测定人血浆和脑脊液中的神经丝光:五种分析性免疫测定法的比较。

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Udit Sheth, Rebecca Harrison, Kyle Ferber, Erin G Rosenbaugh, Amanda Bevis, Rohini Khillan, Michael Benatar, Nicole L Bjorklund, Elena Di Daniel, Glenn A Harris, Olga I Kahn, Yongge Liu, Henrik Zetterberg, Laura L Mitic, Danielle Graham, Tania F Gendron
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引用次数: 0

摘要

目的:神经丝光(Neurofilament light, NfL)是神经系统疾病神经轴突损伤的生物流体标志物。目前已经开发了几种高通量、高灵敏度的免疫测定方法来定量血液和脑脊液(CSF)中的NfL,促进了NfL作为生物标志物在研究和临床实践中的应用。然而,由于缺乏对测定法的严格比较,很难确定数据是否具有可比性以及测定性能是否存在差异。在这里,我们比较了五种NfL免疫测定法的性能。方法:为了评估五种NfL免疫测定方法(Fujirebio、ProteinSimple、Quanterix、Roche和Siemens),我们使用汇集血浆或汇集CSF,以及来自20名健康对照和20名El Escorial定义的可能或确定肌萎缩侧索硬化症(ALS)患者的独特样本,以评估准确性、平行性和/或偏倚。我们还检查了血浆和脑脊液NfL浓度之间的相关性,并评估了它们区分健康人与ALS患者的能力。结果:基于我们对精密度和并行性的分析,五种测定法中的四种表现出示范性的性能。在这五项分析中,血浆中NfL浓度低于脑脊液,尽管它们显示出高度的相关性。我们注意到各试验的偏倚;血浆NfL浓度在Roche试验中最低,在ProteinSimple试验中最高。此外,使用血浆或脑脊液NfL,所有检测都能可靠地将健康对照与ALS患者区分开来。结论:四种NfL分析方法具有相似的分析性能。除了性能之外,还应该考虑其他因素,如成本、可访问性、可用性、占用空间和预期用途。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Measuring neurofilament light in human plasma and cerebrospinal fluid: a comparison of five analytical immunoassays.

Objectives: Neurofilament light (NfL) is an established biofluid marker of neuroaxonal injury for neurological diseases. Several high-throughput and sensitive immunoassays have been developed to quantify NfL in blood and cerebrospinal fluid (CSF), facilitating the use of NfL as a biomarker in research and clinical practice. However, because of the lack of rigorous comparisons of assays, it has been difficult to determine whether data are comparable and whether assay performance differs. Here, we compared the performance of five NfL immunoassays.

Methods: To assess the five NfL immunoassays (Fujirebio, ProteinSimple, Quanterix, Roche and Siemens), we used pooled plasma or pooled CSF, as well as unique samples from 20 healthy controls and 20 individuals with El Escorial defined probable or definite amyotrophic lateral sclerosis (ALS), to evaluate precision, parallelism and/or bias. We also examined correlations between plasma and CSF NfL concentrations within and across assays and evaluated their ability to differentiate healthy controls from individuals with ALS.

Results: Four of the five assays demonstrated exemplary performance based on our analyses of precision and parallelism. Across the five assays, NfL concentrations were lower in plasma than in CSF, although they displayed a high degree of correlation. We noted bias across assays; plasma NfL concentrations were lowest for the Roche assay and highest for the ProteinSimple assay. In addition, all assays reliably distinguished healthy controls from individuals with ALS using plasma or CSF NfL.

Conclusions: Four NfL assays demonstrated similar analytic performance. Alongside performance, other factors such as costs, accessibility, usability, footprint, and intended use, should be considered.

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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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