Rapid and Robust Identification of Sepsis Using SeptiCyte RAPID in a Heterogeneous Patient Population.
Balk R., Esper AM., Martin GS., Miller RR., Lopansri BK., Burke JP., Levy M., Rothman RE., D'Alessio FR., Sidhaye VK., Aggarwal NR., Greenberg JA., Yoder M., Patel G., Gilbert E., Parada JP., Afshar M., Kempker JA., van der Poll T., Schultz MJ., Scicluna BP., Klein Klouwenberg PMC., Liebler J., Blodget E., Kumar S., Mei XW., Navalkar K., Yager TD., Sampson D., Kirk JT., Cermelli S., Davis RF., Brandon RB.
Background/Objective: SeptiCyte RAPID is a transcriptional host response assay that discriminates between sepsis and non-infectious systemic inflammation (SIRS) with a one-hour turnaround time. The overall performance of this test in a cohort of 419 patients has recently been described [Balk et al., J Clin Med 2024, 13, 1194]. In this study, we present the results from a detailed stratification analysis in which SeptiCyte RAPID performance was evaluated in the same cohort across patient groups and subgroups encompassing different demographics, comorbidities and disease, sources and types of pathogens, interventional treatments, and clinically defined phenotypes. The aims were to identify variables that might affect the ability of SeptiCyte RAPID to discriminate between sepsis and SIRS and to determine if any patient subgroups appeared to present a diagnostic challenge for the test. Methods: (1) Subgroup analysis, with subgroups defined by individual demographic or clinical variables, using conventional statistical comparison tests. (2) Principal component analysis and k-means clustering analysis to investigate phenotypic subgroups defined by unique combinations of demographic and clinical variables. Results: No significant differences in SeptiCyte RAPID performance were observed between most groups and subgroups. One notable exception involved an enhanced SeptiCyte RAPID performance for a phenotypic subgroup defined by a combination of clinical variables suggesting a septic shock response. Conclusions: We conclude that for this patient cohort, SeptiCyte RAPID performance was largely unaffected by key variables associated with heterogeneity in patients suspected of sepsis.