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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

The SARS-CoV-2 Antigen Assay Kit (Immunochromatography)

Manufactured by Wuhan Life Origin Biotech Joint Stock Co., Ltd., China - www.szybio.com 

Device identification number
1773
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Card, Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-07-13 06:02:47 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
0 U/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.71 % ((6/350),95%CI(0.63%-3.69%))
Fn
7.33 % ((11/150),95%CI(3.72%-12.74%))
Precision
Evaluated
Reproducibility
96.6 % ((483/500), 95%CI (94.61%-98.01%))
Robustness
Evaluated
Clinical Sensitivity
92.67 % ((139/150), 95%CI (87.26%-96.28%))

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