COVID-19 Antigen Rapid Test
Manufactured by WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING Co. Ltd., China - www.whkangzhou.com
Device identification number
2688
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
860 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3.2 %
False negatives
0.4 %
Precision
Evaluated
Accuracy
93.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.8 %
Clinical Specificity
99.6 %
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