Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva)
Manufactured by Innovation Biotech(Beijing) Co. Ltd., China - www.invbio.com
Device identification number
2285
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
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
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
15 minutes
LOD
125 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3.27 %
False negatives
1.32 %
Precision
Evaluated
Accuracy
98.68 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.73 %
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