V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography)
Manufactured by Guangzhou Decheng Biotechnology Co. Ltd., China - www.dochekbio.com
Device identification number
1324
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
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, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
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, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
74-105aa
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
2022-11-17 09:59:49 CET
Comments
Rapid diagnostic test
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other (IVD rapid test kit)
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
100 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.33 % (Nasopharyngeal swab)
False positives
0.33 % (Nasal swab)
False negatives
9.48 % (Nasopharyngeal swab)
False negatives
14.49 % (Nasal swab)
Precision
Evaluated
Accuracy
95.28 % (Nasal swab)
Accuracy
97.16 % (Nasopharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.52 % (Nasopharyngeal swab)
Clinical Sensitivity
85.51 % (Nasal swab)
Clinical Specificity
99.67 % (Nasopharyngeal swab)
Clinical Specificity
99.67 % (Nasal swab)
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