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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 IgM

Manufactured by Abbott Ireland Diagnostics Division, Ireland - www.corelaboratory.abbott 

Device identification number
2774
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-11-19 05:34:27 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
Crossreactivity
Evaluated
Fp
0.44 % (13 false positives out of a total of 2952 negative specimens)
Fn
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