SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)
Manufactured by JINAN BABIO BIOTECHNOLOGY Co. Ltd., China - zhou@jnbaibo.com
Device identification number
4046
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
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)
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)
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-09-20 02:32:24 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 nasal swabs and pharyngeal swabs. 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.
Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
N.A.
Detection Principle
N.A.
LOD
0 %
Calibration
Evaluated
Analytical Sensitivity
96.67 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
3.33 %
False negatives
0 %
Precision
Evaluated
Accuracy
99.4 %
Robustness
Evaluated
Clinical Sensitivity
96.67 %
Clinical Specificity
100 %
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