宿主反应检测试剂盒（SeptiCyte LAB）在 ICU 中鉴别脓毒症与全身炎症反应综合征的验证。
Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU.
机构信息
1 Intermountain Medical Center, Murray, Utah.
2 University of Utah School of Medicine, Salt Lake City, Utah.
出版信息
Am J Respir Crit Care Med. 2018 Oct 1;198(7):903-913. doi: 10.1164/rccm.201712-2472OC.
RATIONALE
A molecular test to distinguish between sepsis and systemic inflammation of noninfectious 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 noninfectious systemic inflammation in critically ill adults.
METHODS
The study employed a prospective, observational, noninterventional design and recruited a heterogeneous cohort of adult critical care patients from seven sites in the United States (n = 249). An additional group of 198 patients, recruited in the large MARS (Molecular Diagnosis and Risk Stratification of Sepsis) consortium trial in the Netherlands ( www.clinicaltrials.gov identifier NCT01905033), was also tested and analyzed, making a grand total of 447 patients in our study. The performance of SeptiCyte LAB was compared with 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 under the curve of 0.82-0.89 for discriminating sepsis from noninfectious systemic inflammation. The relative likelihood of sepsis versus noninfectious systemic inflammation was found to increase with increasing test score (range, 0-10). In a forward logistic regression analysis, the diagnostic performance of the assay was improved only marginally when used in combination with other clinical and laboratory variables, including procalcitonin. The performance of the assay was not significantly affected by demographic variables, including age, sex, or race/ethnicity.
CONCLUSIONS
SeptiCyte LAB appears to be a promising diagnostic tool to complement physician assessment of infection likelihood in critically ill adult patients with systemic inflammation. Clinical trial registered with www.clinicaltrials.gov (NCT01905033 and NCT02127502).
原理
一种能够区分脓毒症和非感染性病因所致全身性炎症的分子检测方法，有可能具有临床应用价值。
目的
本研究旨在评估一种旨在区分重症成人脓毒症和非感染性全身性炎症的分子宿主反应检测（SeptiCyte LAB）的诊断性能。
方法
本研究采用前瞻性、观察性、非干预性设计，从美国 7 个地点招募了一组异质的成年重症监护患者（n=249）。另外还招募了来自荷兰大型 MARS（脓毒症的分子诊断和风险分层）试验的 198 例患者（www.clinicaltrials.gov 标识符 NCT01905033），这使得我们的研究总共有 447 例患者。通过由三位专家组成的专家组对 SepiCyte LAB 的性能进行回顾性医师诊断进行比较。
测量和主要结果
在受试者工作特征曲线分析中，SeptiCyte LAB 用于区分脓毒症与非感染性全身性炎症的曲线下面积估计值为 0.82-0.89。随着检测评分（范围为 0-10）的增加，Sepsis 与非感染性全身性炎症的相对可能性增加。在前向逻辑回归分析中，当与其他临床和实验室变量（包括降钙素原）联合使用时，该检测的诊断性能仅略有改善。该检测的性能不受年龄、性别或种族/民族等人口统计学变量的显著影响。
结论
SepiCyte LAB 似乎是一种很有前途的诊断工具，可用于补充医师对有全身性炎症的重症成年患者感染可能性的评估。临床试验在 www.clinicaltrials.gov 注册（NCT01905033 和 NCT02127502）。
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