Kewei COVID-19 IgM antibody ELISA Test Kit
Manufactured by Beijing Kewei Clinical Diagnostic Reagent Inc., China - en.keweidiagnostic.com/
Device identification number
67
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
N.A.
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
60 minutes
Subclass
Capture
Accuracy
96 % IgM
Clinical Sensitivity
90.83 % IgM
Clinical Specificity
99.6 % IgM
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