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FTD SARS-CoV-2 Assay

FTD SARS-CoV-2 Assay1

 

Respiratory Testing

For the specific detection of the coronavirus causing COVID-19

In late 2019, China notified the World Health Organization (WHO) of a novel strain of coronavirus. This virus, now named SARS-CoV-2, targets the epithelial cells of the respiratory tract and causes infection that can lead to Coronavirus disease 2019 (COVID-19). Siemens Healthineers new molecular assay uses real-time PCR to detect RNA from this virus.

Features & Benefits

  • Kit comprised of a single-well dual target assay for the specific detection of SARS-CoV-2 (COVID-19)
  • Designed for high sensitivity, specificity, and inclusivity
  • Covers highly conserved regions within ORF1ab and N gene
  • Uses the same assay setup protocol and thermal-cycling profile as all FTD respiratory disease kits

For more information, please contact your Siemens Healthineers representative

This test has been authorized for sale by Health Canada under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, and has not been licensed under the Health Canada Medical Devices Regulation. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the Interim Order, for a period of up to one year, unless it is renewed or unless the authorization is cancelled sooner. Product availability may vary by country and is subject to varying regulatory requirements.