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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 Bio-Rad Laboratories / Zhejiang Orient Gene Biotech, China - www.bio-rad.com 

Device identification number
2031
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:08:22 CET
Comments
Product reference: 12015553 Packaging : 20 tests / box Storage : 2-30°C Total shelf life: 24 months
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
115 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.4 % (Nasopharyngeal Swab: 3/743 , Nasal Swab: 0/128)
Fn
1.71 % (Nasopharyngeal Swab: 2/117 , Nasal Swab: 3/106)
Precision
Evaluated
Accuracy
99 % (Nasopharyngeal Swab: 99,42% / Nasal Swab: 98,73%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 % (Nasopharyngeal Swab: 98,32% / Nasal Swab: 97,25%)
Clinical Specificity
99 % (Nasopharyngeal Swab: 99,6% / Nasal Swab: 100%)
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