Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)

Manufactured by Realy Tech, China - www.realytech.com 

Device identification number
2298
CE Marking
Yes
HSC common list (RAT)
×No
Physical Support
Cassette
Target type
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
For more information please see the website
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Extraction kit
Method
Immunochromatography
Time
15 minutes
LOD
12.5 AU/mL
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
209 AU
Fn
450 AU
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99 % ((>99,9))
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