Siemens IL-6 Test for COVID-19 Response Granted FDA Emergency Use Authorization

Siemens Healthineers (Erlangen, Germany) has been granted an Emergency Use Authorization by the US Food and Drug Administration for its laboratory-based IL-6 assay to measure the presence of interleukin-6 in human serum or plasma.

The Interleukin-6 (IL-6) assay is an important tool that can assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. It is an early indicator of inflammatory response to illness or injury.

An important mediator of the immune response to pathogens, IL-6 is a member of the cytokine class of chemical messengers that induces both pro- and anti-inflammatory responses. It plays a significant role in the development and escalation of CS in COVID-19 patients. The integration of IL-6 into COVID-19 testing protocols can help clinicians stay ahead of cytokine storm by assisting in the identification of severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, when used in conjunction with clinical findings.

The Siemens IL-6 assay is available across the US on the ADVIA Centaur XP, XPT and CP Systems. Outside the US, the IL-6 assay is available with the CE mark on the ADVIA Centaur Systems, Atellica IM Analyzer and IMMULITE Systems.