COVID-19 Ag Test Kit
Manufactured by Guangdong Wesail Biotech Co. Ltd., China - http://en.wesailbio.com/
Device identification number
1360
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
80 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.3 %
False negatives
3.7 %
Precision
Evaluated
Accuracy
98.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.3 %
Clinical Specificity
99.7 %
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