Screen Test Covid-19 - 2019-NCoV IgG/IgM Rapid Test Cassette
Manufactured by SCREEN ITALIA S.r.l., Italy - www.screenitalia.it
Device identification number
992
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Specimen
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
99 %
Accuracy
98.6 % IgG
Accuracy
92.9 % IgM
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
85 % IgM
Clinical Specificity
98 % IgG
Clinical Specificity
96 % 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