Diagnostic Accuracy of Soluble CD14 (Presepsin) in Identifying Gram- Positive versus Gram-Negative Infections in Preterm Neonates with Early-Onset Sepsis

Background Identifying the type of bacterial infection in a timely manner is crucial for the successful treatment of newborns with sepsis. Because blood culture results are often delayed, early biomarkers are needed to promptly signal infection and potentially provide clues to differentiate between Gram-positive and Gram-negative infections, thereby guiding timely therapy. Presepsin (P-SEP) has recently gained attention as a promising biomarker, generated as a component of the immune system's reaction to bacterial infection. It acts as an early warning sign of sepsis in newborns and can be identified in the first phases of inflammation. Purpose To assess the accuracy of soluble CD14 (presepsin) in differentiating between Gram-positive and Gram-negative infections in preterm newborns with early-onset neonatal sepsis. Methods sixteen newborns with early-onset sepsis proven retrospectively by positive blood culture results were included in this prospective observational study. Serum presepsin levels were measured at day 1 and day 3 after diagnosis. Results Patients with gram-negative infections had significantly elevated P-SEP levels initially on the first day and at follow-up on the third day. At a cutoff value of ≥ 970 ng/L, serum P-SEP on day 3 yielded a 100% positive predictive value, an 87.5% sensitivity, a 100% specificity, and an 88.8% negative predictive value to accurately predict the presence of gram negative bacterial infection. Conclusion Presepsin is a useful early biomarker in preterm neonates with early-onset sepsis, showing good accuracy in differentiating Gram-positive from Gram-negative infections and supporting timely clinical decision-making. Clinical trial number: not applicable