Validation data presented for Cytovale sepsis diagnostic test

Diagnose Sepsis Social

A critical care physician has presented validation data for a U.S. Food and Drug Administration (FDA)-cleared rapid diagnostic test used in emergency departments to detect sepsis.

The test, IntelliSep, was developed by San Francisco-based Cytovale, and the validation data presented at the American Thoracic Society’s 2023 International Conference, held in Washington, DC, from May 19 to May 24.

Dr. Hollis O'Neal, the presenter, is a critical care physician and associate professor of medicine at LSU Health New Orleans School of Medicine’s Baton Rouge, LA campus. To assess the IntelliSep Test, he led a prospective, multicenter study of adults presenting to the emergency department with signs or suspicion of infection.

Sepsis is an unpredictable whole-body immune response to bacterial infection, viral infection, or fungal infection that can progress rapidly. Without prompt treatment, sepsis can lead to tissue damage, organ failure, and death.

This serious condition is a primary reason for hospital readmittance, and a leading cause of hospital deaths. Many patients who survive severe sepsis recover completely, but some are left with permanent organ damage.

According to the Centers for Disease Control and Prevention (CDC), each year at least 1.7 million U.S. adults develop sepsis, and nearly 270,000 die from it. These numbers are on the rise.

IntelliSep is a microfluidic test that measures the biophysical properties of white blood cells, called leukocytes, in conjunction with other laboratory findings and clinical assessments to aid in early sepsis detection. In less than 10 minutes, it provides a test result, called the IntelliSep Index, shown in three interpretative bands, ranging from a low probability of sepsis (Band 1) to a high probability of sepsis (Band 3).

In the prospective, multicenter study, the IntelliSep results were compared to retrospective judgment of septic shock — life-threatening organ dysfunction — by an independent panel of critical care, infectious disease, and emergency medicine physicians. IntelliSep Index results were blinded from research and clinical personnel, and clinical outcomes were extracted from medical records.

A total of 572 patients were enrolled in medical center emergency departments in four states. Sepsis was the final diagnosis in 152 patients (26.6%). The prevalence of sepsis in Band 3 was 79 of 160 (49.4%); in Band 2 it was 45 of 160 (28.12%); and in Band 1 it was 28 of 252 (11.1%). Emergency department physicians diagnosed sepsis in 52 of 152 patients with sepsis and 24 of 420 patients without sepsis.

According to O'Neal, the study showed that the IntelliSep Index provided a rapid, reliable diagnostic aid for sepsis in patients with signs of infection. If integrated into a process of clinical decision-making, the IntelliSep Index could improve the efficiency and efficacy of sepsis care in emergency departments.

Based on the study data, the FDA granted the system 510k clearance in December of 2022.

“Every minute counts when it comes to sepsis diagnosis, and emergency departments operate under major time and resource constraints that could impact patient outcomes,” O'Neal said in a statement. “These results validate the efficacy and efficiency of IntelliSep as a diagnostic aid that may improve sepsis triage when incorporated into existing clinical protocols.”

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