Siemens' Fast Track Diagnostics SARS-CoV-2 Test Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 07 May 2020

Siemens Healthineers (Erlangen, Germany) has secured Emergency Use Authorization from the US Food and Drug Administration for its Fast Track Diagnostics SARS-CoV-2 test to detect the coronavirus that causes COVID-19.

The test has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity1. Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed. Up to 32 patient samples can be analyzed per kit. The FTD SAR-CoV-2 Assay can be run in laboratories simultaneously with FTD Respiratory Pathogens 213 and FTD FLU/HRSV3, molecular syndromic testing panels from Siemens that identify a wide range of pathogens that can cause acute respiratory infections.

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The SARS-CoV-2 Assay has been optimized for use with the BioMérieux EasyMag Extraction System and the Thermo Fisher Scientific Applied Biosystems 7500 Real-time PCR Thermocycler, although it can be validated for use with several other laboratory molecular instruments. Siemens had received CE marking for the test in April, allowing for its use as a clinical diagnostic test in Europe, and plans to ship more than 1.3 million tests per month worldwide.