Neonatal sepsis still remains a major cause of morbidity and mortality in neonatal intensive care unit (NICU). Recently,
soluble CD14 subtype (sDC14-ST) also named presepsin, was proposed as an effective
biomarker for diagnosing, monitoring, and assessing the risk of
neonatal sepsis and
septic shock. The aim of this study was to investigate the diagnostic accuracy of sCD14-ST presepsin in diagnosing neonatal bacterial
sepsis and in discriminating non-bacterial
systemic inflammatory response syndrome (SIRS) from bacterial
sepsis. This study involved 65
critically ill full-term and preterm newborns admitted to the neonatal intensive care unit (NICU), divided into three groups: 25 newborns with bacterial
neonatal sepsis (group A); 15 newborns with a diagnosis of non-bacterial SIRS and with no localizing source of
bacterial infection (group B); and 25 babies with no clinical or bacteriological signs of systemic or local
infection receiving routine NICU care, most of them treated with
phototherapy for
neonatal jaundice (group C). A total of 102 whole blood samples were collected, 40 in group A, 30 in group B and 32 in group C. In 10 babies included in group A, sCD14-ST presepsin was also measured in an additional second blood sample collected 3 days after the start of
antibiotic treatment. sCD14-ST presepsin was measured by a commercially available chemiluminescent
enzyme immunoassay (CLEIA) optimized on an automated immunoassay analyzer. Statistical analysis was performed by means of MedCalc® statistical package; receiver operating characteristic (ROC) analysis was computed, and the area under the ROC curve (AUC) was used to evaluate the ability of sCD14-ST to discriminate neonatal bacterial
sepsis from non-bacterial SIRS. Blood sCD14-ST presepsin levels were found significantly higher in bacterial
sepsis when compared with controls (p<0.0001); similarly, they were higher in non-bacterial SIRS when compared with controls (p<0.0001). However, no statistically significant difference was found between bacterial
sepsis and non-bacterial SIRS (p=0.730). In our population, CRP and sCD14-ST did not correlate with each other. ROC analysis revealed that sCD14-ST presepsin has an area under the curve (AUC) of 0.995 (95% C.I.: 0.941-1.00) greater than that of CRP (0.827; 95% C.I.: 0.72-0.906). Similarly, in the group of babies with non-infectious SIRS, sCD14-ST AUC was greater than CRP AUC (0.979; 95% C.I.: 0.906-0.999 versus 0.771; 95% C.I.: 0.647-0.868). In controls, preliminary reference intervals for sCD14-ST ranged 223.4-599.7 ng/L, being significantly different from those previously published elsewhere. In conclusion, sCD14-ST presepsin could be introduced in clinical practice as a diagnostic tool for improving the management of
neonatal sepsis and non-bacterial SIRS.