COVICHEK COVID-19 Ag Saliva HT
Manufactured by WIZCHEM Co. Ltd., South Korea - www.wizchem.com
Device identification number
2652
CE Marking
✓Yes
HSC common list (RAT)
×No
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.351 (Beta), B.1.617.1 (Kappa), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
COVICHEK
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.98 %
False negatives
0.98 %
Precision
Evaluated
Accuracy
99.02 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.11 %
Clinical Specificity
99.78 %
Type of antigen
Spike 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