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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (COVID-19) Antigen Detection Kit

Manufactured by Zhejiang Gene Science Co. Ltd., China - http://www.gene-science.com/ 

Device identification number
2684
CE Marking
Yes
HSC common list (RAT)
Yes
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
none
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Time
15 minutes
LOD
180 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.27 %
False negatives
5.42 %
Precision
Evaluated
Accuracy
96.81 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.58 %
Clinical Specificity
98.73 %
Type of antigen
Nucleocapsid protein

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