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Comparison of neurofilament light chain results between two independent facilities
BMJ Neurology Open ( IF 2.1 ) Pub Date : 2020-10-01 , DOI: 10.1136/bmjno-2020-000063
Tobias Sejbaek 1, 2 , Jason P Mendoza 3 , Natasha Penner 3 , Jonna Skov Madsen 4, 5 , Dorte Aalund Olsen 5 , Zsolt Illes 6
Affiliation  

Objectives To examine levels of neurofilament light chain (NFL) in identical cerebrospinal fluid (CSF) and blood samples at two different facilities, and how differences affect interpretation of levels within and above the normal range. Methods CSF and plasma from patients with multiple sclerosis (MS) and healthy controls (HCs) were analysed by Simoa (Quanterix) for levels of NFL providing a total of 165 CSF samples (119 from MS) and 225 plasma samples (180 from MS). Results CSF and plasma concentrations highly correlated between NFL laboratory facilities (R: 0.92 and 0.84, <0.0001, respectively), and there were no differences between facilities. A bias between the two sites for plasma was −0.95 pg/mL and for CSF −73.53 pg/mL. The cut-offs for CSF were 807.5 and 571.0 pg/mL at site 1 and site 2, respectively; the cut-offs for plasma were 13.0 and 11.8 pg/mL, respectively. Seven out of 180 plasma samples (3.9%) and 3 out of 119 CSF samples (2.5%) from MS patients could be reclassified as normal/abnormal, that is, below/above cut-off, when measured at different facilities. Conclusion Our study demonstrates that results of NFL in CSF and blood measured with SIMOA are comparable between facilities. Nevertheless, healthcare practitioners should consider reference values at different laboratories, since different sensitivity/specificity can affect interpretation when low values are adjacent to cut-offs.

中文翻译:

两个独立设施之间神经丝轻链结果的比较

目的 检查两个不同设施的相同脑脊液 (CSF) 和血液样本中的神经丝轻链 (NFL) 水平,以及差异如何影响对正常范围内和以上水平的解释。方法 通过 Simoa (Quanterix) 分析来自多发性硬化症 (MS) 和健康对照 (HC) 患者的 CSF 和血浆的 NFL 水平,提供总共 165 个 CSF 样本(119 个来自 MS)和 225 个血浆样本(180 个来自 MS) . 结果 NFL 实验室设施之间的 CSF 和血浆浓度高度相关(R:分别为 0.92 和 0.84,<0.0001),设施之间没有差异。血浆的两个部位之间的偏差为 -0.95 pg/mL,CSF 的偏差为 -73.53 pg/mL。站点 1 和站点 2 的 CSF 临界值分别为 807.5 和 571.0 pg/mL;血浆的临界值为 13。分别为 0 和 11.8 pg/mL。来自 MS 患者的 180 个血浆样本中的 7 个 (3.9%) 和 119 个 CSF 样本中的 3 个 (2.5%) 可以重新分类为正常/异常,即在不同设施测量时低于/高于截止值。结论 我们的研究表明,使用 SIMOA 测量的 CSF 和血液中的 NFL 结果在设施之间具有可比性。然而,医疗保健从业者应考虑不同实验室的参考值,因为当低值与临界值相邻时,不同的敏感性/特异性会影响解释。结论 我们的研究表明,使用 SIMOA 测量的 CSF 和血液中的 NFL 结果在设施之间具有可比性。然而,医疗保健从业者应考虑不同实验室的参考值,因为当低值与临界值相邻时,不同的敏感性/特异性会影响解释。结论 我们的研究表明,使用 SIMOA 测量的 CSF 和血液中的 NFL 结果在设施之间具有可比性。然而,医疗保健从业者应考虑不同实验室的参考值,因为当低值与临界值相邻时,不同的敏感性/特异性会影响解释。
更新日期:2020-10-19
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