Cost-Effectiveness of a Target Point-of-Care Triage Test for Neonatal Sepsis in Low- and Middle-Income Countries

Neonatal sepsis is a leading cause of mortality in low- and middle-income countries (LMICs). The current diagnostic standard, blood culture, has long turnaround times and high infrastructure requirements, limiting its utility. Consequently, clinicians rely on non-specific clinical signs for initial management. To address this unmet need, the WHO published a 2025 Target Product Profile (TPP) for rapid point-of-care tests (POCTs). We developed a global expert-validated model to estimate the cost-effectiveness of a TPP-compliant POCT in LMICs. A decision tree compared a TPP-compliant POCT integrated into standard of care (SOC) against SOC alone from a healthcare system perspective over a lifetime horizon. The model evaluated infants (0–59 days) with possible serious bacterial infection across facility-of-birth and community-presenting cohorts. Outcomes included incremental cost per disability-adjusted life-year (DALY) averted. Probabilistic and threshold sensitivity analyses assessed parameter uncertainty. At a US$ 5·00 unit price, the POCT reduced costs by US$ 37 342 and averted 206 DALYs per 1 000 facility-of-birth patients compared to SOC. In community-presenting patients, it reduced costs by US$ 5 715 and averted 127 DALYs per 1 000. The POCT was dominant in 93·2% (facility) and 84·8% (community) of probabilistic iterations. Results remained robust across wide-ranging epidemiological and cost inputs. These findings provide an evidence base supporting prioritised investment in developing a TPP-compliant POCT to improve neonatal sepsis management in LMICs.