Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva)
Manufactured by Innovation Biotech(Beijing) Co. Ltd., China - www.invbio.com
Device identification number
2332
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Card, Cassette
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human saliva, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronvirus antigen. It will provide information for clinical doctors to prescribe correct medications.
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunochromatography
Time
15 minutes
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.9 %
False negatives
1 %
Precision
Evaluated
Accuracy
99.57 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 %
Clinical Specificity
99 %
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