Presepsin as a predictor of positive blood culture in suspected
Division of Neonatology,
Department of Paediatrics, Shinshu University School of Medicine, Matsumoto and
Neonatology, Nagano Children’s Hospital, Azumino, Nagano, Japan
Abstract Background: Although the incidence of neonatal sepsis is decreasing, neonatal sepsis remains a severe life-threa-
tening disease. No current biochemical marker can provide perfect diagnostic accuracy for neonatal sepsis. The aim
of this study was therefore to evaluate the accuracy of presepsin (P-SEP) as a novel biomarker of bacterial infection
for neonatal sepsis diagnosis.
Methods: We prospectively studied newborns with sepsis (sepsis group; n = 13) during the ﬁrst 30 days after birth
and compared them with control preterm newborns (control group; n = 18). In addition, we evaluated term new-
borns with some clinical signs of early onset sepsis (non-sepsis term group; n = 35).
Results: P-SEP in the sepsis group was signiﬁcantly higher than in the control group (P < 0.001) The area under
the curve for P-SEP was 0.868 (95%CI: 0.71–1.00). A P-SEP cut-off of 795 pg/mL was established, with 85% sen-
sitivity and 89% speciﬁcity. The positive and negative predictive values were 85% and 89%, respectively. In the
non-sepsis term group, P-SEP had better stability than white blood cells and C-reactive protein for 3 days after
Conclusions: P-SEP can better discriminate between infections and non-infectious inﬂammatory conditions than
the currently used biomarkers.
Key words newborn, presepsin, sepsis.
Neonatal sepsis is the most common cause of morbidity and
mortality during the neonatal period. Neonatal sepsis is classi-
ﬁed as either early-onset sepsis (EOS; ≤7 days after birth) or
late-onset sepsis (LOS; >7 days after birth).
obstetric and neonatal care have decreased the incidence of
neonatal sepsis, especially EOS. Currently, the incidence of
group B Streptococcus-speciﬁc EOS has declined to 0.3–0.4
cases/1,000 live births, and overall the EOS incidence has
declined to 0.8–1.0 cases/1,000 live births. Nevertheless, EOS
remains a severe life-threatening disease with a mortality rate
ranging from 1.5% in term infants to almost 40% in very low-
Early diagnosis and treatment of neona-
tal sepsis are important to prevent severe complications. In
this era of multi-resistant microorganisms, however, it is also
important to avoid the unnecessary use of antibiotics in sepsis-
negative infants. On the basis of the Centers for Disease Con-
trol and Prevention 2010 guidelines, Escobar et al. reported
that, in a cohort of 7,004 infants, 13% of both well-appearing
and ill-appearing infants were evaluated for EOS, and 11%
were treated empirically with antibiotics, although only 0.04%
of the cohort had blood culture-conﬁrmed infection.
has arisen regarding the EOS results and the empirical antibi-
otic treatment of hundreds of thousands of uninfected new-
borns annually, resulting in maternal–infant separation and
signiﬁcant expenditure. In treating this low-incidence but
highly consequential disease, clinicians seek the early identiﬁ-
cation of infants with EOS, with the goal of identifying those
at risk and facilitating antibiotic treatment to prevent progres-
sion to severe disease.
Blood culture is the gold standard for the diagnosis of sepsis
in newborns, but the long waiting time for results and the high
level of false-negatives that are secondary to the small volume
of blood used, make it difﬁcult to use blood culture in the antibi-
otic treatment decision-making process at the beginning of the
Hence, antibiotics are often started empiri-
cally in infants with perinatal risk factors or clinical signs sug-
gestive of a bacterial infection. Therefore, various biochemical
markers are used to aid decision making regarding antibiotic
therapy in neonatal sepsis.
Nevertheless, no current biochemi-
cal marker can provide perfect diagnostic accuracy.
Presepsin (P-SEP), or soluble CD14 subtype, is a truncated
variant of soluble CD14, and pathogens stimulate P-SEP
Correspondence: Tomohiko Nakamura, MD PhD, Division of
Neonatology, Nagano Children’s Hospital, 3100 Toyoshina, Azu-
mino City, Nagano 399-8288, Japan.
Received 22 March 2017; revised 5 November 2017; accepted
30 November 2017.
© 2017 Japan Pediatric Society
Pediatrics International (2018) 60, 157–161 doi: 10.1111/ped.13469