The World Health Organization (WHO) has developed a target product profile (TPP) for serious bacterial infection among young infants. This includes neonatal sepsis, which kills 15% of the estimated 2.3 million newborns who die annually.
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 TPP 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 TPP defines the essential and desirable characteristics of tests to support early, accurate diagnosis among infants aged 0–59 days.
You can find the full TPP document here.
