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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.

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Intented Use

Multiplex 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 method

      Real-Time PCR

    • Detection or analysis gene

      ORF1ab gene, E gene

    • Specimen type

      Nasopharyngeal swab (VTM/UTM)

    • Limit of detection

      ORF1ab gene ‒ 6.63 x10-4 TCID50/ml / E gene ‒ 6.63 x10-4 TCID50/ml

    • Sensitivity

      100% (109/109, 95% CI: 96.67% - 100%)

    • Specificity

      100% (120/120, 95% CI: 96.97% - 100%)

    • Test time

      60 minutes

    • Storage temperature

       2~28℃

    • Test/Kit

      10 Tests

  • Ordering Information
    주문정보의 cat. no., 제품명, pack size, 비고
    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
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