Rapid 2019-nCoV IgG/IgM Combo Test
Manufactured by MP Biomedicals, Germany - https://www.mpbio.com/eu/
Device identification number
1126
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
Comments
https://www.mpbio.com/eu/2019-ncov-igg-igm-combo-test
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Analysis of cross reactivity
none for tested diseases; (HBsAb, TP antibody, HCV antibody, HIV antibody,Influenza Avirus antibody, Influenza Bvirus antibody, Respiratory syncytial virus antibody,Mycoplasmapneumoniae antibody, Chlamydia pneumonia antibody, Respiratory adenovirus antib
Precision
100 %
Accuracy
95.87 %
Clinical Sensitivity
94.74 %
Clinical Sensitivity
70.59 % IgM
Clinical Sensitivity
90.4 % IgG
Clinical Specificity
97.06 %
Clinical Specificity
99.67 % IgM
Clinical Specificity
97.39 % IgG
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