Overview
An estimated 2.3 million newborns die each year. Low- and middle-income countries bear the greatest mortality burden, with sepsis contributing 15%. It is estimated that 84% of newborn deaths due to infection could be averted through early diagnosis and appropriate clinical management. However, diagnostic tests for serious bacterial infection, including bacterial sepsis, among infants are either inadequate or entirely lacking in many settings.
The WHO target product profile for in vitro diagnostic tests for serious bacterial infection, including neonatal sepsis, among young infants aims to guide manufacturers, regulators and implementers in developing accessible, affordable tools that improve clinical decision-making, reduce unnecessary antibiotic use and save lives, especially in low-resource settings where the burden of neonatal sepsis remains critical.
Designed for both hospital and non-hospital settings, the target product profile defines the essential and desirable characteristics of tests to support early, accurate diagnosis among infants aged 0–59 days.