Zhenrui ®COVID-19 Antigen Test Cassette
Manufactured by Shenzhen Zhenrui Biotechnology Co. Ltd., China - en.zr-bio.com/en/
Device identification number
1574
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
12 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
96.5 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % (Antigen)
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