Presepsin (Soluble {CD}14 Subtype) as an Early Marker of Neonatal Sepsis and Septic Shock: A Prospective Diagnostic Trial

In the context of suspected neonatal sepsis, early diagnosis and stratification of patientsaccording to clinical severity is not yet effectively achieved. In this diagnostic trial, we aimed toassess the accuracy of presepsin (PSEP) for the diagnosis and early stratification of supposedly septicneonates. PSEP, C-reactive protein (CRP), and procalcitonin (PCT) were assessed at the onset ofsepsis suspicion (T0), every 12–24 h for the first 48 h (T1–T4), and at the end of antibiotic therapy(T5). Enrolled neonates were stratified into three groups (infection, sepsis, septic shock) accordingto Wynn and Wong’s definitions. Sensitivity, specificity, and area under the ROC curve (AUC)according to the severity of clinical conditions were assessed. We enrolled 58 neonates with infection,77 with sepsis, and 24 with septic shock. PSEP levels were higher in neonates with septic shock(median 1557.5 pg/mL) and sepsis (median 1361 pg/mL) compared to those with infection (median977.5 pg/mL) at T0 (p< 0.01). Neither CRP nor PCT could distinguish the three groups at T0.PSEP’s AUC was 0.90 (95% CI: 0.854–0.943) for sepsis and 0.94 (95% CI: 0.885–0.988) for septicshock. Maximum Youden index was 1013 pg/mL (84.4% sensitivity, 88% specificity) for sepsis,and 971.5 pg/mL for septic shock (92% sensitivity, 86% specificity). However, differences in PSEPbetween neonates with positive and negative blood culture were limited. Thus, PSEP was an earlybiomarker of neonatal sepsis severity, but did not support the early identification of neonates withpositive blood culture.