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SKU 11FLU10A

For professional/laboratory use only.

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.

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.

  • 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/kit

10 Tests/kit

Test method

Real-Time RT-PCR

Detection or analysis gene

Influenza A, Influenza B, RSV, ORF1ab gene, N gene

Specimen type

Nasopharyngeal swab (VTM/UTM) 300 μl

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%

Influenza B: 98.91%

RSV: 98.78%

SARS-CoV-2: 96.49%

Specificity

Influenza A: 100.00%

Influenza B: 99.82%

RSV: 100.00%

SARS-CoV-2: 98.73%

Test time

60 minutes

Storage temperature

2 ~ 28℃

Manufacturer's web: https://www.sdbiosensor.com/pr...

Additional information: piia@novabio.ee

Specifications

Specifications

Documents

M10_FluRSVSARS-CoV-2_IFU.pdf

IFU

EN | 2.254 MB

Download

M10_Flu_RSV_SARS-CoV-2_leaflet.pdf

Leaflet

EN | 942.274 KB

Download

M10_Flu_RSV_SARS-CoV-2_QuickGuide.pdf

Quick Guide

EN | 1.298 MB

Download

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Company

Nova Natura UAB

Kaštonų g. 56, Giraitės k, LT-54310,
Kaunas, Lithuania

nova@novabio.lt
Phone: +370 (620) 70159

Reg No 305063819

Nova Natura OÜ

Valukoja 8, 11415,
Tallinn, Estonia

nova@novabio.ee
Phone: +372 5656 0050

Reg No 14758203

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