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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

A&B RAPID TEST COVID-19 IGG/IGM CASSETTA

Manufactured by A&B Professional, Italy - www.aebrapidtest.com/ 

Device identification number
1004
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Accuracy
99.6 % IgG
Accuracy
97.8 % IgM
Accuracy
98.2 % (IgG+IgM)
Clinical Sensitivity
94.1 % (IgG+IgM)
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
91.8 % IgM
Clinical Specificity
99.2 % (IgG+IgM)
Clinical Specificity
99.5 % IgG
Clinical Specificity
99.2 % 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