Siemens Healthineers molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit is ready for immediate rollout for diagnostic use in Europe. This follows registration of the test kit for diagnostic use with the Luxembourg Ministry of Health. The test kit was released for research use only (RUO) on April 2, 2020.
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 analysed 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.
Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers, commented: “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. 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.
Siemens Healthineers anticipates availability of the total antibody test by late May 2020. Planned expanded production in the company’s Walpole, Massachusetts manufacturing facility will accommodate more than 25 million tests per month in June and beyond. The company is pursuing Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) as well as the CE Mark.
The test will be available on the Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour and will enable a result in just 14 minutes. In addition, the serology test also is expected to be available on the company’s expansive installed base of ADVIA Centaur XP and XPT analysers, which deliver up to 240 tests per hour, with a result in 18 minutes. Availability of this test on these industry leading platforms ensures more patients are tested in a shorter time.