The World Health Organization (WHO) has released a new Target Product Profile (TPP) on August 6, 2025.
This new guidance is designed to enhance early detection of serious bacterial infections in young infants.
It focuses on children aged 0 to 59 days, a critical age group for infections. The TPP aims to help develop better in vitro diagnostic tests for newborn care globally.
Currently, diagnostic options for sepsis and related infections in infants are limited and often delayed.
Many existing tests depend on blood cultures or molecular platforms requiring advanced infrastructure.
These methods are costly, slow, and unsuitable for low-resource settings, especially in rural regions.
The new TPP recommends tests that offer quick results without needing complex laboratory systems.
One of the major goals is to guide antibiotic use more precisely in early-stage infections.
Accurate detection can reduce unnecessary antibiotic prescriptions and limit antimicrobial resistance risks.
WHO emphasizes the importance of using such diagnostics at both primary and referral-level health centers.
Early intervention improves outcomes and saves lives when serious bacterial infections are detected on time.
The TPP outlines technical specifications including sensitivity, turnaround time, and minimal sample volume requirements.
It also defines operational features such as power independence and device portability for remote locations.
Test results should be available within one hour to support rapid clinical decisions.
This is especially crucial in countries with limited access to trained healthcare professionals or laboratories.
The guidance was developed by WHO’s AMR and maternal health teams in collaboration with global partners.
FIND, a non-profit focused on diagnostics, also contributed to technical recommendations in the profile.
This initiative aligns with global efforts to improve newborn health and lower mortality rates.
With better diagnostics, infants in under-resourced regions can receive timely, life-saving treatments.
By setting these new standards, WHO hopes to inspire innovation in molecular diagnostic development.
The TPP may encourage industry players to prioritize affordable, scalable, and accessible test designs.
This move marks a significant step toward equity in infant healthcare across all income levels.
