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Purpose <p>The assessment of genetic activation has shown good diagnostic capacity in identifying sepsis in patients at the emergency department or upon admission to the intensive care unit. This study evaluates a gene expression diagnostic test for identifying nosocomial infections in critically ill patients and compares it with well-established tests used in routine clinical practice.</p> Methods <p>This was a prospective, observational, non-interventional study conducted in a single intensive care unit of a tertiary university hospital. Adult critically ill patients were enrolled if their attending physician suspected a nosocomial ICU-acquired infection, and a comprehensive microbiological study was performed. The genetic host response was assessed using the SeptiCyte RAPID assay at study inclusion, alongside microbiological, analytical, and radiological evaluations.</p> Results <p>Sixty-nine patients were enrolled, of whom 78.3% (n 54) received empirical antimicrobial treatment. ICU-acquired infection was confirmed in 35 patients (50.7%). A bacterial etiology was established in 32 cases (91.4%), and viral reactivation was diagnosed in 2 cases (5.7%). Diagnostic capacity was measured as follows: procalcitonin AUC 0.600 (95% CI 0.454–0.745), C-reactive protein AUC 0.703 (95% CI 0.564–0.839) and Septi-Cyte RAPID AUC 0.995 (95% CI 0.930–1.003). The optimal cut-off point for Septi-cyte score was 6.35, yielding a sensitivity of 91.4%, specificity of 73.5%, and positive and negative predictive values of 78% and 89.3%, respectively.</p> Conclusions <p>Genetic activation analysis in patients with suspected ICU-acquired nosocomial sepsis demonstrated good diagnostic capability, even surpassing traditional inflammatory biomarkers.</p>

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Blood transcriptomic for the diagnosis of nosocomial infections in critically ill patients: an observational proof-of-concept study

  • 期刊论文

  • 发表日期：

    2025年8月11日

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  • Ruben Martín-Latorre,
  • Kaya Haener,
  • Hugo Arrando,
  • Juan Frasquet,
  • Mónica Gordón,
  • Amparo Martinez,
  • Carlos Folgado,
  • Álvaro Castellanos-Ortega,
  • Paula Ramirez

摘要

Purpose

The assessment of genetic activation has shown good diagnostic capacity in identifying sepsis in patients at the emergency department or upon admission to the intensive care unit. This study evaluates a gene expression diagnostic test for identifying nosocomial infections in critically ill patients and compares it with well-established tests used in routine clinical practice.

Methods

This was a prospective, observational, non-interventional study conducted in a single intensive care unit of a tertiary university hospital. Adult critically ill patients were enrolled if their attending physician suspected a nosocomial ICU-acquired infection, and a comprehensive microbiological study was performed. The genetic host response was assessed using the SeptiCyte RAPID assay at study inclusion, alongside microbiological, analytical, and radiological evaluations.

Results

Sixty-nine patients were enrolled, of whom 78.3% (n 54) received empirical antimicrobial treatment. ICU-acquired infection was confirmed in 35 patients (50.7%). A bacterial etiology was established in 32 cases (91.4%), and viral reactivation was diagnosed in 2 cases (5.7%). Diagnostic capacity was measured as follows: procalcitonin AUC 0.600 (95% CI 0.454–0.745), C-reactive protein AUC 0.703 (95% CI 0.564–0.839) and Septi-Cyte RAPID AUC 0.995 (95% CI 0.930–1.003). The optimal cut-off point for Septi-cyte score was 6.35, yielding a sensitivity of 91.4%, specificity of 73.5%, and positive and negative predictive values of 78% and 89.3%, respectively.

Conclusions

Genetic activation analysis in patients with suspected ICU-acquired nosocomial sepsis demonstrated good diagnostic capability, even surpassing traditional inflammatory biomarkers.