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

DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit

Manufactured by Solgent Co., Ltd, South Korea - www.solgent.com

Device identification number

376

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Lab-based

Target

Nucleic acid

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Comments

No cross reaction with other human Coronavirus strains: NL63, HKU1 & OC43

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Time

120 minutes

LOD

10 copies/reaction

Positive control

yes

Negative control

yes

Analitical Specificity

tested negative with 38 species of microorganisms

Throughput

single tubes

Notes

http://www.solgent.com/english/sub03020102/view/id/45

Real-time PCR-based SARS-CoV-2 detection in Canadian laboratories
Molecular and Immunological Diagnostic Tests of COVID-19: Current Status and Challenges
Assay Techniques and Test Development for COVID-19 Diagnosis.
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