"1875","commercial_name":"COVID-19 NEUTRALISING Ab RAPID TEST","manufacturer":{"id_manufacturer":"808","name":"PRIMA Lab SA","country":"Switzerland","website":"primahometest.com\/en\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG"],"specimen":["Plasma","Serum","Venous whole blood","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"The performance of the device to recognize IgG post-Vaccination have been clinically evaluated.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1556","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"93.75","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"Possible cross-interferences were observed: Ad V IgG, Ad V IgM, RF IgG, antinuclear Ab, HCV IgG"},{"parameter":"False negatives","info":"No hook effect has been observed"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.5","unit":"% IgG","info":"After infection 96.5 % (Wilson 95% Cl: 94.9%-98.13%), after vaccination > 98% at 35 days, C.I. 95%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.6","unit":"% IgG","info":"Sensitivity after infection 92.6%(sensitivity after vaccination 98.3% at 35 days, C.I. 95%)"},{"parameter":"Clinical Specificity","value":"97.4","unit":"% IgG","info":"Specificity on pre-outbreak samples 97.4% (C.I. 95%)"}]}]},{"id_device":"321","commercial_name":"P4DETECT COVID-19 Ag","manufacturer":{"id_manufacturer":"1349","name":"PRIME4DIA Co. Ltd.","country":null,"website":null},"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":["Nasopharyngeal swab","Oropharyngeal swab"],"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":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"P4DETECT COVID-19 Ag is a qualitative, lateral flow immunoassay for the detection of specific antigens Coronavirus in nasopharyngeal specimens. In this test, antibody specific to the SARS-CoV-2 antigen is separately coated on the test line regions of the test device. During testing, the extracted specimen reacts with the antibody to SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibody to SARS-CoV-2 on the membrane and generate one colored lines in the test regions. If SARS-CoV-2 antigens are present in the specimen a colored test line would be visible in the result window. If SARS-CoV-2 antigens are not present in the specimen, then no color appears in the test line.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"269","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"800","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"AU"},{"parameter":"False negatives","value":"3.3","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.33","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"96.67","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3103","commercial_name":"Q-Sens\u00ae COVID-19 Ag","manufacturer":{"id_manufacturer":"208","name":"PRIME4DIA Co. Ltd.","country":"South Korea","website":"https:\/\/prime4dia.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":["Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":["SARS-CoV"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Distributor : Dx&Vx Co.,Ltd.","last_updated":"2022-08-24 09:08:01 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protein"],"notes":"Der verwendete polyklonale Antik\u00f6rper ist gegen das Nukleocapsidprotein gerichtet und insofern von den meisten Mutationen, die im Spikeprotein statfinden, nicht beeinflusst.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1915","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"30","performances":[{"parameter":"LOD","value":"237","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"bei hohen Konzentrationen an S.aureus (> 5 Mio Keime\/ml)"},{"parameter":"False negatives","info":"bei Antigenkonzentrationen unterhalb 237 TCID50\/ml"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%"},{"parameter":"Clinical Specificity","value":"97","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"5812","commercial_name":"SARS-CoV-2 Antigen Rapid Test  (Nasal Swab)","manufacturer":{"id_manufacturer":"1375","name":"Rapid Labs Ltd.","country":"United Kingdom","website":"www.rapidlabs.co.uk"},"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":["Adenovirus 3","Adenovirus 7","Alpha Coronavirus 229E (HCoV-229E)","Alpha Coronavirus Nl63 (HCoV-Nl63)","Beta Coronavirus HKU1 (HCoV-HKU1)","Beta Coronavirus OC43 (HCoV-OC43)","Influenza A H1N1","Influenza A H3N2","Influenza B","MERS-CoV","Mumps Virus (MuV)","Parainfluenza Virus Type 2","Parainfluenza Virus Type 3","Respiratory Syncytial V (RSV)"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid 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Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole \r\nbasis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. \r\nNegative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2023-01-09 10:03:34 CET","testList":[{"id_test":"20273","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":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"95.3","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.047","unit":"AU"},{"parameter":"False negatives","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.7","unit":"%"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.3","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"}]}]},{"id_device":"1962","commercial_name":"BIOCREDIT COVID-19 Ag","manufacturer":{"id_manufacturer":"220","name":"RapiGEN Inc.","country":"South Korea","website":"www.rapigen-inc.com\/eng"},"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"],"pathogen":["SARS-CoV"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"BIOCREDIT COVID-19 Ag is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in human nasopharynx. This test is for in-vitro professional diagnostic use and intended as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms. It provides only an initial screening test result and more specific alternative diagnosis methods should be performed in order to confirm COVID-19 infection. BIOCREDIT COVID-19 Ag has been evaluated with clinical nasopharyngeal specimens which were identified with the RT-PCR test in Korea and Romania.","last_updated":"2022-10-05 14:00:56 CET","testList":[{"id_test":"3931","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"562","unit":"PFU\/mL"}]}]},{"id_device":"1963","commercial_name":"BIOCREDIT COVID-19 Ag Test Nasal","manufacturer":{"id_manufacturer":"220","name":"RapiGEN Inc.","country":"South Korea","website":"www.rapigen-inc.com\/eng"},"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":["SARS-CoV"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"BIOCREDIT COVID-19 Ag Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in human nasal specimen. This test is for in-vitro professional diagnostic use and intended as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms. It provides only an initial screening test result and more specific alternative diagnosis methods should be performed in order to confirm COVID-19 infection. BIOCREDIT COVID-19 Ag Test Nasal has been evaluated with clinical nasal specimens which were identified with teh RT-PCR test in Korea.","last_updated":"2022-10-17 12:59:05 CET","testList":[{"id_test":"5207","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"276000","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"0 of 400"},{"parameter":"False negatives","value":"7.8","unit":"%","info":"10 of 128"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.2","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"4086","commercial_name":"2019-nCoV Ag & FLU A\/B ComboRapid Test","manufacturer":{"id_manufacturer":"1302","name":"Reach Diagnostic (Wuhan) Biotech Co. 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protein"],"notes":"SARS-COV-2 Ag Rapid Test Cassette is listed by BfArM","last_updated":"2022-09-29 09:37:55 CET","testList":[{"id_test":"3894","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.6","unit":"%"},{"parameter":"False negatives","value":"1.2","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.2","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.8","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2298","commercial_name":"Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)","manufacturer":{"id_manufacturer":"1071","name":"Realy Tech","country":"China","website":"www.realytech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":null,"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasopharyngeal swab","Oropharyngeal 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"}],"target":[],"notes":"For more information please see the website","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1999","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"12.5","unit":"AU\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"209","unit":"AU"},{"parameter":"False negatives","value":"450","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":"(>99,9)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"3972","commercial_name":"Red Cell COVID-19 Self Test","manufacturer":{"id_manufacturer":"1445","name":"Red Cell Biyoteknoloji A.\u015e.","country":"Turkey","website":"www.redcell.com.tr"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Mid-turbinates swab","Nasal 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The Reszon COVID-19 Rapid Antigen Test (Nasal Swab) is intended for use by clinical laboratories or healthcare workers for point-of-care testing and home self-testing.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2644","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":"15","performances":[{"parameter":"LOD","value":"150","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"0 out of 140 negative samples"},{"parameter":"False negatives","value":"2.8","unit":"%","info":"3 out of 107 positive samples"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.27","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2601","commercial_name":"Salixium COVID-19 Rapid Antigen Test (Saliva\/Nasal Swab Samples)","manufacturer":{"id_manufacturer":"1174","name":"Reszon Diagnostics International Sdn. 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This study was conducted by 8 intended users at 4 near patient testing clinical sites. Patients above 14 years of age visiting the study sites seeking testing and presenting symptoms suggestive of upper respiratory infections consistent with COVID 19 or influenza were approached to participate in the study, and those beyond 7 days since the onset of symptoms were excluded. 2 nasopharyngeal swabs were collected from each study participant. In a randomized manner, 1 swab was tested immediately at the study site using the SARS CoV 2 & Flu A\/B Rapid Antigen Test, and the other was sent to a central laboratory for testing using a highly sensitive US FDA approved multiplex RT PCR method as the comparator. In total, 105 participants were enrolled in this study, and valid rapid antigen and RT PCR results were obtained for 104 participants.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2674","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"8.29","unit":"TCID50\/ml","info":"SARS-CoV-2"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.41","unit":"%","info":"SARS-CoV-2 (0.04%-7.60%)"},{"parameter":"False negatives","value":"15.15","unit":"%","info":"SARS-CoV-2 (5.11%-31.90%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"94.23","unit":"%","info":"SARS-CoV-2 Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"84.85","unit":"%","info":"SARS-CoV-2 Antigen"},{"parameter":"Clinical Specificity","value":"98.59","unit":"%","info":"SARS-CoV-2 Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"25547","commercial_name":"SARS-CoV-2 & Flu A\/B Rapid Antigen Test","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.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":["Nasopharyngeal swab"],"pathogen":["Influenza A","Influenza A H1N1","Influenza A H3N2","Influenza B","Influenza B Victoria","Influenza B Yamagata","SARS-CoV","SARS-CoV-2"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"last_updated":"2023-03-31 17:44:04 CET","testList":[{"id_test":"21050","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"8.29","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%","info":"refer to the LoD and analytical studies"},{"parameter":"Analytical Specificity","value":"100","unit":"%","info":"refer to the analytical studies"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"tests","info":"2 out of 310"},{"parameter":"False negatives","value":"20","unit":"tests","info":"20 out of 105"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"not applicable for rapid tests"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.24","unit":"%","info":"For ct \u2264 30"},{"parameter":"Clinical Specificity","value":"99.35","unit":"%"}]}]},{"id_device":"2323","commercial_name":"SARS-CoV-2 Antigen Self Test Nasal","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.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":[{"id_lineage":"1032","lineage_name":"B.1.351","lineage_country":"Beta"},{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"},{"id_lineage":"1323","lineage_name":"B.1.621","lineage_country":"Mu"}],"target":[],"notes":"The SARS-CoV-2 Antigen Self Test Nasal is technically identical to the nasopharyngeal test launched in 2020 (SARS-CoV-2 Rapid Antigen Test), which is already included in the EU common list of COVID-19 rapid antigen tests.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2024","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"146.6","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.38","unit":"%","info":"1 false positive out of 263 PCR negative samples."},{"parameter":"False negatives","value":"8.9","unit":"%","info":"9 false negative results out of 101 PCR positive samples for Ct<=30."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.3","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"91.1","unit":"%","info":" (Ct value \u2264 30)"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":" (overall cohort)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"25546","commercial_name":"SARS-CoV-2 Rapid Antigen Test 2.0 ","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.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"],"pathogen":["SARS-CoV","SARS-CoV-2"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"last_updated":"2023-03-31 17:45:26 CET","testList":[{"id_test":"21059","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"14.6","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%","info":"Refers to the LoD and analytical studies"},{"parameter":"Analytical Specificity","value":"100","unit":"%","info":"Refers to the analytical studies"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"tests","info":"1 out of 402"},{"parameter":"False negatives","value":"1","unit":"tests","info":"1 out of 100"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"Not applicable for rapid tests"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%","info":"Overall Ct values"},{"parameter":"Clinical Specificity","value":"99.75","unit":"%","info":"Overall Ct values"}]}]},{"id_device":"5839","commercial_name":"SARS-CoV-2 Rapid Antigen Test 2.0 Nasal","manufacturer":{"id_manufacturer":"854","name":"Roche (SD BIOSENSOR)","country":"Switzerland","website":"https:\/\/diagnostics.roche.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":["SARS-CoV","SARS-CoV-2"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"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":"1137","lineage_name":"B.1.429","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":null,"lineage_name":"B.1.526.1","lineage_country":""},{"id_lineage":null,"lineage_name":"B.1.526.2","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":null,"lineage_name":"Other","lineage_country":null},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"notes":"In addition to the validation studies listed in the Instructions for Use (IFU), this product was evaluated independently in a study conducted by investigators at the Technical University of Munich and the Institute of Virology at Helmholtz Munich. This  study  prospectively enrolled 428  healthcare  workers  from  the University Hospital Munich Rechts der Isar of the Technical University of Munich who either reported recent onset of COVID-19 associated symptoms or completed routine diagnostic testing between 24th of May and 22nd of September 2022. Rapid test performance was compared to the standard-of-care RT-PCR results at the hospital, which was also calibrated to report viral load in genomic copies (GE) \/ ml. All samples with a viral load above 9.5x104 GE\/ml were sequenced, and results revealed a majority of infections with BA.5 followed by BA.2 and BA.4. In the entire cohort, the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal demonstrated a sensitivity of 89.4% and a specificity of 99.4%. 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Conclusion: Minimal detection limits of COVID-19 Antigen Rapid Test is 100pg\/ml for recombine COVID-19 protein and 100TCID50\/mL for inactivated SARS-COV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1527","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Other","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU","info":"0"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.15","unit":"%","info":"2 on 93"},{"parameter":"False negatives","value":"0.96","unit":"%","info":"10 on 313"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%","info":"(95% CI*: 94.9%~98.5%)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"90.1","unit":"%","info":"(95% CI*:82.5%~95.1%)"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%","info":"(95% CI*: 97.7%~99.9%)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"3026","commercial_name":"Ultra COVID-19 Ag","manufacturer":{"id_manufacturer":"1345","name":"SD Biosensor Healthcare Private Limited","country":"India","website":"www.sdbiosensor.co.in"},"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 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CET","testList":[{"id_test":"21061","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"N.A.","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"53.2","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","unit":"samples"},{"parameter":"False negatives","unit":"samples"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"according to the precision test data"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"%"},{"parameter":"Clinical 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CET","testList":[{"id_test":"21062","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"14.6","unit":"TCID50\/ml","info":"NP swab"},{"parameter":"LOD","value":"13","unit":"TCID50\/ml","info":"NS swab"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"99","unit":"%","info":"NP Swab"},{"parameter":"Analytical Specificity","value":"99.75","unit":"%","info":"NP Swab"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"samples","info":"Negative Antigen: 401 out of 402 (NP)"},{"parameter":"False negatives","value":"1","unit":"samples","info":"Positive Antigen: 99 out of 100 (NP)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%","info":"according to the precision data"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%","info":"NP Swab"},{"parameter":"Clinical Sensitivity","value":"95.8","unit":"%","info":"NS swab"},{"parameter":"Clinical Specificity","value":"99.75","unit":"%","info":"NP Swab"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"NS swab"}]}]},{"id_device":"2052","commercial_name":"STANDARD Q COVID-19 Ag Test Nasal","manufacturer":{"id_manufacturer":"224","name":"SD BIOSENSOR Inc.","country":"South Korea","website":"http:\/\/sdbiosensor.com\/xe\/"},"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 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swab","Saliva"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"INTENDED USE The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARSCoV- 2 Antigen Rapid Test can also be used for testing specimens from asymptomatic individuals. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infec-tion. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of disease. Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARSCoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1572","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","notes":" SARS-CoV-2 antigen rapid test kit is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab or saliva specimens. ","performances":[{"parameter":"LOD","value":"160","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.1","unit":"%","info":"(95% CI: 93.1%-98.9%)"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%","info":"(95% CI: 98.2%-99.9%)"},{"parameter":"Type of antigen","info":"nucleocapsid"}]}]},{"id_device":"1818","commercial_name":"Senova Greenlight","manufacturer":{"id_manufacturer":"825","name":"Senova Gesellschaft f\u00c3\u00bcr Biowissenschaft und Technik","country":"Germany","website":"www.senova.de"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC","Semi-automated"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"The GreenLight SARS-CoV-2 antigen test is an in-vitro-diagnostic for the detection of SARS-CoV-2 antigen in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical or epidemiological criteria. GreenLight SARS-CoV-2 antigen test is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. Results must be interpreted together with clinical information i.e. symptoms, suspect of infection, clinical methods and other in-vitro diagnostic procedures. The product may be used in any medical laboratory or non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulations. The test provides primarily the test results and optional additional information compiled in a report sent to the smart-phone of the user or a smartphone within a work group.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1496","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Quantitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"12","performances":[{"parameter":"LOD","value":"502","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.9","unit":"%","info":"4 FP out of 102 PCR negatives"},{"parameter":"False negatives","value":"5.2","unit":"%","info":"2 negatives out of 38 PCR positives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90","unit":"%","info":"(CI95% :80.7 \u2013 99)"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":"(CI95%: 95.3 \u2013 100)"},{"parameter":"Type of antigen","info":"N Protein"}]}]},{"id_device":"2040","commercial_name":"Novel Coronavirus Neutralizing Antibody Rapid Test Kit","manufacturer":{"id_manufacturer":"940","name":"Sensing Self Pte. 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respiratory syndrome (MERS) coronavirus, Adenovirus, Enterovirus, Influenza A (H1N1 and H3N2) and B viruses, Avian influenza virus, Parainfluenza type 1-4, Measles virus, Human metapneumovirus, Mumps virus, Rhinovirus, Epstein-Barr virus, Respiratory syncytial virus, Staphylococcus aureus, Streptococcus pneumoniae, Staphylococcus epidermidis, Mycobacterium tuberculosis, Legionella pneumophila, Haemophilus influenza, Streptococcus pyogenes, Chlamydia pneumoniae, Mycoplasma pneumoniae, Candida albicans, organisms that make up normal respiratory flora, and organism(s) that causes parapertussis and pneumocystis.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1680","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"75","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.99","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"97.57","unit":"%"},{"parameter":"Clinical Specificity","value":"99.29","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2561","commercial_name":"SG Diagnostics COVID-19 Dual Immunity Rapid Test Kit (anti-Spike RBD IgG and anti-Nucleocapsid Protein Antibodies)","manufacturer":{"id_manufacturer":"921","name":"SG Diagnostics Pte 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POC"],"target_type":["IgG"],"specimen":["ACD plasma","Peripheral blood","Plasma","Venous whole blood","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[],"target":[],"notes":"Detects anti-Spike RBD IgG antibody","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2267","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"35","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"see Clinical Performance Data"},{"parameter":"False negatives","info":"see Clinical Performance Data"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.2","unit":"% 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POC"],"target_type":["Antigen"],"specimen":["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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Detected antigens are Spike protein and Nucleocapsid protein","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2268","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"50","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"see Clinical Performance Data"},{"parameter":"False negatives","info":"see Clinical Performance Data"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.18","unit":"%","info":" (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.75","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"96.37","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"2935","commercial_name":"InstaView COVID-19 Antigen","manufacturer":{"id_manufacturer":"1294","name":"SG Medical Inc.","country":"South Korea","website":"www.sgmedical.kr"},"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"],"pathogen":["SARS-CoV"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"1495","lineage_name":"P.1","lineage_country":"Gamma"}],"target":["nucleocapsid protein"],"notes":"None","last_updated":"2022-09-20 10:56:25 CET","testList":[{"id_test":"21064","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"N.A.","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.2","unit":"%"},{"parameter":"False negatives","value":"5","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.9","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2154","commercial_name":"Coronavirus Ag Rapid Test Cassette (Swab)","manufacturer":{"id_manufacturer":"999","name":"Shandong ThinkLab Biotechnology Co. 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Negative results don\u2019t preclude SARS-CoV-2 infection and they can not be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a donor screening test for SARS-CoV-2.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2282","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"False positive results will occur, especially when used where the prevalence of infection is low"},{"parameter":"False negatives","info":"False negative results can occur if the sample was taken incorrectly or if the virus below the LoD"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.81","unit":"%","info":"(Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"89.52","unit":"%","info":"(Antigen)"},{"parameter":"Clinical Specificity","value":"99.34","unit":"%","info":"(Antigen)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2155","commercial_name":"LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay)","manufacturer":{"id_manufacturer":"1000","name":"Shanghai Liangrun Biomedicine Technology Co. 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This kit uses colloidal gold immuno-lateral chromatography technology. Antigen detection is used for auxiliary diagnosis or epidemiological investigation of human infection with SARS-CoV-2.The test is for professional use only","last_updated":"2023-05-17 17:37:00 CET","testList":[{"id_test":"21063","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"326000","unit":"TCID50\/ml","info":"swab"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5.35","unit":"AU"},{"parameter":"False negatives","value":"0.7","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.46"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94.65","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2145","commercial_name":"SARS-CoV-2\uff08COVID-19\uff09Antigen Rapid Detection Kit (Lateral Flow Method)","manufacturer":{"id_manufacturer":"993","name":"Shen Zhen Zi Jian Biotechnology Co. 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Our company has successively won the honorary titles of \"Shenzhen high tech enterprise\" and \"national high tech enterprise\", ISO9000, ISO13485 quality management system certification and CE certification.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1626","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"45","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"7","unit":"%","info":"The probability of false positive is 7%."},{"parameter":"False negatives","value":"1.18","unit":"%","info":"The probability of false negative is 1.18%."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.5","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93","unit":"%"},{"parameter":"Clinical Specificity","value":"98.82","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2152","commercial_name":"SARS-CoV-2 Antigen Rapid Detection Kit","manufacturer":{"id_manufacturer":"997","name":"Shenzhen CAS-Envision Medical Technology Co. 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Package Insert (1 each) Instructions for use.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1671","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"22.5","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.17","unit":"%","info":"(2\/92)"},{"parameter":"False negatives","value":"0","unit":"%","info":"(0\/78)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"97.5","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1998","commercial_name":"COVID-19 IgM\/IgG Rapid Test Kit","manufacturer":{"id_manufacturer":"915","name":"Shenzhen Dakewe Bio-engineering Co. 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Package Insert (1 each) Instructions for use.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1675","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"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","value":"1.92","unit":"%","info":"(7\/364)"},{"parameter":"False negatives","value":"6.12","unit":"%","info":"(15\/245)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"93.9","unit":"%"},{"parameter":"Clinical Specificity","value":"98.1","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2415","commercial_name":"Sars-CoV-2 antigen test kit (colloidal gold)","manufacturer":{"id_manufacturer":"609","name":"Shenzhen Dymind Biotechnology Co. Ltd.","country":"China","website":"www.dymind.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","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"The SARS-CoV-2 Antigen Test Kit is a gold immuno-chromatographic assay (GICA) that is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab (NS) specimens directly from individuals who are suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient\u2019s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2117","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"150","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.59","unit":"%"},{"parameter":"False negatives","value":"2.65","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.58","unit":"%","info":" (91.48% -99.06%)"},{"parameter":"Clinical Specificity","value":"98.37","unit":"%","info":" (94.25% - 99.80%)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2418","commercial_name":"SARS-CoV-2 antigen test kit (Saliva sample)","manufacturer":{"id_manufacturer":"609","name":"Shenzhen Dymind Biotechnology Co. 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Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. 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Thank you very much for the update! Best regards, Anna Zhu","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1799","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"400","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"0 of 210 (100% specificity)"},{"parameter":"False negatives","value":"3.23","unit":"%","info":"5 of 155 (96.77% sensitivity)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.63","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.77","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleoprotein"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2989","commercial_name":"SARS-CoV-2 Antigen Rapid Test Kit (Immunofluorescence Assay)","manufacturer":{"id_manufacturer":"1322","name":"Shenzhen Lvshiyuan Biotechnology Co. 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Use only once. 4. Do not touch the reaction area of test strip. 5. Do not use test kit beyond the expiration date. 6. Do not use the kit if the pouch is punctured or sealed not well. 7. Testing should be applied by professionally trained staff working in certified laboratories or clinics. 8. The test result should be interpreted by the physician along with clinical findings and other laboratory test results. 9. 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Ltd.","country":"China","website":"http:\/\/www.zechengbio.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"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":""}],"target":[],"notes":"Antibody test, no antigen","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2354","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.3","info":"Test 153 negative samples, 2 results are postive;"},{"parameter":"False negatives","value":"3.63","info":"Test 55 postive samples, 2results are negative;"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"98.7","unit":"%"}]}]},{"id_device":"3066","commercial_name":"TARGETINGONE\u00ae SARS-CoV-2 Antigen Test","manufacturer":{"id_manufacturer":"1356","name":"TargetingOne Technology (Beijing) Corporation","country":"China","website":"http:\/\/www.targetingone.com\/en\/CompanyProfile\/index.aspx"},"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":["Anterior nasal swab"],"pathogen":["SARS-CoV"],"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":"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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"SARS-CoV-2 Antigen Test is used for in vitro qualitative detection of the SARS-CoV-2 N antigen in human nasal secretions. Antigen testing is generally conducted in the acute infection period, that is, within 7 days of the onset of symptoms. Positive results from the antigen test can be used for early triage and rapid management of patients with suspected infections. However, a positive result only indicates the presence of SARS-CoV-2 N antigen in the sample, and cannot be used as a basis for the diagnosis of SARS-CoV-2 infection. Negative results do not rule out SARS-CoV-2 infection and may not be used as the sole basis for treatment and disease management decisions. Further nucleic acid testing should be performed for both antigen positive and negative results in the suspected population. SARS-CoV-2 Antigen Test is used for latex immunochromatography for the detection of SARS-CoV-2 N antigen in human nasal secretions. The SARS-CoV-2 monoclonal antibody 2 is fixed in the detection zone (T line) of the nitrocellulose (NC) membrane,and a Goat anti-mouse polyclonal antibody is fixed in the quality control zone (C line) of the NC membrane. A mixture of SARS-CoV-2 monoclonal antibody 1 labeled with red latex was immobilized on a fiberglass membrane.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2772","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"field_variants_detected B.1.604","performances":[{"parameter":"LOD","value":"100","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.98","unit":"%"},{"parameter":"False negatives","value":"12.26","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.69","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"87.74","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"99.02","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2584","commercial_name":"INFO Covid-19 Ag Test","manufacturer":{"id_manufacturer":"1178","name":"T\u00c3\u00bcrklab Tibbi Mal. San. ve Tic. A.S.","country":"Turkey","website":null},"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":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"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":""}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2289","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","unit":"AU"},{"parameter":"False negatives","value":"43","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.14","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.71","unit":"%"},{"parameter":"Clinical Specificity","value":"99.54","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1753","commercial_name":"INFO SARS-CoV-2 IgM\/IgG Ab Test","manufacturer":{"id_manufacturer":"1178","name":"T\u00c3\u00bcrklab Tibbi Mal. San. ve Tic. A.S.","country":"Turkey","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"SARS-CoV-2 IgM\/IgG Antibody Test is a rapid immunochromatographic assay for qualitatively detection IgG and IgM antibodies of coronavirus disease in human serum, plasma or whole blood.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1431","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"U\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.17","unit":"% IgG"},{"parameter":"Accuracy","value":"93.33","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.88","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"87.54","unit":"% IgM"}]}]},{"id_device":"1751","commercial_name":"RAPIDAN TESTER Covid-19 Ag Test","manufacturer":{"id_manufacturer":"1178","name":"T\u00c3\u00bcrklab Tibbi Mal. San. ve Tic. A.S.","country":"Turkey","website":null},"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":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"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":""}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1429","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"30","unit":"U\/ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","unit":"AU"},{"parameter":"False negatives","value":"43","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.14","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.71","unit":"%"},{"parameter":"Clinical Specificity","value":"99.54","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1752","commercial_name":"RAPIDAN TESTER SARS-CoV-2 IgM\/IgG Ab Test","manufacturer":{"id_manufacturer":"1178","name":"T\u00c3\u00bcrklab Tibbi Mal. San. ve Tic. A.S.","country":"Turkey","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1430","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"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":"Accuracy","value":"96.17","unit":"% IgG"},{"parameter":"Accuracy","value":"93.33","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.88","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"87.54","unit":"% IgM"}]}]},{"id_device":"1689","commercial_name":"TEST IT Covid-19 Ag Test","manufacturer":{"id_manufacturer":"1178","name":"T\u00c3\u00bcrklab Tibbi Mal. San. ve Tic. A.S.","country":"Turkey","website":null},"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":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"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":""}],"target":["nucleocapsid protein"],"notes":"N\/A","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1368","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"30","unit":"AU"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","unit":"AU"},{"parameter":"False negatives","value":"43","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.14","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.71","unit":"%"},{"parameter":"Clinical Specificity","value":"99.54","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1722","commercial_name":"TOYO Covid-19 Ag Test","manufacturer":{"id_manufacturer":"1178","name":"T\u00c3\u00bcrklab Tibbi Mal. San. ve Tic. A.S.","country":"Turkey","website":null},"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":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"},{"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":""}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1402","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"5","unit":"AU"},{"parameter":"False negatives","value":"43","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.14","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"92.71","unit":"%"},{"parameter":"Clinical Specificity","value":"99.54","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2215","commercial_name":"Viraspec SARS-CoV-2 Antigen Rapid Test","manufacturer":{"id_manufacturer":"1030","name":"Thyrolytics AB","country":"Sweden","website":"www.thyrolytics.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":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":["nucleocapsid protein"],"notes":"NA","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1916","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"1000","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"(0 out of 162)"},{"parameter":"False negatives","value":"10","unit":"%","info":"(12 out of 120)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"95.7","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2054","commercial_name":"TODA Autotest Nasal Covid-19","manufacturer":{"id_manufacturer":"681","name":"TODA PHARMA","country":"France","website":"https:\/\/www.todapharma.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":["Anterior nasal swab","Nasal swab"],"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":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":""}],"target":["nucleocapsid protein"],"notes":"Please kindly note that the above mentioned performance rates are based on nasal swab.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1734","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.38","unit":"%","info":"On 59 negative samples confirmed by RT-PCR, 57 were also negative with our test : 2 false positives"},{"parameter":"False negatives","value":"0","unit":"%","info":"On 34 positive samples confirmed by RT-PCR, 34 were also negative with our test : 0 false negative"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"94","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1959","commercial_name":"Toda Coronadiag +","manufacturer":{"id_manufacturer":"681","name":"TODA PHARMA","country":"France","website":"https:\/\/www.todapharma.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":["Peripheral blood","Plasma","Serum","Venous whole blood","Whole blood","Whole blood with anti-coagulants"],"pathogen":[],"lineage":[],"target":[],"notes":"Please kindly note that the above mentioned performance rates are valid for IgG and IgM. Please kindly note that the performance rates are based on specimen which have been assessed between Day 14 and Day 19 after onset of symptoms.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1635","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"% IgG"},{"parameter":"Accuracy","value":"100","unit":"% IgM"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgG"},{"parameter":"Clinical Sensitivity","value":"100","unit":"% IgM"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgG"},{"parameter":"Clinical Specificity","value":"100","unit":"% IgM"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1913","commercial_name":"TODA Covdiag Saliva","manufacturer":{"id_manufacturer":"681","name":"TODA PHARMA","country":"France","website":"https:\/\/www.todapharma.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":["Saliva","Sputum"],"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":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":""}],"target":["nucleocapsid protein","spike protein"],"notes":"Please kindly note that the above mentioned performance rates were assessed on saliva specimens.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1590","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":"10","performances":[{"parameter":"LOD","value":"125","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.42","unit":"%","info":"On 236 negative samples confirmed by RT-PCR, 235 were also negative with our test : 1 false positive"},{"parameter":"False negatives","value":"7.1","unit":"%","info":"On 169 positive samples confirmed by RT-PCR,157 were also positive with our test: 12 false negatives"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"93.9","unit":"%"},{"parameter":"Clinical Specificity","value":"99.9","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1936","commercial_name":"Coronavirus (SARS-CoV 2) Ab IgG \/ IgM - Nucleocapsid (N protein)","manufacturer":{"id_manufacturer":"885","name":"Tody Laboratories Int.","country":"Romania","website":"www.todylaboratories.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antibody","IgG","IgM"],"specimen":["Peripheral blood","Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"Nucleocapsid (N) protein as target. IgG Limit of Detection (LoD): 1:40 (0.025) IgM Limit of Detection (LoD): 1:8 (0.125)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1612","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0.025","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3.7","unit":"%","info":"From studies performed by manufacturer, the false positive rate is 3.7% (specificity = 96.3%)"},{"parameter":"False negatives","value":"3.1","unit":"%","info":"From studies performed by manufacturer, the false negative rate is 3.1% (sensitivity = 96.9%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.9","unit":"%"},{"parameter":"Clinical Specificity","value":"96.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid (N protein)"}]}]},{"id_device":"1934","commercial_name":"Coronavirus (SARS-CoV 2) Antigen - Oral Fluid","manufacturer":{"id_manufacturer":"885","name":"Tody Laboratories Int.","country":"Romania","website":"www.todylaboratories.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Deep (cough) sputum","Saliva","Sputum"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"Minimum detection limit = 100 pg\/ml","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1610","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"From studies performed by manufacturer, the false positive rate is 0.7% (specificity = 99.3%)"},{"parameter":"False negatives","info":"From studies performed by manufacturer, the false negative rate is 9.9% (sensitivity = 90.1%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"90.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.3","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1935","commercial_name":"Coronavirus (SARS-CoV 2) Antigen - Swab Specimen","manufacturer":{"id_manufacturer":"885","name":"Tody Laboratories Int.","country":"Romania","website":"www.todylaboratories.com\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"notes":"Detection limit: 100 TCID50\/ml. Performance characteristics using the nasal swab specimen: Sensitivity: 92.9% Specificity: >99.9% Accuracy: 96.2% False positives (nasal swab specimen): From studies performed by manufacturer, the false positive rate is <0.1% (specificity = >99.9%) False negatives (nasal swab specimen): From studies performed by manufacturer, the false negative rate is 7.1% (sensitivity = 92.9%)","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1611","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"From studies performed by manufacturer, the false positive rate is 1.0% (specificity = 99.0%)"},{"parameter":"False negatives","value":"3.6","unit":"%","info":"From studies performed by manufacturer, the false negative rate is 3.6% (sensitivity = 96.4%)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.2","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.4","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid (N) protein"}]}]},{"id_device":"1933","commercial_name":"Coronavirus (SARS-CoV-2) Neutralizing Antibodies","manufacturer":{"id_manufacturer":"885","name":"Tody Laboratories Int.","country":"Romania","website":"www.todylaboratories.com\/"},"ce_marking":"Yes","commercial_status":"Unknown","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Other"],"target_type":["Antibody","IgG","IgM"],"specimen":["Peripheral blood","Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"Anti-Spike Protein, Colloidal Gold","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1609","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0.025","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.9","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"95.7","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"3152","commercial_name":"Uni-Gold SARS_CoV-2 Antigen Test","manufacturer":{"id_manufacturer":"1393","name":"Trinity Biotech plc","country":"Ireland","website":"www.trinitybiotech.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab"],"pathogen":[],"lineage":[{"id_lineage":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Please send any questions regarding clarifications to micheal.roche@trinitybiotech.com","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2860","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"10","notes":"antigen_epi Monoclonals are mouse IgM, one recognises the conformational epitope, the other the linear epitope","performances":[{"parameter":"LOD","value":"1.3","unit":"ml"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.05","unit":"%","info":"Prospective study: False positives 2\/189"},{"parameter":"False negatives","value":"1.07","unit":"%","info":"CT<32 = 1\/93"},{"parameter":"False negatives","value":"0","unit":"%","info":"CT<28 = 0\/77"},{"parameter":"Precision","info":"Not evaluated"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.9","unit":"%","info":"CT<32  92\/93 "},{"parameter":"Clinical Sensitivity","value":"100","unit":"%","info":"CT<28 = 77\/77"},{"parameter":"Clinical Specificity","value":"98.9","unit":"%","info":"187\/189 - Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2523","commercial_name":"Unibioscience Covid-19 Nasopharynx Antigen Test","manufacturer":{"id_manufacturer":"1150","name":"Unibioscience AS","country":"Turkey","website":"www.unibioscience.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","Nasopharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"The SARS CoV-2 Antigen Rapid Test is a lateral flow immunoassay for the rapid qualitative detection of the N-protein antigen of SARS CoV-2 in swab specimens from both symptomatic and asymptomatic COVID- 19 infected individuals.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2227","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"2870","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.42","unit":"%","info":"5\/350"},{"parameter":"False negatives","value":"0.85","unit":"%","info":"3\/350"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.86","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.57","unit":"%"},{"parameter":"Clinical Specificity","value":"99.14","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2521","commercial_name":"Vaxxitest 2019-nCoV Neutralizing Antibody Test","manufacturer":{"id_manufacturer":"1150","name":"Unibioscience AS","country":"Turkey","website":"www.unibioscience.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antibody","IgG","IgM"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":[],"notes":"MAIN COMPONENTS of Vaxxitest\u2122 Reagent: composed of test strips, plastic parts (box), buffer, and dropper; Test Strip main components: 1. Recombinant protein ACE-2 (fixed in the nitrocellulose membrane detection area), Goat anti-rabbit lgG polyclonal antibody (fixed on nitrocellulose membrane quality control area). 2. Colloidal gold-labelled novel coronavirus protein RBD (located on polyester cellulose membrane); colloidal gold-labelled rabbit lgG. Buffer: mainly composed of disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride. Colorimetric Card Additional preparation for testing: specimen collection containers and timer.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2225","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"20","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"6","unit":"%"},{"parameter":"False negatives","value":"2","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.24","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.98","unit":"%"},{"parameter":"Clinical Specificity","value":"94.74","unit":"%"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"2131","commercial_name":"OnSight\u2122 - COVID-19 Antigen Test","manufacturer":{"id_manufacturer":"988","name":"Unimed International Inc.","country":"United States","website":"www.unimed.net"},"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","Nasopharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"LOD: 1.26 x 102 TCID50\/mL","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1821","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":"15","performances":[{"parameter":"LOD","value":"126","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.6","unit":"%"},{"parameter":"False negatives","value":"3.9","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.4","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.1","unit":"%"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2133","commercial_name":"OnSight\u2122 - COVID-19 IgG\/IgM Combo Test","manufacturer":{"id_manufacturer":"988","name":"Unimed International Inc.","country":"United States","website":"www.unimed.net"},"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":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"Digital result reading with a Reader,","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1823","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"0","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"N.A."},{"parameter":"False negatives","info":"N.A."},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"96.8","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.3","unit":"%"},{"parameter":"Clinical Specificity","value":"99.8","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2135","commercial_name":"OnSight\u2122- COVID-19 NAb Quantitative Test","manufacturer":{"id_manufacturer":"988","name":"Unimed International Inc.","country":"United States","website":"www.unimed.net"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Near POC \/ POC"],"target_type":["IgG"],"specimen":["Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[{"id_lineage":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"}],"target":[],"notes":"OnSight\u2122- COVID-19 NAb Quantitative Test is an in vitro Rapid \u201cSandwich\u201d immunochromatography test for the \u201cQuantitative\u201d detection of circulating functional Neutralizing Antibodies (NAb) Titer post COVID-19 Vaccination or after SARS-CoV-2 Infection using a Reader. OnSight\u2122 - COVID-19 NAb Quantitative Test is a Point-Of-Care finger-prick whole blood Quantitative test for checking the efficacy of COVID-19 vaccines and monitoring the levels of NAb Titer longitudinally to help determine duration of immunity. OnSight\u2122- COVID-19 NAb Quantitative Test uses Receptor Binding Domain (RBD) of the viral Spike Protein (S), and it detects Neutralizing Antibodies (NAb) that neutralize the RBD-ACE2 interaction. RBD is the major neutralizing determinant for SARS-CoV-2. Clinical study has shown that serum IgG against RBD best correlates with virus-neutralizing activity and disease severity (https:\/\/www.jimmunol.org\/content\/206\/10\/2393) OnSight\u2122- COVID-19 NAb Quantitative Test has been standardized against \u201cFirst WHO International Standard for anti-SARS-CoV-2 Immunoglobulins\u201d (NIBSC Code: 20\/136) with excellent Correlation Coefficient (R2 = 0.99). Limit of Detection (LOD): 25 \u2013 50 BAU\/ml (Test Lot dependent).","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1825","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","unit":"AU","info":"0"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.97","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.17","unit":"%"},{"parameter":"Clinical Specificity","value":"98.67","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2249","commercial_name":"COVID-19 ANTIGEN RAPID TEST NASAL","manufacturer":{"id_manufacturer":"1047","name":"Unioninvest Ltd.","country":"Turkey","website":"www.unibioscience.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab"],"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":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Validation of the Unibioscience SARS CoV-2 Antigen Rapid Nasal Test was performed in correlation with the respective Ct values of the positive PCR samples, including clinical data on the duration of disease symptoms. Validation tests of PCR samples from symptomatic individuals with symptom onset before 5 days (N=400) resulted in a sensitivity of 99.00% (95% CI: 97.46%-99.73%) with a mean Ct value of 26.17 (Min 17.2 - Max 39.4). From the validation tests of PCR samples with a Ct value < 30 (N=250), a mean Ct value of 22.30 (Min 17.20-Max 29.90) resulted in a sensitivity of 99.60% (95% CI: 97.79%-99.9%). From the validation tests of PCR samples with a Ct value \u2265 30 (N=150), a mean Ct value of 32.60 (Min 30.1-Max 39.4) resulted in a sensitivity of 98.00% (95% CI: 94.27%-99.59%) The PCR test used in the validations was real-time PCR. The EasyprepFast real-time PCR kit was used. SARS-Cov-2 was the target genome. The corresponding target gene was the N1 and the E gene with the following primers: SARS-CoV-2_IBS_N1 \/ SARS-CoV-2_IBS_E2For the internal positive control (IPC), a GAPDH primer set was used. FAM, HEX and Cy5 dyes were applied for staining.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1950","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich, Double","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"7.57","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.25","unit":"%","info":"1\/400"},{"parameter":"False negatives","value":"1","unit":"%","info":"4\/400"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","info":" (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"99","unit":"%","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1874","commercial_name":"2019- nCoV and Flu A\/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay)","manufacturer":{"id_manufacturer":"860","name":"Ustar Biotechnologies (Hangzhou) Ltd.","country":"China","website":"en.bioustar.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":["Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"The 2019- nCoV and Flu A\/B Antigen Combo Rapid Test is used for in vitro qualitative detection of the nucleoprotein antigen of influenza A, influenza B and Novel Coronavirus (2019- nCoV) in samples from human oropharyngeal swabs, nasopharyngeal swabs and saliva.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1555","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"960","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","info":"NA"},{"parameter":"False negatives","info":"NA"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.94","unit":"%","info":"(96.12%-99.05%\uff09"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.65","unit":"%","info":"(91.25%-98.23%)"},{"parameter":"Clinical Specificity","value":"99.27","unit":"%","info":"(97.40%-99.91%)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2041","commercial_name":"Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit (Immunochromatography)","manufacturer":{"id_manufacturer":"941","name":"Vacure Prelab Medical Technology Co. Ltd.","country":"China","website":null},"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","Nasopharyngeal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[{"id_lineage":"1320","lineage_name":"B.1.617.1","lineage_country":"Kappa"}],"target":[],"notes":"CE registration number: RPS\/921\/2021 CE registration date: 04\/05\/2021 CE registration area: Spanish AUTHORIZED REPRESENTATITVE IN THE EUROPEAN COMMUNITY: CMC Medical Devices & Drugs S.L","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1719","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"1000","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.53","unit":"%"},{"parameter":"False negatives","value":"1.68","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"100","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"1831","commercial_name":"Coronavirus Ag Rapid Test Cassette (Swab)","manufacturer":{"id_manufacturer":"836","name":"Van Oostveen Medical B.V.","country":"Netherlands","website":"www.romed.nl\/en"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"pathogen":[],"lineage":[],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1509","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"115","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.34","unit":"%","info":"3 false positives \/ 874 true negative (sum of nasopharyngeal and nasal swab samples)"},{"parameter":"False negatives","value":"2.19","unit":"%","info":"5 false negatives \/ 228 true positive (sum of nasopharyngeal and nasal swab samples)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.42","unit":"%","info":"99.42 (antigen-nasopharyngeal), 98.73 (antigen-nasal)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.32","unit":"%","info":"98.32 (antigen-nasopharyngeal), 97.25 (antigen-nasal)"},{"parameter":"Clinical Specificity","value":"99.6","unit":"%","info":"99.60 (antigen-nasopharyngeal), 100 (antigen-nasal)"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2508","commercial_name":"KnowNow SARS-CoV-2 Rapid Antigen Test","manufacturer":{"id_manufacturer":"1145","name":"Vatic Health Ltd.","country":"United Kingdom","website":"https:\/\/www.knownow.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":["Saliva"],"pathogen":[],"lineage":[{"id_lineage":"689","lineage_name":"B.1.1.7","lineage_country":"Alpha"}],"target":[],"notes":"https:\/\/aic.mhra.gov.uk\/era\/pdr.nsf\/vwLkupFileRef\/11903?opendocument","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2212","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":null,"method":"Immunochromatography","measurement":null,"subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"500","unit":"PFU\/mL"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":" (Diagnostic Specificity 100% (95% CI 98.6-100%)). Reference Standard RT-PCR"},{"parameter":"False negatives","value":"4.4","unit":"%","info":" (Diagnostic Sensitivity 95.6% (95% CI 91.1-98.2%). Reference standard was RT-PCR"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":" (Antigen)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"95.6","info":" (Antigen)"},{"parameter":"Clinical Specificity","value":"100","info":" (Antigen)"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"1956","commercial_name":"COVID19-CHECK1 ANTIGEN","manufacturer":{"id_manufacturer":"574","name":"VEDALAB","country":"France","website":"www.vedalab.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab"],"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":"1321","lineage_name":"B.1.617.2","lineage_country":"Delta"},{"id_lineage":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"Professional version is also CE marked and available","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1632","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":null,"subcategory":null,"time_minutes":"20","performances":[{"parameter":"LOD","value":"0.05","unit":"ng\/mL","info":"recombinant nucleoprotein"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.33","unit":"%","info":"specificity 99.67%"},{"parameter":"False negatives","value":"0.92","unit":"%","info":"sensitivity 99.08% (Ct value <=25)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.51","unit":"%","info":"95% IC [98.14 - 100.00] (overall agreement)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99.08","unit":"%","info":"95% IC [94.67 - 100.00] for Ct<=25 (109 tested samples)"},{"parameter":"Clinical Specificity","value":"99.67","unit":"%","info":"95% IC [98.03 - 100.00] (300 tested samples)"},{"parameter":"Type of antigen","info":"Nucleoprotein"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2334","commercial_name":"Rapid-VIDITEST anti- SARS-CoV-2 (RBD) IgG","manufacturer":{"id_manufacturer":"951","name":"VIDIA spol. s r.o.","country":"Czechia","website":"https:\/\/www.vidia.cz"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["IgG"],"specimen":["Peripheral blood","Plasma","Serum","Whole blood"],"pathogen":[],"lineage":[],"target":["Other"],"notes":"Detection limit 1:640","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2035","assay_category":"Immuno-Antibody","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Neutralization Antibody (NAb)","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"0"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"3","unit":"%"},{"parameter":"False 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2500","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2037","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"1","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"AU"},{"parameter":"False negatives","value":"5","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.1","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.3","unit":"%"},{"parameter":"Clinical Specificity","value":"98.6","unit":"%"},{"parameter":"Type of antigen","info":"Other"}]}]},{"id_device":"2073","commercial_name":"Rapid-VIDITEST SARS-CoV-2 Antigen","manufacturer":{"id_manufacturer":"951","name":"VIDIA spol. s r.o.","country":"Czechia","website":"https:\/\/www.vidia.cz"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"1224","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":""}],"target":[],"notes":"LOD = 100pg\/ml or 1,16 x 10^2 TCID 50\/ml OD-475 Rapid-VIDITEST SARS-CoV-2 - Nasal and Nasopharyngeal swab OD-485 Rapid-VIDITEST SARS-CoV-2 - Oropharyngeal swab","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1755","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2061","commercial_name":"SARS-CoV-2 Antigen ","manufacturer":{"id_manufacturer":"951","name":"VIDIA spol. s r.o.","country":"Czechia","website":"https:\/\/www.vidia.cz"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"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":"3939","lineage_name":"B.1.616","lineage_country":""},{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""}],"target":[],"notes":"LOD = 100pg\/ml or 1,16 x 10^2 TCID 50\/ml","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1741","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Capture","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.42","unit":"%"},{"parameter":"False negatives","value":"1","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2998","commercial_name":"Covid-19 Antigen 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CET","testList":[{"id_test":"2704","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"N.A.","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"250","info":"pg\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"%","info":"98 percent sensitivity"},{"parameter":"False negatives","value":"2","unit":"%","info":"98 percent specificity"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3000","commercial_name":"SARS-CoV-2 Ag Rapid Test","manufacturer":{"id_manufacturer":"1326","name":"VIMEK BIOCONCEPT PVT Ltd.","country":"India","website":"https:\/\/www.vimekbioconcept.in\/"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual"],"target_type":["Antigen"],"specimen":["Nasopharyngeal swab"],"pathogen":["SARS-CoV"],"lineage":[],"target":["nucleocapsid protein"],"notes":"The Covid-19 Antigen test strip is coated with goat anti mouse IgG antibodies at control region and anti- SARS CoV-2 antibodies at test region on the membrane and colloidal gold conjugated with antiSARS CoV-2 antibodies and mouse IgG","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2706","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"N.A.","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"250","info":"pg\/mL"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"%","info":"98 percent sensitivity"},{"parameter":"False negatives","value":"2","unit":"%","info":"98 percent specificity"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"98","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2650","commercial_name":"Vision Biyoteknoloji Ara\u015ft\u0131rma Geli\u015ftirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited \u015eirketi","manufacturer":{"id_manufacturer":"1211","name":"Vision Biotechnology","country":"Turkey","website":"www.visionbiotechnology.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"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"}],"target":["nucleocapsid protein"],"notes":"This kit is used for the in vitro 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Twin test of this product evaluated and approved by Therapeutic Goods Administration (TGA) in Australia in 2022. \r\n4.The LOD for this product is 50 TCID50\/mL.","last_updated":"2022-09-30 09:55:16 CET","testList":[{"id_test":"3915","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (Nasopharyngeal Swab)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (Nasopharyngeal Swab)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2180","commercial_name":"RapidFor SARS-CoV-2 Rapid Antigen Test","manufacturer":{"id_manufacturer":"1016","name":"Vitrosens Biotechnology Co. 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Moreover, it is currently in use in Germany, Portugal, Czechia, Slovenia, Estonia, Sweden and Luxembourg.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1881","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"100","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1","unit":"%","info":"(91 out of 100)"},{"parameter":"False negatives","value":"3","unit":"%","info":"(3 out of 100)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97","unit":"%"},{"parameter":"Clinical Specificity","value":"99","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"3126","commercial_name":"RapidFor SARS-CoV-2 Rapid Antigen Test (FIA)","manufacturer":{"id_manufacturer":"1016","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-09-29 09:43:02 CET","testList":[{"id_test":"20283","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"-","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"%","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False positives","value":"0.79","unit":"%","info":"3 out of 379 (NP Swab for InfB)"},{"parameter":"False positives","value":"0.53","unit":"%","info":"2 out of 375 (NP Swab for InfA)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"3.03","unit":"%","info":"5 out of 165 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.56","unit":"%","info":"4 out of 156 (NP Swab for InfA)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.53","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Accuracy","value":"98.87","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.44","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"96.97","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.21","unit":"%","info":"NP swab:(Inf B)"}]}]},{"id_device":"4063","commercial_name":"RapidFor\u2122 SARS-CoV-2 & FLU A\/B Rapid Antigen Test","manufacturer":{"id_manufacturer":"678","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-11-17 10:04:42 CET","testList":[{"id_test":"5331","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"()","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False positives","value":"0.53","unit":"%","info":"2 out of 375 (NP Swab for InfA)"},{"parameter":"False positives","value":"0.79","unit":"%","info":"3 out of 379 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"3.03","unit":"%","info":"5 out of 165 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.56","unit":"%","info":"4 out of 156 (NP Swab for InfA)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Accuracy","value":"98.53","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Accuracy","value":"98.87","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"97.44","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Sensitivity","value":"96.97","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Specificity","value":"99.21","unit":"%","info":"NP swab:(Inf B)"}]}]},{"id_device":"5804","commercial_name":"RapidFor\u2122 SARS-CoV-2 + FLU A\/B + RSV Combo Test Kit","manufacturer":{"id_manufacturer":"678","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-12-22 08:49:09 CET","testList":[{"id_test":"20282","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"-","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"%","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False positives","value":"0.87","unit":"%","info":"2 out of 231(NP Swab for RSV)"},{"parameter":"False positives","value":"0.79","unit":"%","info":"3 out of 379 (NP Swab for InfB)"},{"parameter":"False positives","value":"0.53","unit":"%","info":"2 out of 375 (NP Swab for InfA)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"2.24","unit":"%","info":"5 out of 223 (NP Swab for RSV)"},{"parameter":"False negatives","value":"3.03","unit":"%","info":"5 out of 165 (NP Swab for InfB)"},{"parameter":"False negatives","value":"2.56","unit":"%","info":"4 out of 156 (NP Swab for InfA)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Accuracy","value":"98.87","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Accuracy","value":"98.53","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Accuracy","value":"98.46","unit":"%","info":"NP swab:(RSV)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"97.44","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Sensitivity","value":"96.97","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Sensitivity","value":"97.76","unit":"%","info":"NP swab:(RSV)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.47","unit":"%","info":"NP swab:(Inf A)"},{"parameter":"Clinical Specificity","value":"99.21","unit":"%","info":"NP swab:(Inf B)"},{"parameter":"Clinical Specificity","value":"99.13","unit":"%","info":"NP swab:(RSV)"}]}]},{"id_device":"5810","commercial_name":"RapidFor\u2122 SARS-CoV-2+RSV  Combo Test Kit","manufacturer":{"id_manufacturer":"678","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022 for SARS-CoV-2. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2023-01-09 10:03:07 CET","testList":[{"id_test":"5413","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"-","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"%","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analytical Sensitivity","value":"100","unit":"%"},{"parameter":"Analytical Specificity","value":"100","unit":"%"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (NP Swab for SARS-CoV-2)"},{"parameter":"False negatives","value":"0.87","unit":"%","info":"2 out of 231(NP Swab for RSV)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Accuracy","value":"98.46","unit":"%","info":"NP swab:(RSV)"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Sensitivity","value":"97.76","unit":"%","info":"NP swab:(RSV)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.13","unit":"%","info":"NP swab:(RSV)"}]}]},{"id_device":"3118","commercial_name":"RAPIDNEXT SARS-CoV-2 Rapid Antigen Test","manufacturer":{"id_manufacturer":"1016","name":"Vitrosens Biotechnology Co. Ltd.","country":"Turkey","website":"www.vitrosens.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Lab-based","Manual"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab","Nasopharyngeal swab","Oropharyngeal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"The LOD for this product is 50 TCID50\/mL","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2825","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"performances Omicron - Sensitivity (%98,25), Specificity (%100)","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"50 TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.6","unit":"%","info":"3 out of 498 - Nasopharyngeal swab"},{"parameter":"False negatives","value":"1.15","unit":"%","info":"6 out of 523 - Nasopharyngeal swab"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.1","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98.85","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Clinical Specificity","value":"99.4","unit":"%","info":"Nasopharyngeal swab"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"4058","commercial_name":"RAPIDNEXT\u2122 SARS-CoV-2 Rapid Antigen Test Kit","manufacturer":{"id_manufacturer":"678","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia in 2022. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-09-29 09:41:53 CET","testList":[{"id_test":"5313","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"()","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (Nasopharyngeal Swab)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (Nasopharyngeal Swab)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"}]}]},{"id_device":"2992","commercial_name":"RapidSens SARS-CoV-2 Rapid Antigen Test","manufacturer":{"id_manufacturer":"1016","name":"Vitrosens Biotechnology Co. 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Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021 and Therapeutic Goods Administration (TGA) in Australia at 2022. \r\n\r\n2.The LOD for this product is 50 TCID50\/mL.\r\n","last_updated":"2022-09-29 09:42:19 CET","testList":[{"id_test":"5314","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colorimetry","subcategory":"()","time_minutes":"15","performances":[{"parameter":"LOD","value":"50","unit":"TCID50\/ml","info":"for SARS-CoV-2"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0.95","unit":"%","info":"5 out of 525 (Nasopharyngeal Swab)"},{"parameter":"False negatives","value":"2.7","unit":"%","info":"17 out of 630 (Nasopharyngeal Swab)"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.09","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"97.3","unit":"%","info":"NP swab:(SARS-CoV-2)"},{"parameter":"Clinical Specificity","value":"99.05","unit":"%","info":"NP swab:(SARS-CoV-2)"}]}]},{"id_device":"3133","commercial_name":"RAPID GOLD PRO CoV-2 AG Test","manufacturer":{"id_manufacturer":"175","name":"VivaChek Biotech (Hangzhou) Co. 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protein"}]}]},{"id_device":"1914","commercial_name":"Zekmed antigen rapid test cassette (colloidal gold)","manufacturer":{"id_manufacturer":"874","name":"Zekmed","country":"Switzerland","website":"www.zekmed.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab","Saliva"],"pathogen":[],"lineage":[],"target":[],"notes":"authorized distributor , Hotzone solutions group .","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"1591","assay_category":"Immuno-Antigen","rapid_diagnostic":null,"self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":null,"detection_principle":"Colorimetry","subcategory":null,"time_minutes":"10","performances":[{"parameter":"LOD","value":"220000","unit":"AU"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"none according to cross reactivity report"},{"parameter":"False negatives","value":"0","unit":"%","info":"none according to cross reactivity report"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99","unit":"%"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"99","unit":"%"},{"parameter":"Clinical Specificity","value":"100","unit":"%"},{"parameter":"Type of antigen","info":"Nucleoprotein"}]}]},{"id_device":"2837","commercial_name":"LUNA AG - Hybrid Antigen Test Kit","manufacturer":{"id_manufacturer":"1265","name":"ZEKMED Ltd.","country":"United Kingdom","website":"https:\/\/zekmed.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Anterior nasal swab","Nasal swab","Oropharyngeal swab"],"pathogen":[],"lineage":[],"target":[],"notes":"Aditional documentation is available upon request.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2542","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":"15","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%","info":"none according to cross reactivity report"},{"parameter":"False negatives","value":"0","unit":"%","info":"none according to cross reactivity report"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.35","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Spike protein"}]}]},{"id_device":"2943","commercial_name":"ZEKMED CALLISTO Ag Antigen Rapid Test Kit","manufacturer":{"id_manufacturer":"1265","name":"ZEKMED Ltd.","country":"United Kingdom","website":"https:\/\/zekmed.com"},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal 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protein"],"notes":"There was 7 antigen test results that were inconsistent with PCR, these samples were re-tested with a third-party real-time PCR kit, of which 3 samples were consistent with the ZEMED Callisto antigen test kit, and 4 samples were consistent with the original results.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2649","assay_category":"Immuno-Antibody","rapid_diagnostic":null,"self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"4","unit":"AU"},{"parameter":"False 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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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"},{"id_lineage":"3939","lineage_name":"B.1.616","lineage_country":""},{"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":"20","lineage_name":"A.23.1","lineage_country":""},{"id_lineage":"2041","lineage_name":"C.37","lineage_country":"Lambda"},{"id_lineage":"1439","lineage_name":"C.36","lineage_country":""},{"id_lineage":"70","lineage_name":"AT.1","lineage_country":""},{"id_lineage":"1224","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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":[],"notes":"Accuracy: (98+210)\/ (98+0+2+210) *100%=99.35% (95%CI* 97.58% to 99.43%) Pe= (100*98+210*212)\/ (310*310) =0.557 Kappa:( P0 - Pe)\/(1-pe) =0.992","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2547","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2","unit":"AU"},{"parameter":"False negatives","value":"0","unit":"AU"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.35","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical 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protein"],"notes":"The SARS-CoV-2 virus has the characteristics of strong nucleocapsid (N) protein stability. The mutant virus strains that have been found worldwide are derived from the SARS-CoV-2 20B\/GR evolutionary strain (lineage B.1.1.7), including many mutation, the mutation location is the spike (S) protein of the new coronavirus, which is the location where the SARS-CoV-2 virus uses to bind to the cell's ACE2 receptor. The ZEKMED LUNA Ag Antigen Rapid Test Kit (N) produced by ZEKMED Ltd, is used for in vitro qualitative detection of SARS-CoV-2 virus nucleocapsid (N) protein in human nasopharyngeal , oropharyngeal , anterior -nasal or saliva samples. It can be seen that the mutation sites of mutated virus strains including Omicron strain have no effect on the detection rate of the kits produced by our company. The kit is suitable for assay of the SARS-CoV-2 variant virus called 'Omicron '.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2559","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","notes":"Legionella pneumophila, Streptococcus pneumonia, Streptococcus pyrogens, Human etapneumovirus (hMPV) 3 Type B1","performances":[{"parameter":"LOD","value":"400","unit":"TCID50\/ml"},{"parameter":"Calibration","info":"Evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"0","unit":"%"},{"parameter":"False negatives","value":"0","unit":"%"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"99.35","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"98","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"100","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"3515","commercial_name":"SOFTEC Covid-19 Antigen Test Kit","manufacturer":{"id_manufacturer":"1419","name":"ZET medical textile foreign trade Co LTD","country":"Turkey","website":"https:\/\/www.zetmedikal.com\/en"},"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","Nasopharyngeal swab"],"pathogen":["SARS-CoV"],"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":"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"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"},{"id_lineage":"1519","lineage_name":"P.3","lineage_country":"Theta"}],"target":["nucleocapsid protein"],"last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"3234","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"Yes","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"Membrane-based","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[]}]},{"id_device":"2226","commercial_name":"SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT","manufacturer":{"id_manufacturer":"1034","name":"ZET medikal tekstil dis tic Ltd. sti","country":"Turkey","website":"www.zetmedikal.com\/en"},"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":["Influenza A H1N1"],"lineage":[{"id_lineage":"20","lineage_name":"A.23.1","lineage_country":""},{"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":"3939","lineage_name":"B.1.616","lineage_country":""},{"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"},{"id_lineage":"1518","lineage_name":"P.2","lineage_country":"Zeta"}],"target":["nucleocapsid protein"],"notes":"Intended Use:The SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT is an immunochromatographic test kit, which contains specific antibodies for qualitative detection of (Covid-19) SARS COV-2 antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. The SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT  can be used in symptomatic and asymptomatic people for lay users.","last_updated":"2022-09-30 09:55:48 CET","testList":[{"id_test":"5467","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":"No","reader_required":"No","method":"Immunochromatography","measurement":"Qualitative","subclass":"N.A.","detection_principle":"Colloidal gold","subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"2300","unit":"AU"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"2.27","unit":"%","info":"3\/132"},{"parameter":"False negatives","value":"0.4","unit":"%","info":"1\/248"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"98.6","unit":"%"},{"parameter":"Reproducibility","info":"Not evaluated"},{"parameter":"Robustness","info":"Not evaluated"},{"parameter":"Clinical Sensitivity","value":"97.7","unit":"%"},{"parameter":"Clinical Specificity","value":"99.5","unit":"%"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"2780","commercial_name":"Pluridiag SARS-COV-2 Ag Rapid Test","manufacturer":{"id_manufacturer":"1248","name":"Zhejiang Aibu Biotech Co. Ltd.","country":"China","website":null},"ce_marking":"Yes","commercial_status":"Commercialised","hsc_common_list":"No","hsc_mutual_recognition":"No","physical_support":null,"format":["Manual","Near POC \/ POC"],"target_type":["Antigen"],"specimen":["Nasal swab"],"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":"1132","lineage_name":"B.1.427","lineage_country":"Epsilon"},{"id_lineage":"1137","lineage_name":"B.1.429","lineage_country":"Epsilon"},{"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":"678","lineage_name":"B.1.1.529","lineage_country":"Omicron"}],"target":["nucleocapsid protein"],"notes":"PluridiagTM SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen[1]. The test is for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing[3].It provides only an initial screening test result. More specific alternative diagnosis methods (molecular diagnostic and \/ or CT) should be performed in order to obtain the confirmation of SARS-CoV-2 infection. Not for at-home testing.","last_updated":"2022-08-24 09:08:01 CET","testList":[{"id_test":"2485","assay_category":"Immuno-Antigen","rapid_diagnostic":"Yes","self_test":null,"reader_required":"Yes","method":"Immunochromatography","measurement":"Quantitative","subclass":"Sandwich","detection_principle":null,"subcategory":null,"time_minutes":"15","performances":[{"parameter":"LOD","value":"75.5","unit":"AU"},{"parameter":"Calibration","info":"Not evaluated"},{"parameter":"Analysis of cross reactivity","info":"Evaluated"},{"parameter":"False positives","value":"1.28"},{"parameter":"False negatives","value":"3.9"},{"parameter":"Precision","info":"Evaluated"},{"parameter":"Accuracy","value":"97.86","unit":"%","info":"Antigen"},{"parameter":"Reproducibility","info":"Evaluated"},{"parameter":"Robustness","info":"Evaluated"},{"parameter":"Clinical Sensitivity","value":"96.1","unit":"%","info":"Antigen"},{"parameter":"Clinical Specificity","value":"98.72","unit":"%","info":"Antigen"},{"parameter":"Type of antigen","info":"Nucleocapsid protein"}]}]},{"id_device":"1842","commercial_name":"AndLucky SARS-CoV-2 Antigen Anterior Nasal Rapid Test (minimal invasive)","manufacturer":{"id_manufacturer":"624","name":"Zhejiang Anji Saianfu Biotech Co. 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