Jan. 7, 2021–The FDA has issued an emergency use authorization for Siemens Healthineers’ laboratory-based IL-6 assay to measure the presence of interleukin-6 in human serum or plasma. The 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.
The IL-6 assay is available in the United States on Advia Centaur immunoassay systems, with results available in 18 minutes. It is also available outside the U.S. with the CE mark on Advia Centaur systems, the Atellica IM analyzer, and Immulite systems.