Coronavirus Ag Rapid Test Cassette (Swab)
Manufactured by Zhejiang Orient Gene Biotech Co., China - http://www.orientgene.com/
Device identification number
1965
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
04/08/2021 03:35
Comments
Performance on Nasal Swab: Sensitivity: 97.25% Specificity: 100% Accuracy: 98.73% CE Certificate specific to Bio-Rad
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
115 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
2.5 % 3/120
Fn
0.27 % 2/745
Precision
Evaluated
Accuracy
99.42 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.32 %
Clinical Specificity
99.6 %
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