Gant Kanegusuku Anastasia, Carll Timothy, Yeo Kiang-Teck J
Department of Pathology, University of Chicago, Chicago, IL, US.
Pritzker School of Medicine, University of Chicago, Chicago, IL, US.
Lab Med. 2025 Mar 10;56(2):129-135. doi: 10.1093/labmed/lmae064.
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.
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.
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%.
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.
白细胞介素-6（IL-6）是一种促炎细胞因子，与多种炎症性疾病相关。本验证研究评估了罗氏Elecsys IL-6电化学发光免疫分析方法，该方法已获得美国食品药品监督管理局的紧急使用授权。
对Elecsys IL-6分析方法的精密度、线性、干扰（由血红蛋白、胆红素、甘油三酯和生物素引起）进行评估，并将临床性能与由参考实验室执行的V-PLEX人IL-6免疫分析方法（Meso Scale Discovery）进行比较。
Elecsys IL-6分析方法精密度高（批内变异系数[CV]<3%，批间CV<5%），分析测量范围为1.5 - 4790 pg/mL，并且能耐受显著干扰（血红蛋白<2522、胆红素<62、甘油三酯<2101、生物素<50 ng/mL）。与V-PLEX分析方法比较显示，在评估IL-6浓度的患者样本中存在2.95的斜率偏差（n = 43，范围 = 1.5 - 1891 pg/mL，y = 2.95x - 32.7，r2 = 0.84）。Bland-Altman分析显示绝对平均偏差为152 pg/mL（标准差 = 254 pg/mL），或平均百分比差异为73%。
罗氏IL-6分析方法显示出良好的分析性能。与另一种参考方法相比存在较大的系统偏差，这使得不能使用多种方法来监测IL-6反应。罗氏平台上自动化IL-6分析方法的随机检测特性使得该检测可按需进行。
