V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography)
Manufactured by Guangzhou Decheng Biotechnology Co. Ltd., China - www.dochekbio.com
Device identification number
1883
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
2019-nCoV Ag Saliva Rapid Test Card ; The Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset. This Card uses a double-antibody sandwich to detect the antigen presence of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex. The reaction complex moves along the nitrocellulose membrane under the action of chromatography. It is then captured by the anti-2019-nCoV monoclonal antibody pre-coated in the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
100 %
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
A reaction time of less than 15 minutes may lead to a false negative result
False negatives
A reaction time of more than 15 minutes may lead a false positive result.
Precision
Evaluated
Accuracy
97.12 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.65 %
Clinical Specificity
98.44 %
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