Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test
Manufactured by Beijing Jinwofu Bioengineering Technology Co. Ltd., China - www.jwfbio.com/en/
Device identification number
1725
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
100
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 AU
False negatives
10 AU
Precision
Evaluated
Accuracy
98.82 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.88 %
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