The World Health Organization (WHO) has introduced a target product profile aimed at enhancing the development of in vitro diagnostic (IVD) tests for serious bacterial infections, such as neonatal sepsis, in newborns and young infants. This initiative seeks to fill current diagnostic gaps and ultimately reduce infant mortality rates, particularly in low- and middle-income countries where 2.3 million newborn deaths occur annually, with sepsis being a significant contributor. The profile focuses on developing cost-effective and sensitive diagnostic tools that can improve clinical decision-making in various healthcare settings, ensuring timely and appropriate management of infections.
Mapping Out Standards for Newborn Sepsis Diagnostics
Target product profile highlights priority settings and performance needs for newborn diagnostic tests
08/22/2025
News
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