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Siemens Healthineers’ IL-6 Test receives U.S. FDA EUA to help assess dysregulated inflammation in COVID-19 patients

Siemens Healthineers announced 7 January that the U.S. FDA has issued an Emergency Use Authorization (EUA) for their laboratory-based IL-6 assay to measure the presence of Interleukin-6 (IL-6) in human serum or plasma. IL-6 is an indicator of potential severe inflammatory response in patients with confirmed SARS-CoV-2 infection. Emergency use of this test is limited to authorized laboratories in the U.S.

This simple blood test may be used to assist in identifying a severe inflammatory immune response in patients confirmed to have COVID-19, to aid in determining the risk of needing intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Approximately five percent of COVID-19 patients develop a systemic dysregulated cytokine response known as cytokine storm.

IL-6 is a type of cytokine (intercellular messenger molecule) that plays a central role in the immune response to infection and can evoke many different actions when it is released. It is substantially elevated in patients presenting with cytokine storm. Cytokine release is a normal part of the body’s immune response when fighting off a virus. However, a severe immune response can cause overproduction of cytokines leading to potential wide-scale cellular and organ damage, and ultimately death. IL-6 levels were found to be higher in COVID-19 patients with severe disease.

“The Siemens Healthineers’ IL-6 assay is an important tool for the care of hospitalized COVID-19 patients,” said Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers.

Siemens Healthineers’ IL-6 assay is currently available across the U.S. on the ADVIA Centaur Immunoassay Systems, the largest installed base of instruments in the U.S., with a time-to-result of 18 minutes. The IL-6 assay is also available outside the U.S. with the CE mark on the ADVIA Centaur Systems, Atellica IM Analyzer and IMMULITE Systems.

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