SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) (anterior nasal swab)
Manufactured by Bioantibody Biotechnology Co. Ltd., China - http://www.baikangbiotech.com/index.php/product/49.html
Device identification number
3081
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Influenza A H1N1, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV) Type B, SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
no additional information
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
Sample collection device
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
10 %
Precision
Evaluated
Accuracy
98.07 % (antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 % (antigen)
Clinical Specificity
100 % (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