Cytovale announced the publication of a new peer reviewed-study in "Academic Emergency Medicine'' that demonstrates strong diagnostic performance of the company's IntelliSep host response test for sepsis detection.
The study analyzed 1,002 patients and evaluated the accuracy of IntelliSep to rapidly diagnose patients with sepsis and help clinicians expedite appropriate care.
The IntelliSep test is U.S. Food and Drug Administration (FDA)-cleared for detecting sepsis in an adult population that presents with signs and symptoms of infection to the Emergency Department. The test provides new information about immune activation and sepsis risk stratification through a simple blood draw in about 8 minutes.
This study is a pooled analysis of 1,002 patients composed of five distinct, but similar, adult cohorts who presented in seven geographically diverse EDs across the U.S. with signs or suspicion of infection. IntelliSep was evaluated for accurately diagnosing sepsis and providing a rapid, objective tool for determining the risk and severity of sepsis in these patients. Among the findings, key highlights include:
- IntelliSep demonstrated 'rule-out' performance related to sepsis, with a Negative Predictive Value of 97.5%, which, combined with the 0.0% sepsis mortality rate for patients with low risk scores, may allow the care team to explore alternative diagnoses in low risk patients.
- The test showed similar 'rule-in' performance to other critical ED tests, with a Positive Predictive Value of 55%.
- More than 50% of the patients observed were classified by the IntelliSep test as having a low risk of sepsis, yet, the number of these patients treated with antibiotics was comparable to the number of patients treated with antibiotics that received a high risk score.
