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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Coronavirus (2019-nCoV)-Antigentest

Manufactured by Beijing Hotgen Biotech Co., Ltd., China - www.hotgen.com.cn 

Device identification number
2807
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Herpes Simplex (HSV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, 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
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), P.1 (Gamma), C.37 (Lambda),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
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.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Sandwich
LOD
TCID50/ml Limit of detection is 5*10^1.2TCID50/mL
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.11 % (The 269 negative samples, 3 of them is false positives.)
Fn
3.05 % (The 131 positive samples, 4 of them should is false negatives)
Precision
Evaluated
Accuracy
% 98.25(Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.95 % (Antigen)
Clinical Specificity
98.88 % (Antigen))
Type of antigen
Nucleocapsid protein

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements