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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SCREEN TEST COVID-19 IgG/IgM - 2019-nCoV IgG/IgM Rapid Test Cassette

Manufactured by SCREEN ITALIA S.r.l., Italy - www.screenitalia.it 

Device identification number
1787
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
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
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
0 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.76 % IgG (IgG: 1 on 21 )
False positives
10.5 % IgM (IgM: 2 on 19)
False negatives
0 % IgG IgG: 0 on 49
False negatives
5.88 % IgM (IgM: 3 on 51)
Precision
Evaluated
Accuracy
98.6 % ((95% CI: 92.3%-99.96%) )
Accuracy
92.9 ((95% CI: 84.1%-97.6%))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % ((95% CI: 86.0%-100%))
Clinical Sensitivity
85 % ((95% CI: 62.1%-96.8%))

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