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

SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)

Manufactured by BIOHIT HealthCare (Hefei) Co., Ltd, China - www.biohit.cn

Device identification number

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Physical Support

Strip

Target

Antibody, IgG, IgM

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

Colloidal gold

Clinical Sensitivity

97.5 %

Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2
Molecular and Immunological Diagnostic Tests of COVID-19: Current Status and Challenges
Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies
How should diagnostic kits development adapt quickly in COVID 19-like pandemic models? Pros and cons of sensory platforms used in COVID-19 sensing
Multi-site Validation of a SARS-CoV-2 IgG/IgM Rapid Antibody Detection Kit

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