We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Abbott Diagnostics

Siemens Healthineers

  Gold Provides customized electronic systems and advanced imaging, diagnostics, therapy, and healthcare IT solutions for th... read more Featured Products: More products

Download Mobile App





Siemens Healthineers Announces Availability of Molecular Fast Track Diagnostics SARS-CoV-2 Assay Test Kit

By LabMedica International staff writers
Posted on 02 Apr 2020
Print article
Illustration
Illustration
Siemens Healthineers (Erlangen, Germany) has released its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. The test kits are already being shipped within the European Union for research use only (RUO) to expedite availability, while the company continues to pursue Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for its clinical use. In addition, Siemens Healthineers has begun discussions with the US Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA). After regulatory approval, the commercial roll-out of the assay is intended in the US and Europe. While the controlled roll-out of the assay for research use is continuing, Siemens Healthineers is simultaneously expanding its production capacity.

The FTD SARS-CoV-2 Assay has been developed by Fast Track Diagnostics, a Siemens Healthineers company. It has been optimized on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler and utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits from Siemens Healthineers. It can be run in laboratories simultaneously with FTD Respiratory Pathogens 21, a molecular syndromic testing panel from Siemens Healthineers that identifies 21 different upper respiratory pathogens which can cause acute respiratory infections.

“With this molecular diagnostic assay, we want to make a contribution to fight the current COVID-19 global pandemic by delivering fast and accurate SARS-CoV-2 testing,” said Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers. “The Siemens Healthineers assay is designed to help researchers positively identify the virus in less than three hours so that healthcare professionals can proceed as quickly as possible with the necessary next steps on their patients’ triage paths.”

Related Links:
Siemens Healthineers


Print article

Channels

Microbiology

view channel
Image: Stenotrophomonas maltophilia colonies on sheep blood agar. Cultivation 48 hours in an aerobic atmosphere, 37 °C (Photo courtesy of microbiologyinpictures).

Global Spread of the Multi-Resistant Pathogen Stenotrophomonas Maltophilia Revealed

Stenotrophomonas maltophilia strains occur in several natural and human associated ecosystems. The bacterium was long regarded as relatively unproblematic, but is now considered to be one of the most feared... Read more
Copyright © 2000-2020 Globetech Media. All rights reserved.