TANDARD M10 Flu/RSV/SARS-CoV-2 is a molecular in vitro diagnostic assay that aids in the simultaneous detection and identification of Influenza A, Influenza B, RSV, and SARS-CoV-2 viral RNA based on nucleic acid amplification technology, real-time RT-PCR. STANDARD M10 Flu/RSV/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 1 hour.

Intended Use

STANDARD M10 Flu/RSV/SARS-CoV-2 is a multiplex real-time RT-PCR test intended for use with STANDARD M10 system for the qualitative detection of Influenza A, Influenza B, RSV and SARS-CoV-2 nucleic acids in human nasopharyngeal swab specimen.

Advantage

• All-in-one cartridge (NA extraction + amplification)

• Simultaneous detection and identification of Flu A, Flu B, RSV and SARS-CoV-2

• Real-time RT-PCR result in 1 hour

• One minute hands-on preparation

• Room temperature storage

Specification

Test method Real-Time RT-PCR

Detection or analysis of gene Influenza A, Influenza B, RSV, ORF1ab gene, N gene

Specimen type Nasopharyngeal swab (VTM/UTM) 300μl

Limit of detection Influenza virus: Flu A H1N1 pdm (399 copies/mL), Flu A H1 (631 copies/mL), Flu A H3 (525 copies/mL), Flu B (399 copies/mL)

RSV: RSV A (795 copies/mL), RSV B (2,631 copies/mL) / SARS-CoV-2: ORF1ab gene (813 copies/mL), N gene (795 copies/mL)

Sensitivity Influenza A: 98.18% (108/110) [95% CI: 93.59% – 99.78%], Influenza B: 98.91% (91/92) [95% CI: 94.09% – 99.97%],

RSV: 98.78% (81/82) [95% CI: 93.39% – 99.97%], SARS-CoV-2: 96.49% (165/171) [95% CI: 96.69% – 99.98%]

Specificity Influenza A: 100.00% (535/535) [95% CI: 99.31% – 100.00%], Influenza B: 99.82% (552/553) [95% CI: 99.00% – 100.00%],

RSV: 100.00% (563/563) [95% CI: 99.35% – 100.00%], SARS-CoV-2: 98.73% (468/474) [95% CI: 97.72% – 99.53%]

Test time 60 minutes

Storage temperature 2 ~ 28℃

Test/Kit 10 Tests