V-Chek 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography)
Manufactured by Guangzhou Decheng Biotechnology Co. Ltd., China - www.dochekbio.com
Device identification number
2909
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Card, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Saliva
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Rapid diagnostic test Card
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
LOD
100 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.17 %
False negatives
7.86 %
Precision
Evaluated
Accuracy
96.47 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.14 %
Clinical Specificity
98.83 %
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