Siemens Healthineers Releases Test Kit for Coronavirus COVID- 19 in Canada


• Siemens Healthineers test kit will help detect SARS-CoV-2, the cause of COVID-19
• Test 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

Siemens Healthineers announced today the availability of its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to detect the severe respiratory syndrome coronavirus 2 (SARS-CoV-2) virus that causes the COVID-19 disease.

“With this molecular diagnostic assay, we want to make a contribution to fight the COVID-19 pandemic by delivering fast and accurate SARS-CoV-2 testing,” said Sevket On, VP and Zone General Manager, Canada. “The Siemens Healthineers assay is designed to help physicians positively identify the virus in less than three hours so that health decisions can be made quickly to treat patients and catch infections early,”

Many molecular assays detect the presence of viral ribonucleic acid (RNA), determining the presence of the targeted virus directly in the patient sample. In this way, molecular testing is effective early in the lifecycle of the virus and is thus efficient in urgent testing situations, such as global pandemics.

This 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. The FTD SARS-CoV-2 Assay has been optimized on the Biomerieux EasyMag Extraction System, the Applied Biosystems 7500 Real-time PCR Thermocycler and the Siemens VERSANT kPCR Molecular System and utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits from Siemens Healthineers.

The FTD SARS-CoV-2 Assay was developed by Fast Track Diagnostics, a Siemens Healthineers Company, in Esch-sur-Alzette, Luxembourg. Fast Track Diagnostics was acquired by Siemens Healthineers at the end of 2017.

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