GLOBAL MEDICAL SURGERY EQUIPMENTS & PHARMA

GLOBAL MEDICAL SURGERY EQUIPMENT & PHARMA

M10 SARS-CoV-2

STANDARD™ M10 SARS-CoV-2 qualitatively detects SARS-CoV-2 virus infection by extracting and amplifying the nucleic acids from nasopharyngeal swab or oropharyngeal swab samples. Reverse transcription real-time polymerase chain reaction (Real-time RT-PCR) is used to amplification and detection of SARS-CoV-2.

Indented 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% (Ref.no: SDB-CS-MNCOV03)
  • Result in 20-60 minutes (NA extraction + amplification)
  • One minute hands-on prep
  • Multiplex using FAM/HEX/Cy5
  • Room temperature storage

 

Category:

STANDARD™ M10 SARS-CoV-2 qualitatively detects SARS-CoV-2 virus infection by extracting and amplificating the nucleic acids from nasopharyngeal swab or oropharyngeal swab samples. Reverse transcription real-time polymerase chain reaction (Real-time RT-PCR) is used to amplification and detection of SARS-CoV-2.

Specifications

Test method: All-in-one Cartridge. Nucleic acid extraction/isolation : Column Method / Nucleic acid amplification : RT-PCR
Detection or analysis gene ORF1ab gene, E gene / Internal Control (IC)
Specimen type: Nasopharyngeal swab, oropharyngeal swab in VTM
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: 20-60 mins
Storage temperature: 2~28℃
Test/Kit: 10 Tests/kit