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

CORONAVÍRUS IgG/IgM (COVID-19)

Manufactured by Ebram Produtos Laboratoriais Ltd - http://www.ebram.com/

Device identification number

543

CE Marking

×No

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Physical Support

Cassette

Target

Antibody, IgG, IgM

Specimen

Whole blood

Commercial Status

Commercialised

Last Update

04/16/2021 03:20

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

Method

Immunoassay

Measurement

Qualitative

Time

20 minutes

Crossreactivity

Reported

Clinical Sensitivity

99 %

Clinical Specificity

98 %

The different tests for the diagnosis of COVID-19 - A review in Brazil so far
COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil
Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies
Assay Techniques and Test Development for COVID-19 Diagnosis.

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