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Immunoassay for Earlier Diagnosis of Neonatal Sepsis to Enable Appropriate Interventions

By LabMedica International staff writers
Posted on 20 Oct 2023

Image: IL-6 is the first immunoassay approved to aid sepsis diagnosis in newborns (Photo courtesy of Roche)

Neonatal sepsis is a bloodstream infection that occurs in the first four weeks of a baby's life, and it comes with significant risks for severe illness or death. Because it often starts with vague symptoms but can quickly escalate to multiple organ failure, early detection and timely treatment are crucial. Babies with this condition don't usually show clear symptoms, making early diagnosis challenging. Measuring levels of IL-6 (interleukin-6) has proven useful in diagnosing neonatal sepsis early. IL-6 levels rise quickly in response to infection, quicker than other indicators, making it an effective early alert for inflammation, infection, or sepsis. Timely diagnosis allows healthcare providers to take immediate and suitable action, improving the chances for a good outcome for the newborn.

Roche’s (Basel, Switzerland) Elecsys IL-6 immunoassay is the first IL-6 test to be certified for use in the diagnosis of neonatal sepsis in countries accepting the CE Mark. The vitro diagnostic test quantitatively measures IL-6 levels in human blood serum and plasma. It helps doctors by enabling quicker identification of severe inflammatory responses, thereby speeding up the diagnosis of neonatal sepsis.

Faster diagnosis allows medical professionals to take quicker and more effective steps to improve the baby's prospects. The Elecsys IL-6 immunoassay is especially practical as it takes just 18 minutes to complete and requires only a small blood sample. Designed as an electrochemiluminescence immunoassay (ECLIA), the Elecsys IL-6 test is intended for use with cobas e immunoassay analyzers.

“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.”

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