SARS-CoV-2 IgM (CLIA)
Manufactured by MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd., China - www.medcaptain.com
Device identification number
1710
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Cassette
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
CLIA
Measurement
Qualitative
Time
25 minutes
Detection Principle
Chemiluminescence
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.2 % IgM
False negatives
6.2 % IgM
Precision
Evaluated
Accuracy
97.4 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.8 % 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