Abstract / Summary
Abstract Objective This study aimed to evaluate the diagnostic value of presepsin (P-SEP) in both umbilical cord and peripheral blood for neonatal early-onset sepsis (EOS), compare its efficacy with conventional biomarkers, and establish optimal diagnostic thresholds. Study design Prospective cohort study of 355 neonates with EOS risk factors recruited from Peking University Shenzhen Hospital (June 2024-March 2026). Following stratification into EOS (n=95) and non-EOS groups (n=260), we measured P-SEP, complete blood count(CBC), C-reactive protein (CRP), procalcitonin (PCT), and interleukin-6 (IL-6) in umbilical cord (n=195) and peripheral blood samples (n=338) collected within 72 hours postpartum. Diagnostic performance was assessed through ROC curve analysis and biomarker comparisons. Results P-SEP concentrations were significantly elevated in EOS cases of both sample types (p<0.001). In this prospective study, we enrolled 355 neonates (95 with EOS and 260 controls). Successful umbilical cord blood collection was achieved in 195 cases (50 EOS, 145 controls), while peripheral blood samples were obtained from 338 neonates (95 EOS, 243 controls). Our findings demonstrate significantly elevated P-SEP levels in both blood types of EOS patients compared to controls (both p<0.001). ROC curve analysis established optimal diagnostic thresholds at 762.96 pg/mL for umbilical cord blood (sensitivity(Se) 94%, specificity(Sp) 77.2%, the area under the curve(AUC)0.937) and 752.7 pg/mL for peripheral blood (Se 78.6%, Sp 95.6%, AUC 0.935). Notably, P-SEP demonstrated superior diagnostic accuracy versus traditional biomarkers (p<0.001). Temporal analysis revealed P-SEP's remarkable stability - maintaining diagnostic reliability for 72 hours in controls and 24 hours in EOS cases. Conclusion P-SEP is a highly effective biomarker for EOS diagnosis in neonates, demonstrating superior accuracy over conventional tests. Umbilical cord blood P-SEP levels are consistently higher than peripheral samples. Moreover, peripheral blood P-SEP remains stable for 72 hours in healthy newborns and 24 hours in EOS cases, ensuring a reliable window for timely clinical intervention.