COVID-19 Antigen Rapid Test Cassette(Nasal Swab)(Self-testing)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
2882
CE Marking
✓Yes
HSC common list (RAT)
×No
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus, Rhinovirus A, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19 Antigen Rapid Test Cassette(Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasal Swab in symptomatic individuals.
Assay Type
Immuno-Antigen
Self Test
Yes
Method
Immunoassay
Time
10 minutes
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.008 %
False negatives
0.068 %
Precision
Evaluated
Accuracy
97.5 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.2 % (Antigen)
Clinical Specificity
99.2 % (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