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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)

Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn 

Device identification number
1868
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasopharyngeal swab.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
1000 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.0053 AU
False negatives
0.008 AU
Precision
Evaluated
Accuracy
99.41 % (Antigen)
Robustness
Evaluated
Clinical Sensitivity
99.2 % (Antigen)
Clinical Specificity
99.47 % (Antigen)
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