COVICHEK COVID-19 Ag KIT
Manufactured by WIZCHEM Co. Ltd., South Korea - www.wizchem.com
Device identification number
2661
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal 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
Since its establishment in 2008, WIZCHEM CO., LTD. has been researching, developing, and producing products with global competitiveness to meet customer needs in various fields such as functional chemical materials, biomedical cosmetics, hydrogel wound dressing and medical care. Based on these accumulated technology, for testing various viruses such as coronavirus, we have recently developed and produced in vitro diagnostic products such as viral transport medium(VTM) and swabs that collect and transport infectious virus samples, also viral DNA/RNA extraction kit and saliva collection kit for rapid and accurate diagnosis of diseases.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
0.011 ng/mL (1) Inactivated SARS-CoV-2 Virus 200-TCID50/mL, 2) Nucleocapid protein 0.011-ng/ml)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
99.02 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.11 %
Clinical Specificity
99.78 %
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