article · The Egyptian Journal of Internal Medicine
Sepsis presents a major clinical challenge due to vague early symptoms and the lack of a definitive single biomarker. An observational study assessed the diagnostic and prognostic role of serum presepsin in seventy-six confirmed sepsis patients compared with thirty healthy controls over a twenty-eight-day follow-up. Baseline presepsin levels were significantly elevated in sepsis patients compared to controls, successfully distinguishing between the two groups with complete accuracy at a threshold exceeding ninety nanograms per litre. However, admission presepsin levels did not differentiate between patients with positive or negative blood cultures. While Day 3 presepsin levels, lactate, and organ dysfunction scores correlated with twenty-eight-day mortality in univariate testing, only the Sequential Organ Failure Assessment score served as an independent predictor in multivariate analysis. Presepsin shows utility as an adjunctive diagnostic tool rather than a standalone prognostic metric.
Early recognition of sepsis is critical to reducing illness and death, but current clinical criteria often lack diagnostic specificity. Demonstrating that presepsin accurately separates sepsis patients from healthy individuals supports its potential use alongside existing clinical scoring systems. This aids healthcare professionals in identifying systemic infections more promptly and monitoring disease trajectory over the initial days of hospitalisation.
The findings support the development of presepsin assays as diagnostic screening aids for clinical laboratories and hospital emergency departments. Because the biomarker successfully separates healthy controls from sepsis patients, diagnostic manufacturers could incorporate presepsin into acute-care panels. However, as an applied clinical study with limited sample size and no independent prognostic predictive capability, the biomarker remains in translational clinical evaluation rather than near-market diagnostic deployment.
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Abstract Background Sepsis is a major global healthcare challenge with high morbidity, mortality, and economic burden. Early recognition is difficult because initial symptoms may be vague, and no single biomarker provides a definitive diagnosis. While current guidelines emphasize organ dysfunction scores, Systemic Inflammatory Response Syndrome (SIRS) criteria remain utilized globally as a sensitive screening tool despite its limited specificity. Therefore, this study evaluates the diagnostic and prognostic value of presepsin in confirmed sepsis patients as an accessible and cost-effective biomarker. Methods The study initially included 100 patients meeting SIRS criteria and 30 healthy controls. Twenty-four patients were excluded from the analysis: four due to a lack of confirmed infection based on clinical, laboratory, microbiological, and radiological findings, and twenty due to missing Day 3 blood samples during routine care. The remaining 76 patients were followed for 28-day outcomes, with 57 survivors and 19 deaths. Cultures were performed at admission, while serum presepsin and other biomarkers were assessed at baseline and on Day 3. Sequential Organ Failure Assessment (SOFA) and quick (SOFA) scores were calculated on admission. Results In this study, baseline presepsin was higher in patients than controls (500 vs. 65 ng/L, P < 0.0001). Presepsin differentiated sepsis from controls with an area under the curve (AUC) = 1.000. A cutoff > 90 ng/L achieved 100% sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Univariate analysis linked SOFA (OR = 2.009, P = 0.000) and Day 3 presepsin (OR = 1.002, P = 0.024) to 28-day mortality, unlike creatinine and lactate. In multivariate analysis, only SOFA independently predicted mortality (OR = 2.049, P = 0.001). Conclusions Presepsin showed potential value as an adjunctive biomarker for sepsis assessment and prognostic evaluation. At a cutoff > 90 ng/L, Presepsin demonstrates perfect performance distinguishing sepsis patients from controls. Admission presepsin did not differentiate between culture-positive and culture-negative patients. Higher Day 3 presepsin, lactate, and SOFA scores were associated with 28-day mortality. In multivariate analysis, higher SOFA scores independently predicted 28-day mortality.
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DOI: 10.1186/s43162-026-00715-x
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