Aligning neonatal sepsis triage diagnostics with WHO target product profiles in low- and middle-income countries

Neonatal sepsis is a leading cause of infant morbidity and mortality in low- and middle-income countries (LMICs), yet despite this, progress in the development and implementation of effective diagnostics has been limited. Current diagnostic methods rely on clinical assessments of nonspecific signs and symptoms, limited laboratory testing and technologies that are inaccessible, unaffordable or unsuitable for resource-constrained settings. There is an urgent need for reliable, affordable and context-appropriate point-of-care diagnostics. This analysis synthesises evidence across current and emerging diagnostic strategies for neonatal sepsis, including clinical algorithms, host-response biomarkers, haematological parameters, continuous monitoring and artificial intelligence-based digital platforms. We assess their performance, operational feasibility in LMICs and alignment with the WHO Target Product Profile (TPP) for neonatal sepsis, including requirements for highly sensitive triage, feasibility in non-hospital settings and suitability for use at the point of care in LMICs. We identified promising existing technologies and emerging approaches that could be used to address the challenges of diagnosing neonatal sepsis in LMICs. These include host-response biomarkers that offer greater accuracy than those currently used, as well as affordable technologies that can improve current predictive algorithms. Taken together, these findings support a move towards integrated, TPP-aligned diagnostic strategies that combine affordable point-of-care testing, routine clinical data and digital decision support to improve early detection, rationalise antibiotic use and reduce neonatal mortality

Clinical decision support system · Diagnostic test · Neonatal sepsis · Point of care · Point-of-care testing · Sepsis · Triage · Bacterial Identification and Susceptibility Testing · Neonatal and Maternal Infections · Sepsis Diagnosis and Treatment

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