A Fully Integrated Diagnostic Test to Discriminate Sepsis from Infection-Negative Systemic Inflammation

Sepsis is a serious medical condition that manifests with a dysregulated immune response to an infection in the bloodstream, and is a major cause of morbidity and mortality worldwide. Many non-infectious conditions can lead to a state of hyper-inflammation known as the systemic inflammatory response syndrome (SIRS), which clinically can look very similar to sepsis.…

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Blood transcriptomic discrimination of bacterial and viral infections in the emergency department: a multi-cohort observational validation study

Abstract Background There is an urgent need to develop biomarkers that stratify risk of bacterial infection in order to support antimicrobial stewardship in emergency hospital admissions. Methods We used computational machine learning to derive a rule-out blood transcriptomic signature of bacterial infection (SeptiCyte™ TRIAGE) from eight published case-control studies. We then validated this signature by…

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Modeling Improved Patient Management and Hospital Savings with SeptiCyte™ LAB in the Diagnosis of Sepsis at ICU Admission

Background: The ability to accurately diagnose sepsis at ICU admission is key to effective clinical management, patient safety, and efficient hospital resource utilization. Most tests used for sepsis diagnosis, including pathogen detection and host-based biomarker approaches, are lacking in either sensitivity or specificity, resulting in a clinical assumption of sepsis, patient overtreatment with antimicrobials, and…

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A pilot study of a novel molecular host response assay to diagnose infection in patients after high-risk gastro-intestinal surgery

SeptiCyte LAB measures the expression of four host-response RNAs in peripheral blood to distinguish sepsis from sterile inflammation. This study evaluates whether sequential monitoring of this assay has diagnostic utility in patients after esophageal surgery. Among 370 esophagectomy patients, 120 (32%) subjects developed a complication requiring ICU (re)admission, 63 (53%) of whom could be analyzed.…

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Profile of the SeptiCyte™ LAB gene expression assay to diagnose infection in critically ill patients.

Sepsis is a severe and frequently occurring clinical syndrome, caused by the inflammatory response to infections. Recent studies on the human transcriptome during sepsis have yielded several gene-expression assays that might assist physicians during clinical assessment of patients suspected of sepsis. SeptiCyte™ LAB (Immunexpress, Seattle, WA) is the first gene expression assay that was cleared…

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