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

COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit

Manufactured by Anhui Deep Blue Medical Technology Co., Ltd, China - www.dbluemedical.com/

Device identification number

510

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

Detection Principle

Colorimetry

Notes

Rapid diagnostic test Strip Colloidal Gold

Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2
The diagnostic value of rapid anti IgM and IgG detecting tests in the identification of patients with SARS CoV-2 virus infection
Molecular and Immunological Diagnostic Tests of COVID-19: Current Status and Challenges
COVID-19 Serological Tests: How Well Do They Actually Perform?
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