Low- and middle-income countries (LMICs) bear the greatest burden of neonatal mortality, with sepsis being a major contributor.
Non-specificity of signs, and the absence of a definitive diagnostic, present a challenge to the identification of sepsis and can lead to underdiagnosis or overdiagnosis, both of which can have harmful consequences.
As early intervention can be life-saving, sepsis protocols, which commonly include empiric therapies, result in the overuse of antibiotics and the development of antimicrobial resistance.
Affordable and accurate diagnostic tests that can detect neonatal sepsis at or near the point of care could contribute to reduced sepsis-related mortality in LMICs and support antimicrobial stewardship.
A screening test to guide referral to hospital from primary care, and an in-hospital test to guide treatment decisions, are high priorities.
Considerable investment will be needed to support the development of these diagnostics.
