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Objectives <p>The aim of this study was to validate the SeptiCyte® RAPID assay, a molecular test to distinguish sepsis from sterile inflammation, by determining its diagnostic accuracy in critically ill patients who meet criteria for sepsis according to Sepsis-3 definition on ICU admission&#xa0;</p> Design <p>This is an observational, prospective, and multicenter study.Setting: Carried out in seven hospitals in Andalusia (Spain). A 2.5 mL whole blood sample was collected and tested in a SeptiCyte RAPID kit on a real time PCR platform (IdyllaTM). A score from 0 to 15 (SeptiScore™) was generated that falls into four bands based on the increasing likelihood of infection-positive systemic inflammation.</p> Patients <p>Patients aged 18 years or older, admitted to the ICU with a diagnosis of sepsis.Main results: We enrolled 354 patients, of whom 86 (24.3%) did not present sepsis at the researchers´ discretion. SeptiCyte® RAPID showed an AUC of [0.84 (CI95% 0.79-0.87)] for differentiating sepsis from sterile systemic inflammation. SeptiCyte® RAPID was significantly better for sepsis diagnosis than CRP [0.75 (CI95% 0.70-0.80)] (p =0.003) but without significant differences with PCT [0.80 (CI95% 0.75-0.84)]. SeptiScore distribution in patients with sepsis was higher than patients with sterile inflammation, with a PPV of 68.8% and 92.2% (Bands 3 and 4) for sepsis diagnosis and a PPV of 100% for sterile inflammation (Band 1). Independent risk factors for sepsis were estimated probability of sepsis [OR 8.02 (CI 95% 4.50-14.28), p&lt;0.001], SeptiScore [OR 1.64 (CI 95% 1.35-1.99), p&lt;0.001], and log procalcitonin [OR 1.68 (CI 95% 1.09-2.59), p=0.020].Conclusions: SeptiCyte® RAPID discriminates sepsis from sterile inflammation in critically ill adults, adding value to the diagnosis of sepsis.</p> Purpose <p>The aim of this study was to validate the SeptiCyte® RAPID assay, a molecular test to distinguish sepsis from sterile inflammation, by determining its diagnostic accuracy in critically ill patients who meet criteria for sepsis according to Sepsis-3 definition on ICU admission.Methods: This is an observational, prospective, and multicenter study. Carried out in seven hospitals in Andalusia (Spain). A 2.5 mL whole blood sample was collected and tested in a SeptiCyte RAPID kit on a real time PCR platform (IdyllaTM). A score from 0 to 15 (SeptiScore™) was generated that falls into four bands based on the increasing likelihood of infection-positive systemic inflammation.Patients aged 18 years or older, admitted to the ICU with a diagnosis of sepsis were included.</p> Results <p>We enrolled 353 patients, of whom 86 (23.7%) did not present sepsis at the researchers´ discretion. SeptiCyte® RAPID showed an AUC of [0.84 (CI95% 0.79-0.87)] for differentiating sepsis from sterile systemic inflammation. SeptiCyte® RAPID was significantly better for sepsis diagnosis than CRP [0.75 (CI95% 0.70-0.80)] (p =0.003) but without significant differences with PCT [0.80 (CI95% 0.75-0.84)]. SeptiScore distribution in patients with sepsis was higher than patients with sterile inflammation, with a PPV of 68.8% and 92.2% (Bands 3 and 4) for sepsis diagnosis and a PPV of 100% for sterile inflammation (Band 1). Independent risk factors for sepsis were physicians´ subjective likelihood of sepsis [intermediate probabilty OR 4.55 (95% CI 1.61-12.83), p=0.004 and high probabilty OR 72.04 (95% CI 20.85-248.93), p&lt;0.001], SeptiScore [OR 1.65 (95% CI 1.32-2.07), p&lt;0.001], and log procalcitonin [OR 1.74 ( 95% CI 1.08-2.79), p=0.022].Conclusions: SeptiCyte® RAPID discriminates sepsis from sterile inflammation in critically ill adults, adding value to the diagnosis of sepsis.</p>

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Diagnostic accuracy of SeptiCyte® RAPID to discriminate sepsis from non-infectious critical illness in patients meeting sepsis criteria according to sepsis-3 definition at ICU admission

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月23日

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  • María Luisa Cantón-Bulnes,
  • José Luís García-Garmendia,
  • Ángel Estella,
  • Adela Fernández-Galilea,
  • Isidro Blanco,
  • María Antonia Estecha-Foncea,
  • Marina Gordillo-Resina,
  • Jorge Rodríguez-Gómez,
  • Juan Jesús Pineda-Capitán,
  • Carmen Martínez-Fernández,
  • Ana Escoresca-Ortega,
  • Rosario Amaya-Villar,
  • Juan Mora-Ordóñez,
  • Sara González-Soto,
  • José Garnacho-Montero

摘要

Objectives

The aim of this study was to validate the SeptiCyte® RAPID assay, a molecular test to distinguish sepsis from sterile inflammation, by determining its diagnostic accuracy in critically ill patients who meet criteria for sepsis according to Sepsis-3 definition on ICU admission 

Design

This is an observational, prospective, and multicenter study.Setting: Carried out in seven hospitals in Andalusia (Spain). A 2.5 mL whole blood sample was collected and tested in a SeptiCyte RAPID kit on a real time PCR platform (IdyllaTM). A score from 0 to 15 (SeptiScore™) was generated that falls into four bands based on the increasing likelihood of infection-positive systemic inflammation.

Patients

Patients aged 18 years or older, admitted to the ICU with a diagnosis of sepsis.Main results: We enrolled 354 patients, of whom 86 (24.3%) did not present sepsis at the researchers´ discretion. SeptiCyte® RAPID showed an AUC of [0.84 (CI95% 0.79-0.87)] for differentiating sepsis from sterile systemic inflammation. SeptiCyte® RAPID was significantly better for sepsis diagnosis than CRP [0.75 (CI95% 0.70-0.80)] (p =0.003) but without significant differences with PCT [0.80 (CI95% 0.75-0.84)]. SeptiScore distribution in patients with sepsis was higher than patients with sterile inflammation, with a PPV of 68.8% and 92.2% (Bands 3 and 4) for sepsis diagnosis and a PPV of 100% for sterile inflammation (Band 1). Independent risk factors for sepsis were estimated probability of sepsis [OR 8.02 (CI 95% 4.50-14.28), p<0.001], SeptiScore [OR 1.64 (CI 95% 1.35-1.99), p<0.001], and log procalcitonin [OR 1.68 (CI 95% 1.09-2.59), p=0.020].Conclusions: SeptiCyte® RAPID discriminates sepsis from sterile inflammation in critically ill adults, adding value to the diagnosis of sepsis.

Purpose

The aim of this study was to validate the SeptiCyte® RAPID assay, a molecular test to distinguish sepsis from sterile inflammation, by determining its diagnostic accuracy in critically ill patients who meet criteria for sepsis according to Sepsis-3 definition on ICU admission.Methods: This is an observational, prospective, and multicenter study. Carried out in seven hospitals in Andalusia (Spain). A 2.5 mL whole blood sample was collected and tested in a SeptiCyte RAPID kit on a real time PCR platform (IdyllaTM). A score from 0 to 15 (SeptiScore™) was generated that falls into four bands based on the increasing likelihood of infection-positive systemic inflammation.Patients aged 18 years or older, admitted to the ICU with a diagnosis of sepsis were included.

Results

We enrolled 353 patients, of whom 86 (23.7%) did not present sepsis at the researchers´ discretion. SeptiCyte® RAPID showed an AUC of [0.84 (CI95% 0.79-0.87)] for differentiating sepsis from sterile systemic inflammation. SeptiCyte® RAPID was significantly better for sepsis diagnosis than CRP [0.75 (CI95% 0.70-0.80)] (p =0.003) but without significant differences with PCT [0.80 (CI95% 0.75-0.84)]. SeptiScore distribution in patients with sepsis was higher than patients with sterile inflammation, with a PPV of 68.8% and 92.2% (Bands 3 and 4) for sepsis diagnosis and a PPV of 100% for sterile inflammation (Band 1). Independent risk factors for sepsis were physicians´ subjective likelihood of sepsis [intermediate probabilty OR 4.55 (95% CI 1.61-12.83), p=0.004 and high probabilty OR 72.04 (95% CI 20.85-248.93), p<0.001], SeptiScore [OR 1.65 (95% CI 1.32-2.07), p<0.001], and log procalcitonin [OR 1.74 ( 95% CI 1.08-2.79), p=0.022].Conclusions: SeptiCyte® RAPID discriminates sepsis from sterile inflammation in critically ill adults, adding value to the diagnosis of sepsis.