WHO Issues New Neonatal Sepsis Diagnostics Guidance – Understanding the Urgency
The World Health Organization (WHO) has released a new Target Product Profile (TPP) to guide the development of in vitro diagnostic tests for serious bacterial infections in infants aged 0–59 days, including neonatal sepsis, which accounts for 15% of newborn deaths globally.
Key insights from the WHO report:
- 2.3 million newborns die annually, mostly in low- and middle-income countries.
- 84% of infection-related deaths could be prevented with early diagnosis and appropriate treatment.
- Current diagnostics (e.g., blood cultures, molecular tests) can be slow, expensive, and impractical in many settings.
WHO calls for rapid, low-volume, point-of-care tests that can be used in both hospital and primary care environments. Biomarkers like CRP and Procalcitonin are highlighted as part of hospital-based diagnostic algorithms, but they are not yet widely accessible or validated for use in all settings.
Why This Matters for Diagnostic Developers working in Neonatal Sepsis Testing
The WHO TPP outlines both essential and desirable characteristics for new tests, essential characteristics include:
- High sensitivity (≥90%) and specificity (≥70–80%)
- Fast turnaround time (≤30 minutes)
- Low hands-on time (<10 minutes)
- Use of low blood volumes (≤100μL)
These criteria are designed to support clinical decision-making, reduce unnecessary antibiotic use, and help prevent antimicrobial resistance.
Supporting Innovation in Sepsis Diagnostics
At BBI, we provide validated antibodies and antigens for key inflammatory markers, including CRP and IL-6 antibodies:
Developed to the highest quality standards under ISO13485, and with immunoassay performance including Lateral Flow for assurance in point-of-care application testing.
For more bespoke, innovative needs, our decades of antibody development expertise can help. Our mission is to help support diagnostic developers and researchers globally in working for better health outcomes.
📚 Read the WHO TPP Guidance: In vitro diagnostic tests for serious bacterial infection, including neonatal sepsis, among infants aged 0–59 days: target product profile
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