WHO Releases Target Product Profile for Newborn Infection Diagnostics to Reduce Infant Mortality
Lab leaders can now align with WHO’s new product profile to develop innovative diagnostics that address gaps in newborn infection detection and antimicrobial resistance prevention.
The World Health Organization (WHO) has unveiled a new target product profile aimed at guiding the development of in vitro diagnostic tests for detecting serious bacterial infections in newborns and young infants, including neonatal sepsis—a major cause of infant mortality worldwide. This initiative comes in response to alarming statistics: 2.3 million newborns die every year, with around 15% of these deaths linked to sepsis. The burden is heaviest in low- and middle-income countries, where access to timely diagnosis and treatment remains limited.
Current diagnostic methods such as blood cultures and molecular diagnostics are often inaccessible, expensive, or unreliable, particularly in resource-limited settings. They suffer from low sensitivity, long turnaround times, and high infrastructure demands, making them poorly suited for the urgent needs of frontline healthcare facilities.
Lab Leaders See Shift in Global Standards
For laboratory leaders, WHO’s newly released target product profile for diagnosing serious bacterial infections in newborns and young infants could represent a pivotal shift in global diagnostic standards. As the demand for timely, accurate, and affordable diagnostic tools grows—particularly in low-resource settings—lab leaders have a unique opportunity to play a central role in shaping the next generation of in vitro diagnostics.
The new profile to is designed to define the essential and desirable characteristics of diagnostic tools needed to improve early detection of infections in infants aged 0–59 days. The profile covers two major clinical scenarios: use in primary health care settings and in higher-level hospitals. It’s intended to assist developers, regulators, and public health officials in designing effective tools tailored to diverse healthcare environments.
Yvan Hutin, MD, PhD, Director of the Department of Antimicrobial Resistance at WHO, emphasized the urgency of the effort, stating, “Timely and accurate diagnosis tests for serious bacterial infection is critical to reducing newborn mortality.”
Hutin’s areas of expertise include epidemiology, prevention, care and treatment of viral hepatitis, public health training, economic analyses, and financing. He has co-authored more than 120 articles in peer-reviewed journals. (Photo credit: WHO)
Silvia Bertagnolio, MD, Head of the Antimicrobial Resistance Surveillance, Evidence and Laboratory Strengthening Unit at WHO noted, “This new target product profile outlines the essential features needed in diagnostic tools to improve clinical decision-making, reduce unnecessary antibiotic use and prevent antimicrobial resistance, especially in low-resource settings where the burden of neonatal sepsis remains critical.”
Targeted Care
In many communities, healthcare workers must make critical decisions about antibiotic treatment or hospital referrals based on clinical judgment alone, without reliable diagnostics. The new tools envisioned by WHO would help identify which infants truly need antibiotics or hospitalization, allowing for more targeted and effective care.
The development of this target product profile was led by WHO’s Department of Antimicrobial Resistance, in collaboration with the Department of Maternal, Child Health and Ageing and the Research for Health Department. WHO also acknowledged the vital contributions of partners such as FIND and members of the target product development group, underscoring the collaborative nature of this global health effort.
For laboratory leaders, the release of this target product profile is more than just a technical guideline, it’s a call to action. By aligning their diagnostic development and evaluation efforts with WHO’s outlined priorities, lab leaders can help fill a critical gap in newborn and infant care, particularly in underserved regions. Their expertise will be essential in translating this profile into practical, scalable solutions that improve early detection, guide appropriate treatment, and ultimately save lives. As stewards of innovation and quality in diagnostics, lab leaders are uniquely positioned to drive meaningful progress in the global fight against neonatal infections and antimicrobial resistance.
—Janette Wider
