From the Department of Pediatrics, Section of Allergy and Immunology, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (Knight).
Department of Biostatistics, College of American Pathologists, Northfield, Illinois (Long).
Arch Pathol Lab Med. 2020 Oct 1;144(10):1230-1233. doi: 10.5858/arpa.2019-0519-CP.
CONTEXT.—: The measurement of cytokines in clinical laboratories is becoming an increasingly routine part of immune monitoring when administering biologic and cell-based immunotherapies and also for clinical assessment of inflammatory conditions. While a number of commercial assays and platforms are available for cytokine measurement, there is currently little standardization among these analytical methods.
OBJECTIVE.—: To characterize the variability and comparability among cytokine testing platforms that are commonly used in clinical laboratories.
DESIGN.—: We analyzed data for 4 cytokines (interleukin [IL]-1, IL-6, IL-8, and tumor necrosis factor-alpha [TNF-α]) from 6 College of American Pathologists cytokine surveys administered from 2015 to 2018. Analyses interrogated variability between testing methods and variability within each laboratory across the mailings.
RESULTS.—: Significant variability was noted across methods with analysis of IL-1 showing the least variability and IL-6, IL-8, and TNF-α varying between methods to a greater extent. Intralab variability was also significant with TNF-α measurements again showing the greatest variability.
CONCLUSIONS.—: This retrospective analysis of College of American Pathologists proficiency testing data for cytokine measurement is the largest method comparison to date, and this study provides a description of the variation of cytokine measurement across methods, across laboratories, and within laboratories. Serial monitoring of cytokines should preferentially be performed by the same method within the same laboratory.
在使用生物和基于细胞的免疫疗法进行免疫监测时，以及在对炎症性疾病进行临床评估时，临床实验室中细胞因子的测量正成为越来越常规的部分。虽然有许多商业检测方法和平台可用于细胞因子测量，但这些分析方法之间目前几乎没有标准化。
描述在临床实验室中常用的细胞因子检测平台之间的可变性和可比性。
我们分析了 2015 年至 2018 年期间进行的 6 次美国病理学家学院细胞因子调查中 4 种细胞因子（白细胞介素[IL]-1、IL-6、IL-8 和肿瘤坏死因子-α[TNF-α]）的数据。分析询问了测试方法之间的变异性和每个实验室在邮件中的变异性。
方法之间存在显著的可变性，分析表明 IL-1 的可变性最小，而 IL-6、IL-8 和 TNF-α 的可变性在方法之间变化更大。实验室内部的可变性也很显著，TNF-α 的测量再次显示出最大的可变性。
这是对细胞因子测量的美国病理学家学院能力验证数据的回顾性分析，是迄今为止最大的方法比较研究，本研究描述了细胞因子测量在方法之间、实验室之间和实验室内部的变化。细胞因子的连续监测应优先在同一实验室中使用相同的方法进行。
