Department of Neurology, University Hospital Ostrava, Ostrava, Czech Republic; Centre of Clinical Neurosciences, University of Ostrava, Ostrava, Czech Republic.
Institute of Laboratory Medicine, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic; Institute of Laboratory Medicine, University Hospital Ostrava, Ostrava, Czech Republic.
Mult Scler Relat Disord. 2024 Oct;90:105815. doi: 10.1016/j.msard.2024.105815. Epub 2024 Aug 11.
The gold standard for serum neurofilament light chain (sNfL) determination is the single molecule array (SIMOA), the use of which is limited by availability and cost. The VEUS method is a fully automated, user-friendly diagnostic system requiring no sample preparation, with high reported sensitivity, multiplexing capability, and rapid diagnostics. The aim of this study was to compare the SIMOA and VEUS methods for determining sNfL levels in patients with multiple sclerosis (MS).
A single-centre cross-sectional study was conducted at the MS Centre of University Hospital Ostrava. Patients were enrolled in the study from January 18 to January 31, 2024. Inclusion criteria were: 1) diagnosis of MS according to the revised 2017 McDonald criteria, 2) age ≥18 years, and 3) signed informed consent. The NF-light V2 diagnostic kit (SIMOA, Quanterix) and the Singleplex Neurology assay kit (VEUDx, EZDiatech) were used to determine sNfL concentrations. The two methods were compared by use of Spearman correlation, Passing-Bablok regression, and Bland-Altman analysis.
A total of 49 patients were included in the study, of whom 39 (79.6 %) were female. The median sNfL concentration was 7.73 (IQR 5.80-9.93) ng/L determined by SIMOA and 1.31 (IQR 1.18-1.65) ng/L by VEUS. We did not find a correlation between SIMOA and VEUS (r = 0.025, p = 0.866). Passing-Bablok regression demonstrated a systematic and proportional difference between the two methods. A significant disagreement between them was also confirmed by the Bland-Altman plots. On average, sNfL values measured by SIMOA were 3.56 ng/L (95 % CI 0.78 to 6.34) higher than those measured by VEUS.
Our investigation uncovered noteworthy disparities between the SIMOA and VEUS techniques in determining sNfL levels. Specifically, the VEUS technique systematically produces lower estimates of sNFL levels. This substantial variance emphasizes the importance of carefully evaluating assay methods when quantifying sNfL.
血清神经丝轻链（sNfL）的金标准测定方法是单分子阵列（SIMOA），但其可用性和成本限制了其使用。VEUS 方法是一种全自动、用户友好的诊断系统，无需样品制备，具有高灵敏度、多重检测能力和快速诊断的特点。本研究旨在比较 SIMOA 和 VEUS 方法在多发性硬化症（MS）患者中测定 sNfL 水平的应用。
这是一项在奥斯特拉瓦大学医院 MS 中心进行的单中心横断面研究。2024 年 1 月 18 日至 1 月 31 日期间，患者被纳入该研究。纳入标准为：1）根据修订后的 2017 年 McDonald 标准诊断为 MS；2）年龄≥18 岁；3）签署知情同意书。使用 NF-light V2 诊断试剂盒（SIMOA，Quanterix）和单plex 神经测定试剂盒（VEUDx，EZDiatech）测定 sNfL 浓度。使用 Spearman 相关分析、Passing-Bablok 回归和 Bland-Altman 分析比较两种方法。
共有 49 名患者入组研究，其中 39 名（79.6%）为女性。SIMOA 测定的 sNfL 浓度中位数为 7.73（IQR 5.80-9.93）ng/L，VEUS 测定的 sNfL 浓度中位数为 1.31（IQR 1.18-1.65）ng/L。我们没有发现 SIMOA 和 VEUS 之间的相关性（r=0.025，p=0.866）。Passing-Bablok 回归显示两种方法之间存在系统和比例差异。Bland-Altman 图也证实了它们之间存在显著的不一致。平均而言，SIMOA 测定的 sNfL 值比 VEUS 测定的 sNfL 值高 3.56ng/L（95%CI 0.78-6.34）。
我们的研究发现，SIMOA 和 VEUS 两种方法在测定 sNfL 水平方面存在显著差异。具体来说，VEUS 技术系统地产生较低的 sNFL 水平估计值。这种显著的差异强调了在定量 sNfL 时仔细评估检测方法的重要性。
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