Multicenter validation of CSF neurofilaments as diagnostic biomarkers for ALS

Multicenter validation of CSF neurofilaments as diagnostic biomarkers for ALS
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DOI:
10.3109/21678421.2016.1167913
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发表时间:
2016-07-01
影响因子:
2.8
通讯作者:
Otto, Markus
Otto, Markus
中科院分区:
医学4区
文献类型:
--
作者:
Oeckl, Patrick;Jardel, Claude;Otto, Markus

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目的:神经丝是肌萎缩侧索硬化(ALS)的主要神经化学生物标志物。在这里,我们研究了分析前因素对脑脊液(CSF)中神经丝浓度的影响,在欧洲/美国的15个中心进行了反向循环。方法:ALS和对照患者(每个中心5/5,n=150)的样本进行了分析磷酸化神经丝重链(pNfH)和神经丝轻链(NfL)在两个实验室。研究结果:CSF pNfH升高(p568.5pg/mL),pNfH敏感性78.7%,特异性93.3%,NfL>1, 431 pg/mL敏感性79.0%,特异性86.4%。结论:ALS患者的值在大多数中心之间已经相当,支持最终实施为临床常规。然而,诊断检查中需要持续的质量控制程序。
OBJECTIVE: Neurofilaments are leading neurochemical biomarkers for amyotrophic lateral sclerosis (ALS). Here, we investigated the effect of preanalytical factors on neurofilament concentrations in cerebrospinal fluid (CSF) in a reverse round-robin with 15 centers across Europe/U.S. METHODS: Samples from ALS and control patients (5/5 each center, n=150) were analyzed for phosphorylated neurofilament heavy chain (pNfH) and neurofilament light chain (NfL) at two laboratories. RESULTS: CSF pNfH was increased (p568.5pg/mL for pNfH (sensitivity 78.7%, specificity 93.3%) and >1,431pg/mL for NfL (sensitivity 79.0%, specificity 86.4%). CONCLUSION: Values in ALS patients are already comparable between most centers, supporting eventual implementation into clinical routine. However, continuous quality control programs will be necessary for inclusion in the diagnostic work-up.