Objectives: Significantly elevated levels of neurofilament light chain (NfL) and phosphorylated neurofilament heavy chain (pNfH) have been described in the blood and cerebrospinal fluid (CSF) of amyotrophic lateral sclerosis (ALS) patients. The aim of this study was to evaluate the analytical performance of different neurofilament assays in a round robin with 10 centers across Europe/U.S. Methods: Serum, plasma and CSF samples from a group of five ALS and five neurological control patients were distributed across 10 international specialist neurochemical laboratories for analysis by a range of commercial and in-house neurofilament assays. The performance of all assays was evaluated for their ability to differentiate between the groups. The inter-assay coefficient of variation was calculated where appropriate from sample measurements performed across multiple laboratories using the same assay. Results: All assays could differentiate ALS patients from controls in CSF. Inter-assay coefficient of variation of analytical platforms performed across multiple laboratories varied between 6.5% and 41.9%. Conclusions: This study is encouraging for the growing momentum toward integration of neurofilament measurement into the specialized ALS clinic. It demonstrates the importance of ‘round robin’ studies necessary to ensure the analytical quality required for translation to the routine clinical setting. A standardized neurofilament probe is needed which can be used as international benchmark for analytical performance in ALS.

目的：在肌萎缩侧索硬化 (ALS) 患者的血液和脑脊液 (CSF) 中，神经丝轻链 (NfL) 和磷酸化神经丝重链 (pNfH) 水平显着升高。这项研究的目的是与欧洲/美国的10个中心，以评估在循环赛不同的神经丝试验的分析性能的方法：来自 5 名 ALS 患者和 5 名神经系统控制患者的血清、血浆和 CSF 样本分布在 10 个国际专业神经化学实验室，用于通过一系列商业和内部神经丝检测进行分析。评估了所有测定的性能以区分各组的能力。在适当的情况下，从使用相同检测的多个实验室进行的样品测量计算检测间变异系数。结果：所有测定都可以将 ALS 患者与 CSF 中的对照区分开来。跨多个实验室进行的分析平台的测定间变异系数在 6.5% 到 41.9% 之间变化。结论：这项研究令人鼓舞的是，将神经丝测量整合到专门的 ALS 诊所的势头越来越大。它证明了确保转化为常规临床环境所需的分析质量所必需的“循环”研究的重要性。需要一个标准化的神经丝探针，它可以用作 ALS 分析性能的国际基准。