SARS-CoV-2 IgM
Manufactured by DIALAB GmbH, Austria - www.dialab.at/en/home/
Device identification number
1054
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate
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
Immunoassay
Measurement
Qualitative
Time
70 minutes
Detection Principle
Magnetic Electrochemical
Analysis of cross reactivity
Evaluated
Clinical Sensitivity
96.49 % ((165/171))
Clinical Specificity
98.15 % ((742/756))
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