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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

KaiBiLi Flu & COVID-19 Antigen Duo

Manufactured by Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd., China - https://www.genesis-ivd.com 

Device identification number
2890
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza B, SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), 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
KaiBiLi Flu & COVID-19 Antigen Duo Rapid Test is intended for the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasal specimens. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of virus.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
140 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3.4 %
Precision
Evaluated
Accuracy
98.9 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.6 % (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