Siemens Healthineers released a test kit to detect infection by the SARS-CoV-2 virus that causes the COVID-19 in less than three hours.
The company’s molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit is already being shipped within the European Union for research use only (RUO) to expedite availability while Siemens pursues Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for clinical use.
In addition, Siemens Healthineers has begun discussions with the U.S. Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA).
After regulatory approval, the company intends to roll out the assay for commercial use the U.S. and Europe.
In the meantime, Siemens Healthineers plans a controlled roll-out of the assay for research use while simultaneously expanding its production capacity.
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.
The FTD SARS-CoV-2 Assay has been optimized on the BioMerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler. The assay 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 that can cause acute respiratory infections.
