ArticleCritical care explorations2024
Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use.
Article in Critical care explorations, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- The Sepsis ImmunoScore Predicts Sepsis, Mortality, and Deterioration Better than Clinical Scores and Widely Available Biomarkers.Diagnostics (Basel, Switzerland) · 2026Article
- Challenges in early detection and prognostication of sepsis: new approaches from the emergency department and intensive care unit.EClinicalMedicine · 2026Review
- Label-Free Leukocyte Biophysical Profiling Using Impedance-Deformability Cytometry for Rapid Cardiovascular Risk Stratification.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Recent advances in early screening and diagnosis of sepsis: a narrative review.Frontiers in cellular and infection microbiology · 2026Review
- Hyper-inflammation and immunosuppression: redefining sepsis therapy using modern approaches.Frontiers in pharmacology · 2026Review
- Temporal trends of a cellular host response test for sepsis and a comparison with selected biomarkers of inflammation and infection.Scientific reports · 2025Article
- Real-time viscoelastic deformability cytometry: High-throughput mechanical phenotyping of liquid and solid biopsies.Science advances · 2024Article
- Clinical Utility of Recently Food and Drug Administration-Approved IntelliSep Test (Sepsis Biomarker) for Early Diagnosis of Sepsis: Comparison with Other Biomarkers.Journal of clinical medicine · 2024Article
Corrections and comments
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Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess the in vitro IntelliSep test, a microfluidic assay that quantifies the state of immune activation by evaluating the biophysical properties of leukocytes, as a rapid diagnostic for sepsis.
designProspective cohort study.
settingFive emergency departments (EDs) in Louisiana, Missouri, North Carolina, and Washington. PATIENTS: Adult patients presenting to the ED with signs (two of four Systemic Inflammatory Response Syndrome criteria, where one must be temperature or WBC count) or suspicion (provider-ordered culture) of infection.
interventionsAll patients underwent testing with the IntelliSep using ethylene diamine tetraacetic acid-anticoagulated whole blood followed by retrospective adjudication for sepsis by sepsis-3 criteria by a blinded panel of physicians. MEASUREMENTS AND MAIN
resultsOf 599 patients enrolled, 572 patients were included in the final analysis. The result of the IntelliSep test is reported as the IntelliSep Index (ISI), ranging from 0.1 to 10.0, divided into three interpretation bands for the risk of sepsis: band 1 (low) to band 3 (high). The median turnaround time for ISI results was 7.2 minutes. The ISI resulted band 1 in 252 (44.1%), band 2 in 160 (28.0%), and band 3 in 160 (28.0%). Sepsis occurred in 26.6% (152 of 572 patients). Sepsis prevalence was 11.1% (95% CI, 7.5-15.7%) in band 1, 28.1% (95% CI, 21.3-35.8%) in band 2, and 49.4% (95% CI, 41.4-57.4%) in band 3. The Positive Percent Agreement of band 1 was 81.6% and the Negative Percent Agreement of band 3 was 80.7%, with an area under the receiver operating characteristic curve of 0.74. Compared with band 1, band 3 correlated with adverse clinical outcomes, including mortality, and resource utilization.
conclusionsIncreasing ISI interpretation band is associated with increasing probability of sepsis in patients presenting to the ED with suspected infection.
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