2019-nCoV IgG/IgM Device
Manufactured by AMS UK (NI) Ltd., United Kingdom - www.amslabs.co.uk
Device identification number
1048
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
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
10 minutes
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
95 % IgG
Accuracy
96.7 % IgM
Clinical Sensitivity
91.8 % IgG
Clinical Sensitivity
95.7 % IgM
Clinical Specificity
96.4 % IgG
Clinical Specificity
97.3 % IgM
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