Coronavirus Ag Rapid Test Cassette (Swab)
Manufactured by Zhejiang Orient Gene Biotech Co. Ltd.
Device identification number
1343
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal 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
115 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.5 % (2/120)
False negatives
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