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The Pathologist / Issues / 2025 / Aug / Mapping Out Standards for Newborn Sepsis Diagnostics / Notecards
Infectious Disease Screening and monitoring Molecular Pathology

Mapping Out Standards for Newborn Sepsis Diagnostics

Target product profile highlights priority settings and performance needs for newborn diagnostic tests

08/22/2025 News 2 min read
article Full Article Summary Notecard

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  1. WHO released a target product profile for IVD tests.

  2. Focuses on neonatal sepsis detection.

  3. Aims to reduce infant mortality worldwide.

  4. Sepsis causes ~15 percent of newborn deaths.

  5. Current diagnostics face challenges like sensitivity and cost.

  6. Effective tests should improve clinical decision-making.

  7. Profile tailored for low-resource settings.

  8. Developed with input from various health departments and organizations.

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