Validation of a host response assay, SeptiCyte LAB, for discriminating sepsis from systemic inflammatory response syndrome in the ICU

Rationale: A molecular test to distinguish between sepsis and systemic inflammation of non-infectious etiology could potentially have clinical utility. Objectives: This study evaluated the diagnostic performance of a molecular host response assay (SeptiCyte™ LAB) designed to distinguish between sepsis and non-infectious systemic inflammation in critically ill adults. Methods: The study employed a prospective, observational, non-interventional design, and recruited a heterogeneous cohort of adult critical care patients from seven sites in the USA (N=249). An additional group of 198 patients, recruited in the large MARS consortium trial in the Netherlands (clinicaltrials.gov identifier: NCT01905033), was also tested and analyzed, making a grand total of 447 patients in our study. Performance of SeptiCyte™ LAB was compared to retrospective physician diagnosis by a panel of three experts. Measurements and Main Results: In receiver operating characteristic curve analysis, SeptiCyte™ LAB had an estimated area u...