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COVID-19 CE-Marked K...

2nd October 2020  Product update: rapidmicrobiology staff writer

Top Scorer in WHO's COVID-19 Diagnostic Evaluation Release CE-Marked Winter Virus Test Kit


The VIASURE® Winter Multiplex CFR kit, that simultaneoulsy detects and identifies SARS-CoV-2, Influenza A/B and RSV in less than 80 minutes, has obtained CE-marking. 

The detection is done in one step real-time RT format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well. 

The isolated RNA target is transcribed generating complementary DNA by reverse transcriptase which is followed by the amplification of two conserved regions of N gene (N1 and N2) for SARS-CoV-2, a conserved region of the M1 gene for Flu A/B and a conserved region of the N gene for RSV A/B using specifics primers and a fluorescent-labelled probe.

Key Features & Benefits
  • Room temperature storage.

  • Lyophilised ready-to-use format; only need to add buffer and extracted sample

  • Two-year shelf life

  • Ability to pool mastermix to minimise waste

  • Validated with almost all extraction systems and cyclers as well as liquid handling platforms for high throughput automation.

 
The newly CE-marked VIASURE® Winter Multiplex kit is one of the first, true multiplex kits for the simultaneous detection of SARS-CoV-2, Influenza and Respiratory Syncytial Virus in a single well.

The kit is validated with almost all extraction systems and cyclers as well as liquid handling platforms for high-throughput automation. The VIASURE SARS-CoV-2 test released earlier in the year showed 100% diagnostic accuracy on multiple cyclers in a WHO-FIND study

Targets and Channels:

2042_table1

Data for the CE certification of the winter multiplex kit was generated in partnership with Oxford University Hospital, Liverpool Clinical Laboratories and Royal Cornwall Hospital. Full details are available in the Technical Report available on request.

Performance characteristics:

2042_table2

The Viasure range of RT-PCR kits is manufactured by CerTest Biotec and available exclusively from Pro-Lab Diagnostics in the UK and Canada.

The VIASURE® Winter Multiplex CFR kit will be an excellent addition to the extensive range of CE marked VIASURE® kits available from Pro-Lab Diagnostics. For downstream processing or further testing of winter respiratory pathogen samples, VIASURE® kits can offer the following testing algorithm:

ViaSureFluRSVCOVID19 


    

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Date Published: 2nd October 2020

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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