The World Health Organization (WHO) has released a new target product profile to guide the development of in vitro diagnostic (IVD) tests for detecting serious bacterial infections, including neonatal sepsis, in newborns and young infants. The initiative aims to address current diagnostic gaps and improve early detection to reduce infant mortality worldwide.
An estimated 2.3 million newborns die each year, with low- and middle-income countries experiencing the highest burden. Sepsis accounts for roughly 15 percent of these deaths. According to WHO, evidence indicates that 84 percent of newborn deaths from infection could be prevented with timely diagnosis and appropriate clinical management.
Current diagnostic approaches for serious bacterial infections – such as blood cultures and molecular assays – often face challenges in sensitivity, turnaround time, cost, and infrastructure requirements. Many methods are either unavailable or unaffordable, particularly outside major hospital settings. In some locations, clinicians rely on clinical signs alone to determine whether to initiate antibiotic treatment or refer a newborn to hospital care, increasing the risk of both missed diagnoses and unnecessary antibiotic use.
The target product profile outlines essential and desirable characteristics for new IVD tests intended for infants aged 0-59 days. It addresses two primary use cases:
Primary health care settings: Tools to help identify newborns and young infants requiring referral to hospital for further evaluation and/or treatment with antibiotics.
Hospital settings: Tests to guide decisions on initiating bacterial sepsis management and antibiotic therapy for infants with suspected serious bacterial infections.
WHO states that effective tests should improve clinical decision-making, reduce unnecessary antibiotic exposure, and help combat antimicrobial resistance. The guidance emphasizes suitability for low-resource settings, where the burden of neonatal sepsis remains high and access to reliable laboratory diagnostics is limited.
The target product profile is intended for diagnostic manufacturers, regulatory agencies, health ministries, and other stakeholders engaged in developing and implementing diagnostic technologies. It was developed by WHO’s Department of Antimicrobial Resistance in collaboration with the Department of Maternal, Child Health and Ageing, and with contributions from the Research for Health Department. FIND (the global alliance for diagnostics) and members of the target product development group also contributed to its creation.
By defining test performance, operational, and implementation criteria, the WHO target product profile provides a framework to encourage the development of accessible, accurate, and rapid diagnostics for serious bacterial infections in newborns and young infants – tools that could support more targeted treatment and improved patient outcomes in diverse clinical settings.
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