Presepsin (Soluble CD 14 Subtype) in Term and Preterm Newborns: Preliminary Reference Ranges and Usefulness in the Diagnosis of Sepsis

[4146.354]] BACKGROUND: Sepsis is a major cause of morbidity and mortality in newborns. Recently, presepsin (soluble CD14subtype, sCD14-ST) has been shown to be beneficial as sepsis marker in adults. Nevertheless, few data are availablein newborns.OBJECTIVE: To determine: 1) the reference ranges for presepsin in healthy term newborns 2) the reference rangesfor presepsin in preterm newborns without clinical signs of sepsis 3) the diagnostic accuracy of presepsin as a markerof sepsis in newborns.DESIGN/METHODS: All infants admitted to our Unit during a 18-months period are enrolled into 3 groups: 1) healthyterm newborns 2) preterm newborns without clinical signs of sepsis 3) term and preterm newborns with clinical signsof sepsis. To measure presepsin, 100 microliters of blood are collected on day 3 of life in newborns of group 1 and 2and at the following times in newborns of group 3: at the onset of clinical signs of sepsis (T0), every 12 h for the next48 h (T1, T2, T3, T4), and at the end of antibiotic therapy (T5). C-reactive protein (CRP) is determined at the sametimes. Presepsin levels are determined using Pathfast® Immunoanalyzer (Mitsubishi Chemical Medience Corporation;Gepa Diagnostics).RESULTS: Until now, we enrolled 487 newborns in group 1 (mean GA 38.9 wks, mean BW 3211 g), 168 in group 2(mean GA 33.9 wks, mean BW 2052 g) and 42 in group 3 (mean GA 32.4 wks, mean BW 1811 g). Mean presepsinvalue was 650.2 pg/ml (SD 258.2; Median 603.5, Q1-Q3 468 – 794) in group 1 and 722.3 pg/ml (SD 339.4; Median636, Q1-Q3 506 – 862) in group 2. GA, gender, ethnicity, mode of delivery, SGA, twin, maternal fever, and stainedamniotic fluid did not affect presepsin levels. In group 3, mean presepsin value was 1087,5 pg/ml at T0 anddecreased over time to 743 pg/ml at T5. 14/42 neonates in group 3 had a positive blood culture, 26 had a negativeblood culture. Presepsin values were higher in infants with proven sepsis than in the others at T0, 1, 2, 3 and 4 (p <.01). CRP values were higher in infants with proven sepsis than in the others only from T2.CONCLUSIONS: Reference ranges for presepsin, determined for the first time in a large sample of healthy term andpreterm newborns, are much higher than in adults. Presepsin seems to be an accurate and early biomarker for thediagnosis of neonatal sepsis.