2026-06-13 11:14:15 CET2807Coronavirus (2019-nCoV)-Antigentest328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swab689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1GammaThe 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.2022-10-17 11:54:37 CET5303Immuno-AntigenYesNoNoImmunochromatographyQuantitativeSandwich15LOD79.2TCID50/mlLimit of detection is 5*10^1.2TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.11%The 269 negative samples, 3 of them is false positives.False negatives3.05%The 131 positive samples, 4 of them should is false negativesPrecisionEvaluatedAccuracy98.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.95%AntigenClinical Specificity98.88%Antigen)Type of antigenNucleocapsid protein519Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold)328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2022-08-24 09:08:01 CET437Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15521Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology)328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2022-08-24 09:08:01 CET451Immuno-AntibodyYesYesImmunoassayQualitative15Rapid diagnostic test card 2808Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnYesCommercialisedNoNoNear POC / POCAntibodyPeripheral bloodSerumVenous whole bloodWhole blood with anti-coagulants689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37LambdaThere are acolorimetric cards in the product, and the user can judge the semi-quantitative result based on the colorimetric card.2022-08-24 09:08:01 CET2513Immuno-AntibodyYesNoImmunochromatographySemiquantitativeSandwichColloidal gold15LOD0.25AUThe cut off Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies in serum samples detected by this kit was determined to be 0.250(OCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.69%869 samples have 6 false positivesFalse negatives1.47%339 samples have 5 false negativesPrecisionEvaluatedAccuracy99.09% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53% IgGClinical Specificity99.31% IgG1870Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swabThroat swabSARS-CoV-2678B.1.1.529Omicron689B.1.1.7Alpha1032B.1.351Beta1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu2041C.37Lambda1495P.1Gammanucleocapsid proteinThis 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.2022-09-20 14:48:19 CET3834Immuno-AntigenYesNoNoImmunochromatographyQualitativeSandwichColloidal gold15LOD396.22TCID50/mlCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives3.38%False negatives0.24%PrecisionEvaluatedAccuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.62%Clinical Specificity99.76%Type of antigenNucleocapsid protein2841Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)1069Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cnYesCommercialisedNoNoNear POC / POCAntigenAnterior nasal swabNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.31323B.1.621Mu1439C.36The product can detect different types of sample.2022-08-24 09:08:01 CET2546Immuno-AntigenYesNoImmunochromatographyQuantitativeSandwichColloidal gold15LOD396.22TCID50/ml2.5×10^2.2 TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives1.11%269 positive samples, 3 were false negative.False negatives3.05%131 positive samples, 4 were false negative.PrecisionEvaluatedAccuracy98.25%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.85%AntigenClinical Specificity98.88%AntigenType of antigenNucleocapsid protein1798Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva328Beijing Hotgen Biotech Co. Ltd.Chinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntigenSalivaThis kit is used for in vitro qualitative determination of novel coronavirus antigen in human saliva samples from posterior oropharynx. 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.2022-08-24 09:08:01 CET1477Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD250CalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0False negatives0PrecisionEvaluatedAccuracy98.79ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99.78%2810SARS-CoV-2 and Flu A/B Antigen Combo Rapid Test (Colloidal Gold)1256Beijing Hotgen Biotech Co. Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab689B.1.1.7Alpha1032B.1.351Beta1495P.1Gamma1132B.1.427Epsilon1137B.1.429Epsilon1320B.1.617.1Kappa1321B.1.617.2Delta1322B.1.617.32041C.37LambdaAdd 1 sample to get 3 results: SARS-CoV-2, Flu A and Flu B .2022-08-24 09:08:01 CET2515Immuno-AntigenYesNoImmunochromatographyQuantitativeSandwichColloidal gold15LODLimit of detection is 2.5*10^2.2TCID50/mLCalibrationNot evaluatedAnalysis of cross reactivityEvaluatedFalse positives0.24%410 negative samples have 1 false positives.False negatives3.38%207 positive samples have 7 false negatives.PrecisionEvaluatedAccuracy98.7%AntigenReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.62%AntigenClinical Specificity99.76%AntigenType of antigenNucleocapsid protein