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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 (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 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)
Fp
0 % Nasal Swab: 0/128
Fn
1.71 % (Nasopharyngeal Swab: 2/117)
Fn
2.83 % (Nasal Swab: 3/106)
Precision
Evaluated
Accuracy
99 %
Accuracy
98.73 % (Nasal Swab)
Accuracy
99 % (Nasopharyngeal Swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Sensitivity
97.25 % (Nasal Swab)
Clinical Sensitivity
98.32 % (Nasopharyngeal Swab)
Clinical Specificity
99 %
Clinical Specificity
100 % (Nasal Swab)
Clinical Specificity
99.6 % (Nasopharyngeal Swab)
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