SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography)
Manufactured by Nanjing Bioworld Biotech Co. Ltd., China
Device identification number
3088
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Chromatography
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.01 AU
False negatives
0.01 AU
Precision
Evaluated
Accuracy
98.4 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.9 % (Antigen)
Clinical Specificity
98.11 % (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