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

2019-nCoV IgG/IgM Antibody Rapid Test Kit

Manufactured by Beijing Diagreat Biotechnologies Co., Ltd, China - www.diagreat.com/

Device identification number

960

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Automated, Manual

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

Detection Principle

Colorimetry

Crossreactivity

Reported

Notes

Manual or automated cassette Colloidal Gold

Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies
Antibody tests in detecting SARS-CoV-2 infection: A meta-analysis
Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020
Reliability and usefulness of a rapid IgM? IgG antibody test for the diagnosis of SARS-CoV-2 infection: a preliminary report

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