COVID-19 IgG/IgM Ab Rapid Test
Manufactured by Biogate Laboratories Ltd., Canada - www.biogatelab.com/index.html
Device identification number
776
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
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
15 minutes
Analysis of cross reactivity
Reported
Accuracy
93.33 % IgM
Accuracy
96.17 % IgG
Clinical Sensitivity
87.54 % IgM
Clinical Sensitivity
92.88 % IgG
Clinical Specificity
98.43 % IgM
Clinical Specificity
99.06 % IgG
Notes
Rapid diagnostic test lateral flow
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