Analytical evaluation of the automated interleukin-6 assay on the Roche cobas e602 analyzer.

Anastasia Gant Kanegusuku, Timothy Carll, Kiang-Teck J Yeo
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Abstract

Background: Interleukin-6 (IL-6) is a proinflammatory cytokine that is associated with many inflammatory diseases. This validation study evaluates the automated Roche Elecsys IL-6 electrochemiluminescent immunoassay that has been granted emergency use authorization by the US Food and Drug Administration.

Methods: The Elecsys IL-6 assay was evaluated for precision, linearity, interference (by hemoglobin, bilirubin, triglycerides, and biotin) and clinical performance was compared to the V-PLEX Human IL-6 immunoassay (Meso Scale Discovery), performed by a reference laboratory.

Results: The Elecsys IL-6 assay is precise (intra-assay <3% coefficient of variation [CV], interassay <5% CV), exhibits an analytical measurable range of 1.5-4790 pg/mL, and is tolerant of significant interferences (H < 2522, I <62, L<2101, biotin <50 ng/mL). Comparison with the V-PLEX assay revealed a 2.95 slope bias in patient samples evaluated for IL-6 concentration (n = 43, range = 1.5-1891 pg/mL, y = 2.95x - 32.7, r2 = 0.84). Bland-Altman analysis revealed an absolute mean bias of 152 pg/mL (SD = 254 pg/mL), or a mean percentage difference of 73%.

Conclusion: The Roche IL-6 assay showed good analytical performance. The large systematic bias compared with another reference method precludes using multiple methods to monitor IL-6 response. The random-access nature of an automated IL-6 assay on the Roche platform makes the test available on demand.

对罗氏 cobas e602 分析仪上的自动白细胞介素-6 分析法进行分析评估。
背景:白细胞介素-6(IL-6)是一种促炎细胞因子,与许多炎症性疾病相关。本验证研究对已获得美国食品药品管理局紧急使用授权的罗氏 Elecsys IL-6 电化学发光免疫分析仪进行了评估:对Elecsys IL-6测定的精密度、线性、干扰(血红蛋白、胆红素、甘油三酯和生物素的干扰)和临床表现进行了评估,并与参考实验室进行的V-PLEX人IL-6免疫测定(Meso Scale Discovery)进行了比较:结果:Elecsys IL-6 检测法是精确的(检测内结论):罗氏 IL-6 检测法显示出良好的分析性能。与另一种参考方法相比,该方法存在较大的系统性偏差,因此不能使用多种方法监测 IL-6 反应。罗氏平台上的全自动 IL-6 检测试剂盒的随机接入特性使该检测试剂盒可按需使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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