Usage of procalcitonin and sCD14-ST as diagnostic markers for postoperative spinal infection.

OBJECTIVE: Identifying biomarkers for early diagnosis of postoperative spinal infection is essential to avoid complications after spine surgery. The presented study evaluated serum levels of procalcitonin (PCT), C-reactive protein (CRP), and soluble CD14 subtype (sCD14-ST) in patients who underwent spinal surgery to assess the diagnosis values of PCT and sCD14-ST. METHODS: Serum levels of PCT, CRP, and sCD14-ST were measured in 490 (289 male/201 female) patients who underwent spinal surgery (SS) before and 1 day after surgery. PCT and sCD14-ST levels of patients diagnosed with postoperative infection (PI) and patients diagnosed with postoperative non-infection (PN) were compared. RESULTS: Serum levels of PCT, CRP, and sCD14-ST were significantly increased after surgery (F = 58.393, P = 0.000). In patients diagnosed as having a PI, serum levels of PCT and sCD14-ST were positively correlated with each other (r = 0.90, P < 0.01) and with operation duration (r = 0.92, 0.88, P < 0.01). Receiver operating characteristic (ROC) models showed that both PCT (AUC = 0.817, optimal cutoff: 0.69 ng/ml, P = 0.000) and sCD14-ST (AUC = 0.824, optimal cutoff: 258.27 pg/ml, P = 0.000) can distinguish PI versus PN patients well. CONCLUSION: Our results demonstrated that serum levels of PCT and sCD14-ST have the potential to be used as a diagnostic markers for postoperative spinal infection.

Soluble CD14 subtype (sCD14-ST) as biomarker in neonatal early-onset sepsis and late-onset sepsis: a systematic review and meta-analysis.

BACKGROUND: Early diagnosis of bacterial sepsis in neonates is hampered by non-specific symptoms and the lack of rapid responding laboratory measures. The biomarker soluble CD14 subtype (sCD14-ST) seems promising in the diagnostic process of neonatal sepsis. In order to evaluate the differences in diagnostic accuracy of sCD14-ST between early onset sepsis (EOS) and late onset sepsis (LOS) we assessed this systematic review and meta-analysis. RESULTS: Twelve articles were included in the systematic review and 10 in the meta-analysis. There was a high risk of bias on patient selection, index test and/or flow and timing. The overall quality of the included studies was moderate. At sepsis onset a consequently higher level of sCD14-ST was found in septic neonates compared to healthy controls with significant higher levels in LOS compared to EOS. In the first 24 h after sepsis onset a significant increase in pooled means of plasma sCD14-ST levels was seen in EOS (t(71.6) = 7.3, p < .0001) while this was not seen in LOS or healthy controls. Optimal cut-off values ranged from 305 to 672 ng/l for EOS cases versus healthy controls. The pooled sensitivity was 81% (95%CI: 0.76-0.85), the pooled specificity was 86% (0.81-0.89) with an AUC of 0.9412 (SE 0.1178). In LOS optimal cut-off values ranged from 801 to 885 ng/l with a pooled sensitivity of 81% (0.74-0.86) and a pooled specificity of 100% (0.98-1.00). An AUC and SROC was not estimable in LOS because of the low number of studies. CONCLUSIONS: sCD14-ST is a promising and rapid-responding diagnostic biomarker for EOS and LOS. The difference in pooled means between EOS and LOS underlines the importance to consider EOS and LOS as two different disease entities, requiring separate analysis in original articles and systematic reviews.

Diagnostic value of levels of presepsin (soluble CD14-subtype) in febrile neutropenia in patients with hematological disorders.

BACKGROUND: Whether presepsin (soluble CD14-subtype) is better than other markers including procalcitonin (PCT), has not been adequately investigated in febrile neutropenia (FN). METHODS: We prospectively examined the utility of presepsin in FN in Cohort 1 (C1) and 2 (C2), between November 2010 and February 2012, and between November 2013 and January 2014, respectively. The purpose of this study was to investigate 1) the relative value of serum presepsin over serum PCT in C1, and 2) the relative value of plasma presepsin as compared with serum PCT, C-reactive protein, interleukin-6 and interleukin-8 with frequent, repeated sampling in C2. RESULTS: Seventy-nine FN episodes (C1, 75; C2, 4) were evaluable. In C1, when compared with control values, presepsin was significantly higher at onset of FN (P = 0.004), while PCT was not significantly higher (P = 0.54). The median value of serum presepsin within 72 h of onset of FN in subjects with fever of unknown origin, local infection, bacteremia and septic shock was 680 (reference 314) pg/ml, 763, 782 and 1359, respectively. In C2, the mean levels of plasma presepsin from onset of FN to 72 h were classified as negative in the two patients with no suspected site of infection, and those of the remaining two patients with clinically probable infections were positive (175, 131, 346 and 329 pg/ml, respectively). In contrast, the other markers did not discriminate between this two groups. CONCLUSIONS: In FN, presepsin may be an earlier and more sensitive indicator of bacterial infection than PCT.

Perioperative presepsin as a potential early predictor for postoperative infectious complications in cardiac surgery.

INTRODUCTION: Postoperative infection remains a serious complication of cardiac surgery; however, no existing biomarkers can detect infection in the early perioperative period. We investigated the usefulness of presepsin, a novel biomarker, in predicting postoperative infectious complications in cardiac surgery with cardiopulmonary bypass. MATERIAL AND METHODS: For patients aged > 18 years who underwent elective cardiac surgery with cardiopulmonary bypass between 2015 and 2017, data of clinical features, perioperative presepsin levels, and infectious complications were collected. We compared the perioperative presepsin levels between the infected and non-infected groups, performed a risk factor analysis for postoperative infection, and calculated the cut-off value of presepsin with postoperative infection. RESULTS: Among the 73 included patients, 20 developed postoperative infectious complications. The presepsin levels pre-operatively and on post-operative day (POD) zero were significantly higher in the infected than in the non-infected group (145.2 vs. 93.2, 514.0 vs. 328.1 [pg mL-1], p < 0.05, respectively). The odds ratio (OR) for postoperative infection included pre-operative presepsin (OR; 1.22 [confidence interval; 1.07-1.40]/10 pg mL-1) and presepsin on POD zero (OR; 1.31 [confidence interval; 1.05-1.64] /100 pg mL-1). The cut-off predictive values for postoperative infectious complications of pre-operative presepsin and on POD zero were 132 and 347 [pg mL-1], respectively. CONCLUSIONS: Perioperative presepsin levels could be an early predictor for postoperative infectious complications in cardiac surgery.

Plasma Soluble CD14 Subtype Levels Are Associated With Clinical Outcomes in Critically Ill Subjects With Coronavirus Disease 2019.

IMPORTANCE: In bacterial sepsis, CD14 and its N-terminal fragment (soluble CD14 subtype, "Presepsin") have been characterized as markers of innate immune responses and emerging evidence has linked both to coronavirus disease 2019 pathophysiology. OBJECTIVES: Our aim was to determine the relationship between the soluble form of CD14 and soluble CD14 subtype plasma levels, coronavirus disease 2019 status, and coronavirus disease 2019-related outcomes. DESIGN: A prospective cohort study. SETTING: ICUs in three tertiary hospitals in Seattle, WA. PARTICIPANTS: Two-hundred four critically ill patients under investigation for coronavirus disease 2019. MAIN OUTCOMES AND MEASURES: We measured plasma soluble CD14 and soluble CD14 subtype levels in samples collected upon admission. We tested for associations between biomarker levels and coronavirus disease 2019 status. We stratified by coronavirus disease 2019 status and tested for associations between biomarker levels and outcomes. RESULTS: Among 204 patients, 102 patients had coronavirus disease 2019 and 102 patients did not. In both groups, the most common ICU admission diagnosis was respiratory failure or pneumonia and proportions receiving respiratory support at admission were similar. In regression analyses adjusting for age, sex, race/ethnicity, steroid therapy, comorbidities, and severity of illness, soluble CD14 subtype was 54% lower in coronavirus disease 2019 than noncoronavirus disease 2019 patients (fold difference, 0.46; 95% CI, 0.28-0.77; p = 0.003). In contrast to soluble CD14 subtype, soluble CD14 levels did not differ between coronavirus disease 2019 and noncoronavirus disease 2019 patients. In both coronavirus disease 2019 and noncoronavirus disease 2019, in analyses adjusting for age, sex, race/ethnicity, steroid therapy, and comorbidities, higher soluble CD14 subtype levels were associated with death (coronavirus disease 2019: adjusted relative risk, 1.21; 95% CI, 1.06-1.39; p = 0.006 and noncoronavirus disease 2019: adjusted relative risk, 1.19; 95% CI, 1.03-1.38; p = 0.017), shock, and fewer ventilator-free days. In coronavirus disease 2019 only, an increase in soluble CD14 subtype was associated with severe acute kidney injury (adjusted relative risk, 1.23; 95% CI, 1.05-1.44; p = 0.013). CONCLUSIONS: Higher plasma soluble CD14 subtype is associated with worse clinical outcomes in critically ill patients irrespective of coronavirus disease 2019 status though soluble CD14 subtype levels were lower in coronavirus disease 2019 patients than noncoronavirus disease 2019 patients. Soluble CD14 subtype levels may have prognostic utility in coronavirus disease 2019.

Effect of Intravenous IgM-Enriched Immunoglobulins on Presepsin and Other Sepsis Biomarkers.

Patients in septic shock with low IgG and IgM serum concentrations have higher mortality rates compared to those with normal immunoglobulin levels and, therefore, there is a rational explanation to administer intravenous IgM-enriched immunoglobulins to septic patients in ICU. Aim of this study is to evaluate the effectiveness of intravenous IgM-enriched immunoglobulins in decreasing several sepsis biomarker concentrations. 26 sepsis patients were enrolled in this observational cohort study and Nitric Oxide, Endocan, Pentraxin and presepsin serum levels were measured during their first 3 days of ICU stay. The use of intravenous IgM-enriched immunoglobulins did not influence the temporal evolution of SOFA, Nitric Oxide, Endocan, Pentraxin and Presepsin in the first 3 days of ICU stay in a statistically significant manner, even if Presepsin decreased of 25% from day 1 to day 2 in the Pentaglobin group. It seems possible that Pentaglobin infusion reduces the Presepsin level in a more effective way if it were administered to a younger population (p = 0.012). In conclusion, age modifies the response of Presepsin to Pentaglobin and is a critical variable when investigating the effect of intravenous IgM-enriched immunoglobulins on sepsis.

The novel early predictive marker presepsin for postoperative pancreatic fistula: A pilot study.

Postoperative pancreatic fistula (PF) is a major and serious complication that occurs after pancreaticoduodenectomy (PD). The aim of the current study was to evaluate the use of a novel biomarker, presepsin, for predicting clinically relevant postoperative pancreatic fistula (CR-POPF) after PD. A prospective pilot study was conducted using 30 consecutive patients who underwent PD. Risk factors and candidates for predictive biomarkers for CR-POPF were statistically analyzed. CR-POPF (grade B and C; determined according to the guidelines of the International Study Group of Pancreatic Fistula) occurred in 15 patients (50%). Univariate analysis revealed that certain underlying conditions, including non-pancreatic cancer, smaller pancreatic ducts and soft pancreas texture were significantly associated with CR-POPF (P=0.005, P=0.004 and P=0.014, respectively). Furthermore, on day 1 post surgery (POD1), white blood cell count (P=0.040), levels of serum amylase (P=0.002) and serum presepsin (P=0.012), and the concentration of presepsin in drainage fluid (P<0.001) were significantly increased in CR-POPF compared with non-CR-POPF cases. Receiver operating characteristic curve analyses revealed that, on POD1, serum amylase and the concentration of presepsin in drainage fluid had an area under the curve value exceeding 0.8. A multivariate logistic regression analysis revealed that a higher concentration of presepsin in the drainage fluid was an independent predictive marker for CR-POPF (odds ratio, 14.503; 95% confidence interval, 1.750-120.229; P=0.013). To the best of our knowledge, the present study demonstrated for the first time that presepsin concentration in drainage fluid is a useful marker of CR-POPF after PD.

Serum level of soluble CD14 subtype predicts long-term prognosis in sepsis patients with cardiac dysfunction.

BACKGROUND: Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection, and some sepsis patients will develop cardiac dysfunction. Sepsis-induced cardiac dysfunction (SICD) has been demonstrated to be a promising predictor of mortality, although the prediction of SICD itself remains unclear. Clinical studies have shown that soluble CD14 subtype (sCD14-ST) may be a useful predictor for sepsis. In this study, we aimed to evaluate the predictive value of sCD14-ST for SICD in patients with sepsis. METHODS: Patients with SICD from three intensive care units (ICUs) of three medical centers between January 2015 and December 2018 were enrolled. Clinical data and information were collected from hospital and clinic records. Blood samples at admission were collected and serum levels of sCD14-ST were tested. Patients were followed up for at least 1 year. Major adverse cardiovascular events (MACEs) were recorded. Echocardiography was repeated at the end of 1-year follow-up. RESULTS: A total of 117 patients were enrolled into the final analysis. During 1-year follow-up, MACEs occurred in 35 (29.9%) patients. Most MACEs occurred with 3 months after discharge. Univariate and multivariate analysis revealed that age (OR =1.5, 95% CI: 1.2-2.3, P=0.036), cardiac troponin T (cTnT) (OR =1.4, 95% CI: 1.2-2.1, P=0.027), creatine (Cr) (OR =1.6, 95% CI: 1.3-2.5, P=0.022), sequential organ failure assessment (SOFA) score (OR =1.7, 95% CI: 1.3-2.6, P=0.012), and soluble cluster of differentiation 14 subtype (sCD14-ST) (OR =1.9, 95% CI:1.4-3.1, P=0.015) were predictors for MACEs in patients with SICD at 1-year follow-up. Area under receiver operating curve (AUROC) of sCD14-ST to MACEs was 0.784, and the cutoff point was 748.3 µg/L with a sensitivity of 0.78 and a specificity of 0.74 respectively. Blood test at the end of 1-year follow-up revealed that patients with a lower sCD14-ST level had better lower Cr, N-terminal pro-brain natriuretic peptide (NT-proBNP) and higher systolic blood pressure (SBP) and left ventricular ejection fraction (LVEF). CONCLUSIONS: MACEs mainly occurred within 3 months after discharge in patients with SICD, and high baseline serum levels of sCD14-ST predicted poor prognosis in patients with SICD.

Soluble CD14 Subtype in Peripheral Blood is a Biomarker for Early Diagnosis of Sepsis.

OBJECTIVE: To study the value of serum soluble CD14 subtype (sCD14-ST) in early diagnosis of sepsis. METHODS: Seventy-two patients were diagnosed with systemic inflammatory response syndrome, sepsis, or septic shock. Peripheral blood was collected at 0, 12, 24, and 48 hours after admission to the hospital. Levels of sCD14-ST, procalcitonin (PCT), hypersensitive C-reactive protein (CRP), and white blood cells (WBC) were determined. RESULTS: Levels of sCD14-ST in the patients with septic shock were higher than those in the other patients (P < .01) and peaked at 48 h. PCT and CRP levels were similar in the patients at admission but increased by 5 times to 10 times in the next 48 h, especially in the patients with septic shock. WBC levels remained high and did not change dramatically. Receiver operating characteristic analysis revealed that the area under the curve, sensitivity, and specificity values of sCD14-ST to diagnose sepsis were much higher than those of the other markers. CONCLUSION: Compared with PCT, CRP, and WBC, sCD14-ST is a better biomarker for the early diagnosis of sepsis.

Correlation between neutrophil gelatinase-associated lipocalin and soluble CD14 subtype on the prognosis evaluation of acute paraquat poisoning patients.

OBJECTIVE: The objective of this article is to study the correlation between neutrophil gelatinase-associated lipocalin (NGAL) and soluble CD14 subtype (presepsin) on the severity and prognosis evaluation of acute paraquat poisoning (APP) patients. MATERIALS AND METHODS: We studied 120 APP patients who were divided into three groups: light (28 cases), moderate (52 cases), and heavy poisoning (40 cases) groups. Twenty healthy volunteers were enrolled as controls. RESULTS: Acute kidney injury (AKI) occurred in 86 APP patients (71.7%, 86 of 120). In AKI group, urine NGAL was elevated 3 h after treatment, serum NGAL was elevated 24 h after treatment, and serum creatine (SCr) was elevated 2 days after treatment, which were all significantly higher than non-AKI group. Compared with control group, there were significant differences in presepsin and acute physiology and chronic health status (APACHE) II score of different poisoning groups. There were significant differences in detection indices 24 h, 3 days, and 7 days after treatment among different poisoning groups. There was a positive correlation between urine NGAL and serum paraquat concentration, urine NGAL, and AKI morbidity (r 1 = 0.974, r 2 = 0.766, p < 0.001), suggesting higher urine NGAL level indicated higher AKI morbidity. Receiver operating characteristic curves analysis suggested serum presepsin level and urine NGAL level had higher sensitivity and specificity than APACHE II score when predicting 28-day mortality of APP patients. CONCLUSION: Serum and urine NGAL level is elevated earlier than SCr, which is important for the early diagnosis of APP. Serum presepsin and urine NGAL levels can be used as markers to diagnose the severity of AKI and predict the mortality of APP patients.

A Prospective Study of Presepsin as an Indicator of the Severity of Community-Acquired Pneumonia in Emergency Departments: Comparison with Pneumonia Severity Index and CURB-65 Scores.

Despite widely used severity indices such as the pneumonia severity index (PSI) and CURB-65, a rapid, easy-to-detect biological marker is required for assessment of community-acquired pneumonia (CAP) severity. We aimed to investigate the ability of presepsin to differentiate between high- and low-risk patients, categorized according to PSI and CURB-65 scores. This prospective study was performed in an emergency department (ED) with 90 CAP patients. Whole blood presepsin levels were measured with a point-of-care test instrument. Using PSI and CURB-65 scores, we classified patients into outpatient (low-score group of PSI and CURB-65) and inpatient (high-score group of PSI and CURB-65) management groups. Presepsin levels were significantly higher in CAP patients with the high-score groups compared to the corresponding low-score groups. Presepsin correlated well with low- and high-score PSI (ROC AUC: presepsin, 0.726; PCT, 0.614; CRP, 0.544) and CURB-65 groups (ROC AUC: presepsin, 0.669; PCT, 0.645; CRP, 0.602). Presepsin is a valuable biomarker for assessing and classifying CAP severity.

Sepsis Markers Soluble IL-2 Receptor and Soluble CD14 Subtype as Potential Biomarkers for Complete Mucosal Healing in Patients With Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Novel noninvasive biomarkers with high diagnostic accuracy are required to assess mucosal healing, which is associated with sustained clinical remission, in inflammatory bowel disease. This study aimed to explore sepsis markers as potential biomarkers for mucosal healing. METHODS: Patients with ulcerative colitis [UC] or Crohn's disease [CD], who underwent blood tests for C-reactive protein [CRP], serum procalcitonin [PCT], soluble interleukin-2 receptor [sIL-2R], and plasma soluble CD14 subtype [sCD14-ST] within 2 weeks of endoscopy, were retrospectively recruited; and we assessed the relationship between marker levels and clinical features. Complete mucosal healing [cMH] was defined as a Mayo endoscopic subscore [MES] of 0 for UC and a simple endoscopic score for Crohn's disease [SES-CD] of 0 for CD. RESULTS: In all, 68 UC patients and 33 CD patients were included in this study. In patients with UC, the sIL-2R level was significantly higher in patients without cMH than in those with cMH. The sIL-2R level had the highest diagnostic value for identifying cMH in UC. In patients with CD, CRP and sCD14-ST levels were significantly higher in patients without cMH than in those with cMH, and both CRP and sCD14-ST had good diagnostic values for identifying cMH. The sCD14-ST level had a high diagnostic value for identifying cMH even among CD patients with complete clinical remission, defined as a Harvey-Bradshaw index of 0. CONCLUSIONS: The sIL-2R and sCD14-ST levels in patients with UC and CD, respectively, can be useful surrogate markers for identifying mucosal healing in inflammatory bowel disease.

Presepsin and procalcitonin as biomarkers of systemic bacterial infection in patients with rheumatoid arthritis.

AIM: To assess the diagnostic values of presepsin and procalcitonin in patients with rheumatoid arthritis (RA) by identifying those with bacterial infection METHOD: During June 2014-September 2015, 126 patients with RA and 25 healthy controls were enrolled. RA patients were divided into an infection group and a non-infection group. Infection was diagnosed by clinical symptoms, microbiological or radiographic methods, and good response to antibiotics. Concentrations of plasma presepsin, serum procalcitonin, C-reactive protein (CRP), and white blood cell counts (WBC) were measured and compared in each group. The correlations with the Sequential Organ Failure Assessment (SOFA) Score and these markers were calculated. RESULTS: RA patients included 26 patients in the infection group, 45 patients in the CRP-positive non-infection group (CRP > 0.3 mg/dL), and 55 patients in the CRP-negative non-infection group (CRP < 0.3 mg/dL). Levels of presepsin and procalcitonin in the infection group were highest and significantly higher than those in the CRP-positive non-infection group (presepsin 682.8 ± 158.1 pg/mL vs. 192.0 ± 12.0 pg/mL [P < 0.0001]; procalcitonin 4.052 ± 1.637 ng/mL vs. 0.120 ± 0.032 ng/mL [(P < 0.0001]). According to receiver operating characteristic curve (ROC) analysis, presepsin and procalcitonin levels appeared to have a higher diagnostic accuracy for infection than CRP or WBC. For the infection group, the SOFA Score positively correlated with the concentration of presepsin but not with that of procalcitonin. CONCLUSION: Presepsin and procalcitonin may be useful to identify infection in RA patients. Presepsin may better reflect infection severity than procalcitonin.

Effect of soluble CD14 subtype on the prognosis evaluation of acute paraquat poisoning patients.

OBJECTIVE: To study the relationship between soluble CD14 subtype (also named presepsin) and the prognosis of acute paraquat poisoning (APP) patients. METHODS: We studied 85 APP patients who were divided into three groups: light (21 cases), moderate (37 cases) and heavy poisoning (27 cases) groups. Fifty healthy subjects were as control group. According to the conditions of prognosis, they were divided into two groups: survive group (28 cases) and death group (57 cases). We measured the concentration of presepsin in serum and the levels of CRP, TNF-α, IL-6 and IL-10 in venous blood. APACHE II scores were observed before treatment, 72 h and 7 d after treatment. RESULTS: The levels of presepsin, CRP, TNF-α, IL-6 and the scores of APACHE II in patients of three poisoning groups were increased at three different time points compared with control group, while the level of IL-10 was decreased. And there were significant differences between each poisoning groups (P<0.05). The levels of prespsin, CRP, TNF-α, IL-6 and the scores of APACHE II in patients of death group were higher than survive group at three different time points, while the level of IL-10 was lower (P<0.05). The mortality rates of three poisoning groups were 28.57%, 70.27% and 92.59%, and there were significant differences between each poisoning groups (P<0.05). The area under curve (AUC) of presepsin level and APACHE II scores of APP patients on admission were 0.862 and 0.731, respectively. Presepsin had a better predictive ability than APACHE II score for 28-day mortality rate in APP patients (P<0.05). The level of presepsin was negatively correlated with survival rates (r=0.291, P=0.007). CONCLUSION: Monitoring the level of presepsin in serum has an important role in assessing the severity of APP patients, guiding treatment and predicting prognosis.

Soluble CD14 subtype (sCD14-ST) is a biomarker for neonatal sepsis.

This prospective observational study evaluated soluble CD14 subtype (sCD14-ST) as an early diagnosis and monitoring biomarker for neonatal sepsis in controls, patients with sepsis, or systemic inflammatory response syndrome (SIRS). sCD14-ST, procalcitonin (PCT), C-reactive protein (CRP), white blood cell (WBC), and acute physiology and chronic health evaluation II (APACHE-II) score were evaluated before and after therapy. sCD14-ST levels were significantly higher in sepsis than in SIRS, and higher in SIRS than controls. Treatment significantly decreased sCD14-ST, APACHE-II, PCT, CRP, and WBC. sCD14-ST levels correlated with APACHE-II before and after therapy, and with PCT before therapy (r=0.201, P=0.05). The receiver operating characteristic area under the curve of sCD14-ST was 0.958. A 304.5 pg/mL cutoff value was associated with 95.8% sensitivity and 84.9% specificity. sCD14-ST had superior diagnostic power for neonatal sepsis than the other indicators. In conclusion, sCD14-ST is a potential biomarker for the early diagnosis and monitoring of neonatal sepsis.

Soluble CD14 subtype (sCD14-ST) presepsin in premature and full term critically ill newborns with sepsis and SIRS.

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.