NEW YORK ─ The US Food and Drug Administration 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 firm said on Thursday.
Erlangen, Germany-based Siemens Healthineers said its blood test may be used to assist in identifying a severe inflammatory immune response in patients confirmed to have COVID-19, and to aid in determining the risk of needing intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.
Emergency use of the test, limited to authorized laboratories, was granted by the FDA in December.
IL-6 is an indicator of the potential for a severe inflammatory response in patients with confirmed SARS-CoV-2 infection. It is a type of cytokine, or intercellular messenger molecule, that plays a central role in the immune response to infection and can evoke many different actions when it is released.
The IL-6 assay is available in the US for use with Siemens Healthineers' Advia Centaur immunoassay systems, which provide a time-to-result of 18 minutes, and it is available outside the US with CE-marking for use with the firm's Advia Centaur, Atellica IM, and Immulite systems.
Last August, Siemens Healthineers became the first company to receive FDA EUA for a semi-quantitative serology test.
Roche and Beckman Coulter also have EUAs for IL-6 tests.