Development and Validation of a Cellular Host Response Test as an Early Diagnostic for Sepsis
Abstract
Sepsis must be diagnosed quickly to avoid morbidity and mortality. However, the clinical manifestations of sepsis are highly variable and emergency department (ED) clinicians often must make rapid, impactful decisions before laboratory results are known. We previously developed a technique that allows the measurement of the biophycial properties of white blood cells as they are stretched through a microfluidic channel. In this study we describe and validate the resultant output as a model and score - the IntelliSep Index (ISI) - that aids in the diagnosis of sepsis in patients with suspected or confirmed infection from a single blood draw performed at the time of ED presentation. The final model was trained and cross-validated on a high acuity cohort with a 23.5% sepsis incidence (n=307), and the performance and generalizability of the model was evaluated on a separate low acuity cohort with a 6.4% sepsis incidence (n=94) and healthy donors (n=72). The ISI agreed with the diagnosis established by retrospective physician adjudication.