Kewei COVID-19 total antibody rapid test
Manufactured by Beijing Kewei Clinical Diagnostic Reagent Inc., China - en.keweidiagnostic.com/
Device identification number
1112
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://en.keweidiagnostic.com/uploadfile/2020/0704/20200704024137750.pdf
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
Clinical Sensitivity
93.33 %
Clinical Specificity
99.6 %
Notes
Manual or automated Colloidal Gold
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