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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

V-Chek 2019-nCoV Ag Speichel Schnelltestkarte HGH

Manufactured by Guangzhou Decheng Biotechnology Co., LTD, China - www.dochekbio.com 

Device identification number
2244
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Strip
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
No unpleasant or painful swab of the throat or nose is required for the test. It is ideal for children, nurseries, playschools, schools and in the private sector.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Visualisation system
Method
Immunoassay
Measurement
Other
Time
10 minutes
LOD
97.12 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
2.88 % (95,65%)
Fn
1.56 % (98,44%)
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95 %
Clinical Specificity
98 %
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