COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

VIDAS SARS-COV-2 IgG

Manufactured by bioMérieux SA, France - www.biomerieux.com/

Device identification number

881

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Automated, Manual

Target

Antibody, IgG

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Assay Type

Immuno-Antibody

Reader Required

Yes

Method

Immunoassay

Measurement

Qualitative

Time

30 minutes

Clinical Sensitivity

99.6 %

Clinical Specificity

100 %

Monitoring antibody response following SARS-CoV-2 infection: Diagnostic efficiency of four automated immunoassays
Molecular and Immunological Diagnostic Tests of COVID-19: Current Status and Challenges
Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation
Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020

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