Industry News: Siemens Healthineers begins delivery of CE-IVD registered SARS-CoV-2 test kits

The molecular test kit promises 100% diagnostic sensitivity and specificity, and is authorized for clinical practice use in Europe

01 May 2020


Siemens Healthineers registered its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit for diagnostic use with the Luxembourg Ministry of Health. This registration of the kit, which was released for research use only (RUO) on April 2, 2020, allows for immediate rollout of the testing kit 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 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 21 and FTD FLU/HRSV, molecular syndromic testing panels from Siemens Healthineers 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.”

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 it is developing a SARS-CoV-2 serology assay to detect IgM and IgG antibodies in blood, helping indicate whether a person has developed immunity against SARS-CoV-2. An antibody test can reveal if a person had COVID-19 even if they were asymptomatic or never diagnosed with the disease.

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