Startseite The accuracy of presepsin in diagnosing neonatal late-onset sepsis in critically ill neonates: a prospective study
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The accuracy of presepsin in diagnosing neonatal late-onset sepsis in critically ill neonates: a prospective study

  • Cinzia Auriti ORCID logo EMAIL logo , Domenico Umberto De Rose , Chiara Maddaloni , Lucilla Ravà , Ludovica Martini , Eleonora Di Tommaso , Paola Bernaschi , Emanuel Paionni , Ottavia Porzio , Fiammetta Piersigilli , Marco Iannetta , Andrea Dotta und Maria Paola Ronchetti
Veröffentlicht/Copyright: 21. April 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 63 Heft 9

Abstract

Objectives

The diagnostic accuracy of presepsin (P-SEP) in the newborn is still under evaluation.

Methods

In a multicenter study, we studied the accuracy of P-SEP as a diagnostic marker of late-onset sepsis (LOS) in critical newborns with underlying disorders, to define the most accurate cut-off to distinguish infected from uninfected patients.

Results

Sixty-nine/351 newborns without infections at admission developed LOS. The median P-SEP value at T0 (admission) was 518.0 ng/L (IQR 313.0–789.0), without significant differences related to underlying diseases (p=0.52). In neonates who developed LOS, P-SEP increased at the onset of infection (T1) (median: 816.0 ng/L) and after 24–48 h (median: 901.0 ng/L) compared with their value at admission (median: 560.0 ng/L) (p<0.01 and p=0.03, respectively). The area under the ROC curve at T1 was 0.71 (95 % CI 0.65–0.78) when all cases of sepsis were included in the analysis and increased to 0.74 (95 % CI 0.66–0.81) considering only confirmed sepsis. Approximately two-thirds of patients were correctly classified, setting the cut-off at 713 ng/L, with a negative predictive value of 89.0 %.

Conclusions

At a cut-off of 713 ng/L, P-SEP has good accuracy in diagnosing LOS in critically ill newborns. In uninfected newborns, the median value of P-SEP is not influenced by any underlying pathology.

Keywords: newborn; neonatal sepsis; presepsin; biomarkers; sCD14-ST
Corresponding author: Cinzia Auriti, Saint Camillus International University of Health and Medical Sciences, Rome, Italy; and Casa di Cura Villa Margherita, Rome, Italy, Email:
Cinzia Auriti and Domenico Umberto De Rose contributed equally to this work.

Funding source: Ministero della Salute

Award Identifier / Grant number: Current Research Funds

Funding source: Gepa S.r.l. Italy

Award Identifier / Grant number: 202103_GEPA_AURITI

Acknowledgments

We would like to thank Mitsubishi Chemical Europe and Gepa S.r.l., Italy, for technical support and for the use of the immunoassay analyzer. We also would like to thank Dr. Vincenzo Di Ciommo for his supervision in statistical analysis of data.

  1. Research ethics: All procedures performed in this study were in accordance with the ethical standards of the Institutional and National Research Committee and with the Declaration of Helsinki (as revised in 2013). The study was approved by the Institutional Review Board (protocol number: PRENEOSEP v 2.1 – n. 624–29/04/2021). Personal data were restricted to essential information and were treated to guarantee the respect of the involved patients’ privacy, as stated by Italian Law D. Lgs. N. 196 of 2003 about personal data protection.

  2. Informed consent: Written informed consent was obtained from all individuals included in this study, or their legal guardians or wards.

  3. Author contributions: Cinzia Auriti: Conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; project administration; supervision; writing – original draft; writing – review and editing. Domenico Umberto De Rose: Conceptualization; data curation; formal analysis; investigation; methodology; project administration; writing – original draft; writing – review and editing. Chiara Maddaloni: Conceptualization; data curation; formal analysis; investigation; methodology; writing – original draft; writing – review and editing. Lucilla Ravà: Data curation; formal analysis; investigation; methodology; writing – review and editing. Ludovica Martini: Data curation; writing – review and editing. Eleonora Di Tommaso: Data curation; writing – review and editing. Paola Bernaschi: Data curation; formal analysis; writing – review and editing. Emanuel Paionni: Data curation; formal analysis; writing – review and editing. Ottavia Porzio: Data curation; formal analysis; writing – review and editing. Fiammetta Piersigilli: Data curation; formal analysis; writing – review and editing. Marco Iannetta: writing – review and editing. Andrea Dotta: Supervision; writing – review and editing. Maria Paola Ronchetti: Conceptualization; investigation; project administration; writing – review and editing. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors have no conflicts of interest to disclose. Gepa S.r.l. Italy provided the kits to measure presepsin and remained blinded from the results of the study.

  6. Research funding: The study was supported by the fund “202103_GEPA_AURITI” from Gepa S.r.l. Italy and by the Current Research funds from the Italian Ministry of Health.

  7. Data availability: All data relevant to the study are included in the article or uploaded supplementary information. Other details are available upon reasonable request.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2025-0128).

Received: 2025-02-03
Accepted: 2025-04-10
Published Online: 2025-04-21
Published in Print: 2025-08-26

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0128
Schlagwörter für diesen Artikel
newborn; neonatal sepsis; presepsin; biomarkers; sCD14-ST

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Macroprolactinaemia – some progress but still an ongoing problem
  4. Review
  5. Understanding the circulating forms of cardiac troponin: insights for clinical practice
  6. Opinion Papers
  7. New insights in preanalytical quality
  8. IFCC recommendations for internal quality control practice: a missed opportunity
  9. Genetics and Molecular Diagnostics
  10. Evaluation of error detection and treatment recommendations in nucleic acid test reports using ChatGPT models
  11. General Clinical Chemistry and Laboratory Medicine
  12. Pre-analytical phase errors constitute the vast majority of errors in clinical laboratory testing
  13. Improving the efficiency of quality control in clinical laboratory with an integrated PBRTQC system based on patient risk
  14. IgA-type macroprolactin among 130 patients with macroprolactinemia
  15. Prevalence and re-evaluation of macroprolactinemia in hyperprolactinemic patients: a retrospective study in the Turkish population
  16. Defining dried blood spot diameter: implications for measurement and specimen rejection rates
  17. Screening primary aldosteronism by plasma aldosterone-to-angiotensin II ratio
  18. Assessment of serum free light chain measurements in a large Chinese chronic kidney disease cohort: a multicenter real-world study
  19. Beyond the Hydrashift assay: the utility of isoelectric focusing for therapeutic antibody and paraprotein detection
  20. Direct screening and quantification of monoclonal immunoglobulins in serum using MALDI-TOF mass spectrometry without antibody enrichment
  21. Effect of long-term frozen storage on stability of kappa free light chain index
  22. Impact of renal function impairment on kappa free light chain index
  23. Standardization challenges in antipsychotic drug monitoring: insights from a national survey in Chinese TDM practices
  24. Potential coeliac disease in children: a single-center experience
  25. Vitamin D metabolome in preterm infants: insights into postnatal metabolism
  26. Candidate Reference Measurement Procedures and Materials
  27. Development of commutable candidate certified reference materials from protein solutions: concept and application to human insulin
  28. Reference Values and Biological Variations
  29. Biological variation of serum cholinesterase activity in healthy subjects
  30. Hematology and Coagulation
  31. Diagnostic performance of morphological analysis and red blood cell parameter-based algorithms in the routine laboratory screening of heterozygous haemoglobinopathies
  32. Cancer Diagnostics
  33. Promising protein biomarkers for early gastric cancer: clinical performance of combined detection
  34. Infectious Diseases
  35. The accuracy of presepsin in diagnosing neonatal late-onset sepsis in critically ill neonates: a prospective study
  36. Corrigendum
  37. The Unholy Grail of cancer screening: or is it just about the Benjamins?
  38. Letters to the Editor
  39. Analytical validation of hemolysis detection on GEM Premier 7000
  40. Reconciling reference ranges and clinical decision limits: the case of thyroid stimulating hormone
  41. Contradictory definitions give rise to demands for a right to unambiguous definitions
  42. Biomarkers to measure the need and the effectiveness of therapeutic supplementation: a critical issue
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