Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA; Knight Alzheimer Disease Research Center, Washington University School of Medicine, St. Louis, MO, USA; Hope Center for Neurological Disorders, Washington University School of Medicine, St. Louis, MO, USA.
Neurochemistry Laboratory, Department of Clinical Chemistry, VU Medical Center, Amsterdam, The Netherlands.
Alzheimers Dement. 2018 Jan;14(1):62-70. doi: 10.1016/j.jalz.2017.06.2264. Epub 2017 Jul 12.
The best-established cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease are levels of amyloid β 42 (Aβ42), total tau (tau), and phosphorylated tau 181 (ptau). We examined whether a widely used commercial immunoassay for CSF Aβ42, tau, and ptau provided stable measurements for more than ∼10 years.
INNOTEST assay values for CSF Aβ42, tau, and ptau from Washington University in St. Louis and VU Medical Center, Amsterdam, were evaluated.
Aβ42 values as measured by the INNOTEST assay drifted upward by approximately 3% per year over the past decade. Tau values remained relatively stable, whereas results for ptau were mixed.
Assay drift may reduce statistical power or even confound analyses. The drift in INNOTEST Aβ42 values may reduce diagnostic accuracy for Alzheimer's disease in the clinic. We recommend methods to account for assay drift in existing data sets and to reduce assay drift in future studies.
目前,被广泛认可的用于诊断阿尔茨海默病的脑脊液(CSF)生物标志物为β淀粉样蛋白 42(Aβ42)、总 tau(tau)和磷酸化 tau 181(ptau)的水平。本研究旨在检验一种被广泛应用于 CSF 中 Aβ42、tau 和 ptau 检测的商业免疫分析方法是否能够提供超过 10 年的稳定测量。
我们评估了来自华盛顿大学圣路易斯分校和阿姆斯特丹 VU 医学中心的 INNOTEST 检测 CSF 中 Aβ42、tau 和 ptau 的结果。
在过去的十年中,INNOTEST 检测的 Aβ42 值每年大约向上漂移 3%。tau 值相对稳定,而 ptau 的检测结果则较为混杂。
检测漂移可能会降低统计学效力,甚至会混淆分析。INNOTEST Aβ42 值的漂移可能会降低该检测方法在临床上对阿尔茨海默病的诊断准确性。我们建议采用方法来校正现有数据集的检测漂移,并减少未来研究中的检测漂移。