Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use
OBJECTIVES:. To 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. DESIGN:. Prospective cohort study. SETTING:. Five emergency departments (EDs) in Louisian...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer
2024-02-01
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| Series: | Critical Care Explorations |
| Online Access: | http://journals.lww.com/10.1097/CCE.0000000000001026 |
| _version_ | 1797292755523731456 |
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| author | Hollis R. O’Neal, Jr, MD, MSc Roya Sheybani, PhD David R. Janz, MD, MSc Robert Scoggins, MD, PhD Tonya Jagneaux, MD James E. Walker, MD, PhD Daniel J. Henning, MD, MPH Elizabeth Rosenman, MD Simon A. Mahler, MD, MS Hariharan Regunath, MD Christopher S. Sampson, MD D. Clark Files, MD Richard D. Fremont, MD Michael J. Noto, MD, PhD Erica E. Schneider, MD Wesley R. Shealey, MD Matthew S. Berlinger, MD Thomas C. Carver, MD Morgan K. Walker, MD Nathan A. Ledeboer, PhD Ajay M. Shah, PhD Henry T.K. Tse, PhD Dino DiCarlo, PhD Todd W. Rice, MD, MSc Christopher B. Thomas, MD |
| author_facet | Hollis R. O’Neal, Jr, MD, MSc Roya Sheybani, PhD David R. Janz, MD, MSc Robert Scoggins, MD, PhD Tonya Jagneaux, MD James E. Walker, MD, PhD Daniel J. Henning, MD, MPH Elizabeth Rosenman, MD Simon A. Mahler, MD, MS Hariharan Regunath, MD Christopher S. Sampson, MD D. Clark Files, MD Richard D. Fremont, MD Michael J. Noto, MD, PhD Erica E. Schneider, MD Wesley R. Shealey, MD Matthew S. Berlinger, MD Thomas C. Carver, MD Morgan K. Walker, MD Nathan A. Ledeboer, PhD Ajay M. Shah, PhD Henry T.K. Tse, PhD Dino DiCarlo, PhD Todd W. Rice, MD, MSc Christopher B. Thomas, MD |
| author_sort | Hollis R. O’Neal, Jr, MD, MSc |
| collection | DOAJ |
| description | OBJECTIVES:. To 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.
DESIGN:. Prospective cohort study.
SETTING:. Five 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.
INTERVENTIONS:. All 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 RESULTS:. Of 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.
CONCLUSIONS:. Increasing ISI interpretation band is associated with increasing probability of sepsis in patients presenting to the ED with suspected infection. |
| first_indexed | 2024-03-07T20:02:07Z |
| format | Article |
| id | doaj.art-63538c9b3c63401cb6b64ae711591b01 |
| institution | Directory Open Access Journal |
| issn | 2639-8028 |
| language | English |
| last_indexed | 2024-03-07T20:02:07Z |
| publishDate | 2024-02-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | Critical Care Explorations |
| spelling | doaj.art-63538c9b3c63401cb6b64ae711591b012024-02-28T06:47:23ZengWolters KluwerCritical Care Explorations2639-80282024-02-0162e102610.1097/CCE.0000000000001026202402000-00007Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department UseHollis R. O’Neal, Jr, MD, MSc0Roya Sheybani, PhD1David R. Janz, MD, MSc2Robert Scoggins, MD, PhD3Tonya Jagneaux, MD4James E. Walker, MD, PhD5Daniel J. Henning, MD, MPH6Elizabeth Rosenman, MD7Simon A. Mahler, MD, MS8Hariharan Regunath, MD9Christopher S. Sampson, MD10D. Clark Files, MD11Richard D. Fremont, MD12Michael J. Noto, MD, PhD13Erica E. Schneider, MD14Wesley R. Shealey, MD15Matthew S. Berlinger, MD16Thomas C. Carver, MD17Morgan K. Walker, MD18Nathan A. Ledeboer, PhD19Ajay M. Shah, PhD20Henry T.K. Tse, PhD21Dino DiCarlo, PhD22Todd W. Rice, MD, MSc23Christopher B. Thomas, MD241 Pulmonary and Critical Care, Louisiana State University Health Sciences Center, Baton Rouge, LA3 Cytovale, Inc, San Francisco, CA.4 Pulmonary & Critical Care, University Medical Center, New Orleans, LA.5 Pulmonary and Critical Care, Kootenai Health, Coeur d’Alene, ID.1 Pulmonary and Critical Care, Louisiana State University Health Sciences Center, Baton Rouge, LA1 Pulmonary and Critical Care, Louisiana State University Health Sciences Center, Baton Rouge, LA6 Department of Emergency Medicine, University of Washington, Seattle, WA.6 Department of Emergency Medicine, University of Washington, Seattle, WA.7 Departments of Emergency Medicine, Epidemiology and Prevention, and Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC.8 Critical Care Medicine and Infectious Diseases, University of Maryland—Baltimore Washington Medical Center, Glen Burnie, MD.10 Department of Emergency Medicine, University of Missouri School of Medicine, Columbia, MO.11 Pulmonary and Critical Care Medicine, Wake Forest University School of Medicine, Winston Salem, NC.12 Department of Medicine, Meharry School of Medicine, Nashville, TN.13 Allergy, Pulmonary, and Critical Care Medicine, Emory University School of Medicine, Atlanta, GA.14 Pulmonary and Critical Care, Bon Secours Mercy Health System, Richmond, VA.15 Department of Medicine, Infectious Disease, Creighton University School of Medicine, Phoenix, AZ.16 Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.17 Division of Trauma, Critical Care, and Acute Care Surgery, Medical College of Wisconsin, Milwaukee, WI.18 Critical Care Medicine, National Institutes of Health, Bethesda, MD.19 Department of Pathology, Medical College of Wisconsin, Milwaukee, WI.3 Cytovale, Inc, San Francisco, CA.2 Pulmonary & Critical Care, Our Lady of the Lake Regional Medical Center, Baton Rouge, LA.20 Department of Bioengineering and Biomedical Engineering, University of California, Los Angeles, CA.21 Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN.1 Pulmonary and Critical Care, Louisiana State University Health Sciences Center, Baton Rouge, LAOBJECTIVES:. To 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. DESIGN:. Prospective cohort study. SETTING:. Five 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. INTERVENTIONS:. All 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 RESULTS:. Of 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. CONCLUSIONS:. Increasing ISI interpretation band is associated with increasing probability of sepsis in patients presenting to the ED with suspected infection.http://journals.lww.com/10.1097/CCE.0000000000001026 |
| spellingShingle | Hollis R. O’Neal, Jr, MD, MSc Roya Sheybani, PhD David R. Janz, MD, MSc Robert Scoggins, MD, PhD Tonya Jagneaux, MD James E. Walker, MD, PhD Daniel J. Henning, MD, MPH Elizabeth Rosenman, MD Simon A. Mahler, MD, MS Hariharan Regunath, MD Christopher S. Sampson, MD D. Clark Files, MD Richard D. Fremont, MD Michael J. Noto, MD, PhD Erica E. Schneider, MD Wesley R. Shealey, MD Matthew S. Berlinger, MD Thomas C. Carver, MD Morgan K. Walker, MD Nathan A. Ledeboer, PhD Ajay M. Shah, PhD Henry T.K. Tse, PhD Dino DiCarlo, PhD Todd W. Rice, MD, MSc Christopher B. Thomas, MD Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use Critical Care Explorations |
| title | Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use |
| title_full | Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use |
| title_fullStr | Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use |
| title_full_unstemmed | Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use |
| title_short | Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use |
| title_sort | validation of a novel rapid sepsis diagnostic for emergency department use |
| url | http://journals.lww.com/10.1097/CCE.0000000000001026 |
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