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

2019-nCoV IgG/IgM Rapid Testing Kit

Manufactured by Vazyme - http://www.vazymebiotech.com/

Device identification number

766

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Physical Support

Cassette

Target

Antibody

Specimen

Plasma, Serum

Commercial Status

Commercialised

Last Update

03/22/2021 10:02

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Reader Required

Method

Immunoassay

Measurement

Qualitative

Time

10 minutes

Robustness

Evaluated

Clinical Sensitivity

91.54 %

Clinical Specificity

97.02 %

Type of antigen

nucleoprotein

Notes

Reliability of serological tests for COVID-19: Comparison of three immunochromatography test kits for SARS-CoV-2 antibodies
Immunological detection of serum antibodies in pediatric medical workers exposed to varying levels of SARS-CoV-2
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