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STANDARD™ M10 SARS-CoV-2 (10T/kit) (CE-IVD)

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SKU 11COV10A

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For professional/laboratory use only.

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
  • One minute hands-on preparation
  • Room temperature storage

Product specification

Test/kit

10 Tests/kit

Test method

Real-Time RT-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%

Specificity

100%

Test time

60 minutes

Storage temperature

2 ~ 28℃

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

Additional information: piia@novabio.ee

Specifications

Specifications
Qty./Pk

10 Tests/kit

Sample Type

Nasopharyngeal swab (VTM/UTM)

Application

ORF1ab gene, E gene

Documents

M10_SARS-CoV-2_IFU.pdf

IFU

EN | 1.553 MB

Download

M10_SARS-CoV-2_leaflet.pdf

Leaflet

EN | 959.548 KB

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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