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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.