KaiBiLi COVID-19 Antigen
Manufactured by Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd., China - https://www.genesis-ivd.com
Device identification number
2085
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Our KaiBiLi COVID-19 Antigen is marketed in countries including Spain, Cyprus, Netherland, etc. It's been listed with different authorities of France, Germany, Belgium, and Czech.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
74.8 AU
False positives
0 % Zero
False negatives
0.4 % ((clinical sensitivity 96.6))
Precision
Evaluated
Accuracy
98.9 %
Reproducibility
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.6 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein
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