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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

Manufactured by Hangzhou Realy Tech Co., Ltd, China - www.realytech.com 

Device identification number
1743
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
This product is being used currently by Westland Health on the Irish market with its customers. All positive candidates who have tested positive with the Realy antigen test kit, have been subsequently confirmed positive by the Irish Health Service.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
1250 U/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
Not Found
Fn
Not Found
Precision
Evaluated
Accuracy
98.79 %
Reproducibility
Not Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.14 %

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