STANDARD M M10 Flu/RSV/SARS-CoV-2

STANDARD™ 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.

Intented UseSTANDARD™ 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 methodReal-Time RT-PCR
- Detection or analysis geneInfluenza A, Influenza B, RSV, ORF1ab gene, N gene
- Specimen typeNasopharyngeal swab (VTM/UTM) 300 μl
- Limit of detectionORF1ab gene ‒ 6.63 x10^-4 TCID₅₀/ml , E gene ‒ 6.63 x10^-4 TCID₅₀/ml
- SensitivityInfluenza 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/ [95% CI: 9 4 0 9% 99.97%], SARS-CoV-2: 96.49% (165/171) [95% CI: 96.69% 99.98%]
- SpecificityInfluenza 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: 00 % 100.00%], SARS-CoV-2: 98.73% (468/474) [95% CI: 97.72% 99.53%]
- Test time60 minutes
- Storage temperature2 ~ 28℃
- Test/Kit10 Tests