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

VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit for BD MAX System

Manufactured by CerTest Biotec, S.L. - https://www.certest.es/

Device identification number

123

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Manual

Target

Nucleic acid

Commercial Status

Commercialised

Last Update

03/26/2021 03:23

Assay Type

Nucleic acid-PCR

Method

RT-PCR

LOD

24 copies/rxn

Positive control

yes

Negative control

yes

Type of antigen

ORF1ab gene and N gene

Notes

https://www.certest.es/wp-content/uploads/2020/03/IU-NCO212enes1120-rev.02.pdf

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
International external quality assessment for SARS-CoV-2 molecular detection and survey on clinical laboratory preparedness during the COVID-19 pandemic, April/May 2020
Assay Techniques and Test Development for COVID-19 Diagnosis.
Lack of sensitivity of an IVD/CE-labelled kit targeting the S gene for detection of SARS-CoV-2

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