Presepsin for the Detection of Late-Onset Sepsis in Preterm Newborns

BACKGROUND: Late-onset sepsis (LOS) is among the leading causes of morbidity and mortality in preterm newborns, and currently available diagnostic tools are inadequate. The objective of this study was to evaluate the accuracy of presepsin (P-SEP) as novel biomarker of bacterial infection for the diagnosis of LOS in preterm newborns. METHODS: We prospectively studied newborns <= 32 weeks' gestational age with LOS (n = 19) and noninfected controls (n = 21) at 4 to 60 days' postnatal age. At enrollment, and 1, 3, and 5 days later, we ascertained the C-reactive protein, procalcitonin, and P-SEP in the LOS group, whereas P-SEP alone was ascertained in the control group. RESULTS: P-SEP at enrollment was higher in the LOS than the control group (median 1295 vs 562 ng/L, P = .00001) and remained higher throughout the study period. In the LOS group, P-SEP had a borderline reduction at day 1 versus values at enrollment (median 1011 vs 1295 ng/L, P = .05), whereas C-reactive protein and procalcitonin at day 1 did not differ from baseline values. The receiver operating characteristic curve of P-SEP at enrollment shows an area under the curve of 0.972. The best calculated cutoff value was 885 ng/L, with 94% sensitivity and 100% specificity. Negative likelihood ratio was 0.05, and positive likelihood ratio was infinity. CONCLUSIONS: We demonstrated for the first time in a cohort of preterm newborns that P-SEP is an accurate biomarker for the diagnosis of possible LOS and may also provide useful information for monitoring the response to therapeutic interventions.