SARS-CoV-2 IgM (Chemiluminescent Immunoassay)
Manufactured by Suzhou Hybiome Biomedical Engineering Co. Ltd., China - https://www.hybiome.com/
Device identification number
2043
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based
Target type
Antibody, IgM
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Adenovirus, Anti-Nuclear Antibody, Chlamydia Pneumoniae, Hepatitis C Virus (HCV), Influenza B, Mumps Virus (MuV), Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
S-RBD, physical support=Magnetic microparticles
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
CLIA
Measurement
Qualitative
Time
60 minutes
Detection Principle
Chemiluminescence
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.3 % IgM
False negatives
3 % IgM
Precision
Evaluated
Accuracy
98.3 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 % IgM
Clinical Specificity
98.7 % IgM
Type of antigen
Other
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