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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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
2022-04-20 12:09:38 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
Crossreactivity
Evaluated
Fp
2.5 % (2/120)
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