COVID-19 Antigen Test
Manufactured by Blue Cross Bio-Medical（Beijing） Co. Ltd., China - www.bcbmo.com
Device identification number
2627
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
COVID-19 Antigen Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasopharyngeal or pharyngeal swab specimens.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
8.33 %
False negatives
1.63 %
Precision
Evaluated
Accuracy
97.05 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.67 % ((Antigen))
Clinical Specificity
98.37 % ((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