Pan Catherine, Korff Ané, Galasko Douglas, Ginghina Carmen, Peskind Elaine, Li Ge, Quinn Joseph, Montine Thomas J, Cain Kevin, Shi Min, Zhang Jing
Department of Pathology, University of Washington School of Medicine, Seattle, WA, USA.
Department of Neurosciences, University of California at San Diego, San Diego, CA, USA.
J Alzheimers Dis. 2015;45(3):709-19. doi: 10.3233/JAD-143099.
Meso Scale Discovery (MSD) recently established electrochemiluminescence-based assays to measure cerebrospinal fluid (CSF) levels of total tau (t-tau) and amyloid-β 1-42 peptide (Aβ42) that can aid in the diagnosis of Alzheimer's disease (AD). The goal of this investigation is to independently evaluate this platform and establish cut-off values of these biomarkers for AD diagnosis.
To validate the analytical and clinical performance of the MSD t-tau and Aβ42 kits and propose diagnostic cut-off values for the field.
The analytical performance of the CSF t-tau and Aβ42 assays was determined, followed by assessment of diagnostic performance of CSF t-tau, Aβ42, and t-tau/Aβ42 in three clinically characterized cohorts.
Both MSD assays demonstrated consistent and stable analytical performance, as well as resistance to several important pre-analytic variables. Diagnostically, t-tau/Aβ42 performed the best.
Our results independently confirm the analytical and clinical performance of the MSD CSF t-tau and Aβ42 assays. Based on a large, multi-center, clinically-diagnosed cohort, we propose for the first time candidate diagnostic cut-offs for MSD measured CSF t-tau, Aβ42, and t-tau/Aβ42. However, these values needs to be refined as more subjects are included and the assays are tested by other laboratories.
中尺度发现公司（Meso Scale Discovery，MSD）最近建立了基于电化学发光的检测方法，用于测量脑脊液（CSF）中总tau蛋白（t-tau）和淀粉样β蛋白1-42肽（Aβ42）的水平，这有助于阿尔茨海默病（AD）的诊断。本研究的目的是独立评估该平台，并确定这些生物标志物用于AD诊断的临界值。
验证MSD公司t-tau和Aβ42检测试剂盒的分析性能和临床性能，并为该领域提出诊断临界值。
测定CSF中t-tau和Aβ42检测的分析性能，随后在三个具有临床特征的队列中评估CSF中t-tau、Aβ42和t-tau/Aβ42的诊断性能。
两种MSD检测方法均表现出一致且稳定的分析性能，以及对几个重要分析前变量的耐受性。在诊断方面，t-tau/Aβ42表现最佳。
我们的结果独立证实了MSD公司CSF中t-tau和Aβ42检测方法的分析性能和临床性能。基于一个大型多中心临床诊断队列，我们首次提出了MSD检测的CSF中t-tau、Aβ42和t-tau/Aβ42的候选诊断临界值。然而，随着纳入更多受试者并由其他实验室对检测方法进行测试这些值需要进一步完善。
