SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)
Manufactured by JINAN BABIO BIOTECHNOLOGY CO., LTD., China
Device identification number
2151
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Card
Target
Antigen
Specimen
Nasal swab, Oropharyngeal swab, Saliva
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV)
Lineages detected
Commercial Status
Commercialised
Last Update
2021-05-31 01:31:10 CET
Comments
SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay intended for the qualitative detection of nucleoprotein from SARS-CoV-2 innasal swabs,pharyngeal swabs,saliva. It is used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with individuals suspected of COVID-19.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
3.62 %
Fn
0 %
Precision
Evaluated
Accuracy
98.79 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.38 % (（Antigen）)
Clinical Specificity
100 %
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