COVID-19 Rapid Antibody Test
Manufactured by Biopanda Reagents LTD - https://www.biopanda.co.uk/
Device identification number
1016
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antibody
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
03/26/2021 11:13
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Clinical Sensitivity
69.4 % CI: 69.4 - 100
Clinical Specificity
98.3 % IgG
Clinical Specificity
96.7 % 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