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

GenBody COVID-19 IgM/IgG

Manufactured by GenBody, Inc, South Korea - www.genbody.co.kr/index.php?&LANGUAGE=en

Device identification number

169

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Target

Antibody, IgG, IgM

Specimen

Whole blood

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Crossreactivity

Reported

Accuracy

96.5 %

Clinical Sensitivity

91.7 %

Clinical Specificity

97.5 %

Notes

Rapid diagnostic test cassette

Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2
Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies
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