Abstract Introduction Sepsis is defined as life-threatening organ dysfunction due to a dysregulated host response to infection. Since it was first defined in 1992, it has continued to be redefined with no test or gold standard to identify patients with sepsis. Early recognition of sepsis remains challenging, as physiologic criteria (e.g., Systemic Inflammatory Response Syndrome SIRS) lack specificity. Despite these limitations, the SIRS criteria have been widely used for quality improvement (QI) projects to educate clinicians and the public about sepsis’ early symptoms and how delaying treatment can be fatal. Cytovale’s IntelliSep test assigns risk to Bands 1-3 based on leukocyte biophysical properties. This QI pilot assessed diagnostic performance and outcomes after incorporating band 3 into emergency department (ED) workflows. Methods A three-month pilot (June 17-September 16, 2025) was conducted at a single community ED. The test used is FDA-cleared for adults with suspected infection and excludes patients 18 years old, those with hematologic malignancy, myelodysplastic or myeloproliferative disorders, prior stem cell or solid-organ transplant, or recent cytotoxic chemotherapy (≤3 months). Encounters with suspected infection (triage or electronic health record EHR alert, or physician suspicion) were eligible. Performance metrics were compared with a one-month pre-implementation baseline (April 14-May 15). Primary endpoints included sepsis identification (ICD-10/DRG at discharge), antibiotic initiation, and safe disposition. Results Among 12,444 ED visits, 1,433 patients were tested. Sepsis prevalence among tested patients rose from 13.9% at baseline to 17.2% during the pilot. Diagnostic performance improved (area under the curve AUC 0.81 → 0.88; sensitivity 90.6 %, specificity 95.2 %, PPV 78.2 %, NPV 95.9 %). Within Band 3 patients (N = 234), 79% had confirmed sepsis, 98% received IV antibiotics (71% broad-spectrum), and 98% had blood cultures ordered. ED discharge declined from 17% to 1%, 3-day sepsis readmissions fell from 2.9% to 0%, and inpatient admissions increased from 69% to 90%. Notably, 43% of Band 3 sepsis patients did not meet SIRS criteria within the first hour, yet 99% received sepsis-directed management. Conclusions The use of the cellular host response test’s band 3 improved diagnostic accuracy and streamlined early sepsis management. Clinicians had high confidence in test-guided decisions, as evidenced by almost complete treatment of high-risk patients and the elimination of early sepsis readmissions. These findings support IntelliSep’s Band 3 utility as an adjunct for timely, targeted care in the emergency department. This abstract is funded by: None
Taha et al. (Fri,) studied this question.