Presepsin Accurately Detects Early-Onset Sepsis in Preterm Neonates

Compared with pro-calcitonin and C-reactive protein, presepsin has better diagnostic accuracy in discriminating early-onset sepsis.

When compared with pro-calcitonin (PCT) and C-reactive protein (CRP), presepsin (P-SEP) showed better diagnostic accuracy in detecting early-onset sepsis in preterm neonates, according to a study published in Pediatric Research.

Dr Paolo Montaldo, from the department of neonatal intensive care at Monaldi Hospital in Naples, Italy, and colleagues conducted a case-matched control study in their level 3 neonatal intensive care unit (NICU) between January 2013 and March 2016.  All preterm newborns (<34 weeks gestational age) admitted to the NICU by 6 hours of age and undergoing sepsis evaluation were included in the study.

Neonates were divided into 2 groups: an early-onset sepsis group (n = 32) and an uninfected group (n = 38). Blood samples were collected to measure P-SEP, PCT, and CRP at the time of admission and then at 12, 24, and 48 hours of age. Exclusion criteria included  major congenital malformations, fetal hydrops, confirmed intrauterine infection, and lack of parental consent. The uninfected group was retrospectively matched with the early-onset sepsis group according to gestational age and birth weight.

Infection was defined as sepsis by 2 clinicians unaware of P-SEP measurement and included as septic or uninfected samples only if both clinicians agreed. In a similar manner, the treating physicians were blinded to the P-SEP results. All patients with early-onset sepsis were treated with antibiotics for 10 consecutive days. Antibiotic therapy was stopped after 2 days of treatment if bacterial cultures remained negative, CRP remained low, and the patient was clinically stable.

Compared with the uninfected group, the early-onset sepsis group had a higher rate of invasive ventilation (P =.001), clinical chorioamnionitis (P =.01), and death (P =.03), as well as a greater need for surfactant (P <.001) and inotropic support (P <.001) over the first 2 days of life.

PCT and CRP were significantly higher in the early-onset group when compared with the uninfected group at 12, 24, and 48 hours (P <.05) but not at the time of admission. P-SEP values, however, were significantly higher at all time points, “suggesting its potential utility in the early diagnosis of sepsis,” observed the researchers (see Table).

Table. Median Interquartile Range Using P-SEP (ng/L) Values

Time, h

Early-Onset Sepsis Group

Uninfected Group

P Value

0 (admission)

598 (457 – 787)

328 (311 – 527)



802 (511 – 1005)

385 (280 – 587)



1,228 (738 – 1546)

504 (212 – 646)



979 (588 – 1031)

476 (227 – 602)


Furthermore, using receiver operating characteristic (ROC) curve analysis, Dr Montaldo and colleagues showed that P-SEP had “better diagnostic accuracy in discriminating bacterial sepsis from [the] control [group] when compared with CRP and PCT.” The best accuracy for predicting sepsis was 24 hours after birth at the cut-off of 788 ng/L (area under the curve [AUC] 0.97; 95% CI, 0.94-1.00) with 93% sensitivity (95% CI, 82% to 98%) and 100% specificity (95% CI, 83% to 100%).

The researchers did note that CRP has a good negative predictive value and that it can be a used as a tool to support discontinuation of antibiotic therapy, as suggested by the American Academy of Pediatrics.

Due to nonspecific signs and symptoms, diagnosing neonatal sepsis continues to be extremely challenging.  As a consequence, “identification of rapid diagnostic biomarkers of sepsis to differentiate septic from uninfected neonates is a major priority in neonatal research.” P-SEP appears to be a promising biomarker of early-onset sepsis. However, the investigators concluded that due to the small sample size of this study, larger studies are required to confirm this finding.

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Montaldo P, Rosso R, Santantonio A, Chello G, Giliberti P. Presepsin for the detection of early-onset sepsis in preterm newborns [published online December 7, 2016]. Pediatr Res. doi: 10.1038/pr.2016.217