Rapid Immunoassay Test Cassette
Manufactured by SureScreen Diagnostics, United Kingdom - www.surescreen.com
Device identification number
466
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
False positives
Evaluated
False negatives
Evaluated
Accuracy
99.6 % IgG
Accuracy
97.8 % IgM
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
91.8 % IgM
Clinical Specificity
99.5 % IgG
Clinical Specificity
97.2 % 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