ASSURE SARS-CoV-2 IgG/IgM Rapid Test
Manufactured by MP Biomedicals, Germany - https://www.mpbio.com/eu/
Device identification number
937
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood with anti-coagulants
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Analysis of cross reactivity
Evaluated
Accuracy
99.43 %
Clinical Sensitivity
100 %
Clinical Specificity
99.41 %
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