Roche has announced that its Elecsys IL-6 immunoassay has become the first interleukin-6 (IL-6) test to have a certified claim for use in diagnosis of neonatal sepsis, in countries accepting the CE Mark.
Elecsys IL-6 aids physicians in combating the impact of neonatal sepsis by facilitating an early diagnosis. Early and improved diagnosis can contribute to appropriate use of antibiotics, as well as potentially decreasing mortality rates and mitigating long-term consequences of sepsis.
“Sepsis is one of the leading causes of death in newborns and we need to do everything we can to prevent these deaths," said Matt Sause, CEO of Roche Diagnostics. "Receiving the first approval for IL-6 use with newborns, is a significant step forward in helping clinicians confidently diagnose neonatal sepsis earlier and save more lives.”
Neonatal sepsis is an infection involving the bloodstream within the first four weeks of life and results in high rates of morbidity and mortality. Neonatal sepsis can initially present with subtle signs but can rapidly progress to multisystem organ failure. Early detection and prompt intervention are essential to prevent severe and life-threatening complications.
Testing IL-6 is suitable for early diagnosis of neonatal sepsis as it increases rapidly in response to infection, much earlier than other markers, making it a better early warning marker of inflammation, infection, or sepsis. With earlier diagnosis, clinicians can make earlier and more appropriate interventions to give neonates the best chance of a positive outcome. The Elecsys IL-6 can help to achieve this with the test only taking 18 minutes to run and only using a small amount of blood.
Elecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum and plasma. This assay is used to assist in identifying severe inflammatory responses in patients. A test takes 18 minutes to run and only needs a sample volume of 30 μL (cobas e411, e601, e602); or 18 μL (cobas e402, e801), one of the smallest volumes on the market. The Elecsys IL-6 immunoassay is an electrochemiluminescence immunoassay (ECLIA) and is intended for use on cobas e immunoassay analysers.
The claim certification is supported by an investigator-initiated study (IIS) from the Medical University of Vienna, evaluating ~8500 Elecsys IL-6 measurements from 1695 neonates. Elecsys IL-6 demonstrated excellent performance for the detection of neonatal sepsis. AUC = 0.92 (95% CI: 0.89–0.94), Global specificity 88% (95% CI: 83–92%), Global sensitivity 82% (95% CI: 77–86%).