SARS-CoV-2 IgM
Manufactured by Abbott Ireland Diagnostics Division, Ireland - www.corelaboratory.abbott
Device identification number
2774
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 IgM (also referred to as CoV-2 IgM). The SARS-CoV-2 IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
29 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.44 % (13 false positives out of a total of 2952 negative specimens)
False negatives
3 false negatives for specimens collected from positive subjects 15-30 days post-symptom onset.
Precision
Evaluated
Accuracy
96.67 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.67 % IgM
Clinical Specificity
99.56 % IgM
Type of antigen
Spike protein
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