Siemens Begins Delivering CE-IVD Registered Coronavirus SARS-CoV-2 Test Kit

Siemens Healthineers (Erlangen, Germany) has registered its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay2 test kit for diagnostic use with the Luxembourg Ministry of Health, allowing for its immediate rollout for diagnostic use in Europe.

The test has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity. 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 company is also working to expand its infectious disease testing capabilities to address the COVID-19 pandemic in other areas of diagnostics. On April 23, the company announced that it is developing a SARS-CoV-2 serology assay4 to detect IgM and IgG antibodies in blood, helping indicate whether a person has developed immunity against SARS-CoV-2.

The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May 2020. 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.

“Having our molecular assay available for diagnostic use throughout the European Union is a major step forward in our contribution to the fight against the global pandemic,” said Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers. “I am grateful for the work and achievement of our Siemens Healthineers teams under difficult circumstances, and I hope our clinical test will help the healthcare professionals who are working on the frontlines of the pandemic and those affected by COVID-19.”