SARS-CoV-2 Rapid Ag Test (Colloidal Gold)
Manufactured by Jiangsu Besthree Biotechnology Co. Ltd., China - www.besthree.com
Device identification number
3012
CE Marking
✓Yes
HSC common list (RAT)
×No
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Epstein-Barr Virus (EBV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV)
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No more additional information.
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
15 minutes
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3.42 %
False negatives
0.28 %
Precision
Evaluated
Accuracy
97.9 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.58 %
Clinical Specificity
99.72 %
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