COVID-19 Antigen Rapid Test Cassette(Nasal Swab)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
1876
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
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 is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in Nasal swab.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
1000 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.008 AU
False negatives
0.068 AU
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
Notes
Human Coxsackie Virus, Haemophilusparainfluenzae, Staphylococcus aureus, Neisseria meningitides, Streptococcus sp. group A, Streptococcus sp. group B, Streptococcus sp. group C, Enterovirus EV68, Candida albicans, Haemophilus influenzae, and so on
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