Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 (SARS-CoV-2) Antigen Test Kit

Manufactured by Wuhan EasyDiagnosis Biomedicine Co., Ltd., China - http://www.easydiagnosis.com.cn/ 

Device identification number
2098
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow, Other
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.2 (Zeta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The COVID-19 (SARS-CoV-2) Antigen Test Kit manufactured by Wuhan EasyDiagnosis Biomedicine Co., Ltd. has passed PEI evaluation and approved with CE certification(DE/CA22/1311-538.1-IVD ), if you need any information please contact sales@easydiagnosis.com.cn
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
500 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
Not yet found
Fn
Not yet found
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 %
Clinical Specificity
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