Balk Robert, Esper Annette M, Martin Greg S, Miller Russell R, Lopansri Bert K, Burke John P, Levy Mitchell, Rothman Richard E, D'Alessio Franco R, Sidhaye Venkataramana K, Aggarwal Neil R, Greenberg Jared A, Yoder Mark, Patel Gourang, Gilbert Emily, Parada Jorge P, Afshar Majid, Kempker Jordan A, van der Poll Tom, Schultz Marcus J, Scicluna Brendon P, Klein Klouwenberg Peter M C, Liebler Janice, Blodget Emily, Kumar Santhi, Mei Xue W, Navalkar Krupa, Yager Thomas D, Sampson Dayle, Kirk James T, Cermelli Silvia, Davis Roy F, Brandon Richard B
Rush Medical College and Rush University Medical Center, Chicago, IL 60612, USA.
Grady Memorial Hospital and Emory University School of Medicine, Atlanta, GA 30322, USA.
J Clin Med. 2024 Oct 10;13(20):6044. doi: 10.3390/jcm13206044.
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. (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. 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. We conclude that for this patient cohort, SeptiCyte RAPID performance was largely unaffected by key variables associated with heterogeneity in patients suspected of sepsis.
SeptiCyte RAPID是一种转录宿主反应检测方法，可在一小时内区分脓毒症和非感染性全身炎症反应（SIRS）。最近已报道了该检测方法在419名患者队列中的整体表现[Balk等人，《临床医学杂志》2024年，第13卷，第1194页]。在本研究中，我们展示了详细分层分析的结果，其中在同一队列中，针对涵盖不同人口统计学特征、合并症和疾病、病原体来源和类型、介入治疗以及临床定义表型的患者组和亚组，评估了SeptiCyte RAPID的性能。目的是确定可能影响SeptiCyte RAPID区分脓毒症和SIRS能力的变量，并确定是否有任何患者亚组对该检测构成诊断挑战。（1）使用传统统计比较检验，按个体人口统计学或临床变量定义亚组进行亚组分析。（2）主成分分析和k均值聚类分析，以研究由人口统计学和临床变量的独特组合定义的表型亚组。大多数组和亚组之间未观察到SeptiCyte RAPID性能的显著差异。一个显著例外是，对于由提示脓毒性休克反应的临床变量组合定义的表型亚组，SeptiCyte RAPID性能有所增强。我们得出结论，对于该患者队列，SeptiCyte RAPID性能在很大程度上不受与疑似脓毒症患者异质性相关的关键变量影响。
