Potential Health and Cost Impacts of a Point-of-Care Test for Neonatal Sepsis and Possible Serious Bacterial Infections in Infants: A Modeling Analysis in Two Settings.

Background: Sepsis contributes to nearly 50% of neonatal deaths in resource-limited settings. Accurate, timely diagnosis can improve outcomes, reduce inappropriate antibiotic use, and save healthcare costs. We aimed to determine the minimum technical requirements and cost of a point-of-care test (POCT) for neonatal sepsis to be clinically effective in hospitals and community settings in low-resource settings. Methods: We modeled the diagnosis and treatment of hospitalized neonates and infants at primary care facilities with suspected sepsis. Health outcomes (mortality, hospital stays, and healthcare-associated infections [HAIs]) were compared under empiric treatment with varied blood culture scenarios to a POCT. Test performance, bacterial infection prevalence, and discharge criteria were varied. A threshold economic analysis identified maximum allowable costs for a cost-neutral POCT. Results: A POCT could reduce neonatal deaths significantly at hospitals (up to 19%) and community levels (up to 70%), compared with baseline, by enabling faster therapy initiation and reducing unnecessary hospitalizations and HAIs. Healthcare costs could drop by 17%-43% in hospitals and 48%-81% in primary care settings. A POCT priced at $21 for hospitals and $3 for community use could remain cost-neutral. Conclusions: A POCT for neonatal sepsis, even with moderate accuracy, could improve outcomes by accelerating diagnosis, supporting antibiotic stewardship, and lowering costs. High sensitivity is essential to minimize deaths from missed diagnoses and delayed antibiotic therapy. Our results suggest 85% sensitivity and 80% specificity for hospitalized neonates, and 90% sensitivity and 70% specificity in primary care settings are the minimum necessary technical requirements for the POCT.