STANDARD M M10 SARS-CoV-2

STANDARD™ M10 SARS-CoV-2 is a molecular in vitro diagnostic assay that aids in the detection of SARS-CoV-2 viral RNA based on nucleic acid amplification technology, real-time RT-PCR. STANDARD M10 SARS-CoV-2 is an all-in-one cartridge containing nucleic acid extraction and amplification reagents, which simplifies the testing process and allows users to obtain results within 60 minutes.

Intented UseMultiplex real-time RT-PCR test intended for use with STANDARD™ M10 system for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal) collected from individuals suspected of COVID-19.

Advantage

All-in-one cartridge (NA extraction + amplification)
Sensitivity of 100% and specificity of 100%
Result in 30-60 minutes (NA extraction + amplification)
One minute hands-on prep
Room temperature storage

Specification

Test methodReal-Time PCR
Detection or analysis geneORF1ab gene, E gene
Specimen typeNasopharyngeal swab (VTM/UTM)
Limit of detectionORF1ab gene ‒ 6.63 x10^-4 TCID₅₀/ml / E gene ‒ 6.63 x10^-4 TCID₅₀/ml
Sensitivity100% (109/109, 95% CI: 96.67% – 100%)
Specificity100% (120/120, 95% CI: 96.97% – 100%)
Test time60 minutes
Storage temperature 2~28℃
Test/Kit10 Tests

Ordering Information


Cat. No.	Product	Contents
11COV10A	STANDARD™ M10 SARS-CoV-2	SARS-CoV-2 Cartridge 10T/Kit
11M1011	STANDARD™ M10 Console	M10 Console 1 set
11M1012	STANDARD™ M10 Module	M10 Module 1 set