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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.
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.
- 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
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Specification
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Test method
Real-Time PCR
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Detection or analysis gene
ORF1ab gene, E gene
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Specimen type
Nasopharyngeal swab (VTM/UTM)
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Limit of detection
ORF1ab gene ‒ 6.63 x10-4 TCID50/ml / E gene ‒ 6.63 x10-4 TCID50/ml
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Sensitivity
100% (109/109, 95% CI: 96.67% - 100%)
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Specificity
100% (120/120, 95% CI: 96.97% - 100%)
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Test time
60 minutes
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Storage temperature
2~28℃
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Test/Kit
10 Tests
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Test method
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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 - Download
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