Title : Diagnosis of neonatal sepsis using a rapid lateral flow test to detect serum amyloid A.
Abstract:
Sepsis is a serious medical condition, and newborns in low- and middle-income countries (LMICs) are particularly vulnerable. Uganda has one of the highest rates of neonatal sepsis deaths in the world at 17 neonatal deaths per day. Such high mortality rates are largely due to the absence of suitable biomarkers and diagnostic systems to enable early diagnosis. However, serum amyloid A (SAA) is emerging as a potential standalone biomarker for the diagnosis of neonatal sepsis. SAA can be detected by laboratory-based tests but these are often unavailable in LMICs.
To address these issues, in an ethically-approved study we deployed a competitive, lateral flow test (NeoSep-SAATM; Accuplex Diagnostics Limited, Ireland) to semi-quantitatively detect SAA in whole blood at patient-side in a LMIC. Our study assessed the performance of NeoSep-SAATM for neonatal sepsis detection. NeoSep-SAATM showed a sensitivity and specificity of 92 % and 73 % with PPV and NPV of 0.78 and 0.90, respectively (n= 714) individuals; 95% CI). NeoSep-SAATM significantly out-performed the currently-available gold-standard biomarker, C-Reactive Protein, for neonatal sepsis detection (P < 0.0001, 95% CI). This study demonstrates NeoSep-SAATM can successfully detect sepsis and potentially enable a rapid decision to initiate antibiotic therapy to improve neonatal mortality incidence.
