Evidence map›Paper›PMID 41729344›Full record

Observational studyEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2026

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.

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 and 5 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

María Luisa Cantón-BulnesHospital Universitario Virgen Macarena (Sevilla), Intensive Care Unit, Seville, Spain.
José Luís García-GarmendiaHospital San Juan de Dios del Aljarafe (Sevilla), Intensive Care Unit, Sevilla, Spain.
Ángel EstellaHospitalUniversitario de Jerez de la Frontera (Cádiz), Intensive Care Unit, Cadiz, Spain. angel.estella@uca.es.
Adela Fernández-GalileaHospital Universitario Virgen Macarena (Sevilla), Intensive Care Unit, Seville, Spain.
Isidro BlancoHospitalUniversitario de Jerez de la Frontera (Cádiz), Intensive Care Unit, Cadiz, Spain.
María Antonia Estecha-FonceaHospitalUniversitario Virgen de la Victoria (Málaga), Intensive Care Unit, Málaga, Spain.
Marina Gordillo-ResinaHospitalUniversitario Virgen de la Victoria (Málaga), Intensive Care Unit, Málaga, Spain.
Jorge Rodríguez-GómezHospitalUniversitario Reina Sofía (Córdoba), Intensive Care Unit, Córdoba, Spain.
Juan Jesús Pineda-CapitánHospitalUniversitario Reina Sofía (Córdoba), Intensive Care Unit, Córdoba, Spain.
Carmen Martínez-FernándezHospital San Juan de Dios del Aljarafe (Sevilla), Intensive Care Unit, Sevilla, Spain.
Ana Escoresca-OrtegaHospitalUniversitario Virgen del Rocío (Sevilla), Intensive Care Unit, Sevilla, Spain.
Rosario Amaya-VillarHospitalUniversitario Virgen del Rocío (Sevilla), Intensive Care Unit, Sevilla, Spain.
Juan Mora-OrdóñezHospitalUniversitario Regional de Málaga (Málaga), Intensive Care Unit, Málaga, Spain.
Sara González-SotoHospitalUniversitario Regional de Málaga (Málaga), Intensive Care Unit, Málaga, Spain.
José Garnacho-MonteroHospitalUniversitario Virgen del Rocío (Sevilla), Intensive Care Unit, Sevilla, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe 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 

designThis is an observational, prospective, and multicenter study.

settingCarried 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

resultsWe 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].

conclusionsSeptiCyte® 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.

methodsThis 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.

resultsWe 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].

conclusionsSeptiCyte® RAPID discriminates sepsis from sterile inflammation in critically ill adults, adding value to the diagnosis of sepsis.

Indexed as

Critical IllnessSepsisAdultAgedAged, 80 and overFemaleHumansIntensive Care UnitsMaleMiddle AgedProspective StudiesReal-Time Polymerase Chain ReactionSensitivity and SpecificitySpainBiomarkersDiagnosis accuracyICUMortalitySepsisSeptycite

Identifiers

PMID41729344
PMCPMC13319364

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.