2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)
Manufactured by Beijing Beier Bioengineering Co. Ltd., China - https://www.beierbio.com
Device identification number
1359
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
131
False positives
Require clinical data comparison
False negatives
Require clinical data comparison
Accuracy
96.77 %
Clinical Sensitivity
94.12 % IgM
Clinical Sensitivity
95.1 % IgG
Notes
Manual NAT cassette 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