Diagnostic performance of Elecsys immunoassays for cerebrospinal fluid Alzheimer's disease biomarkers in a nonacademic, multicenter memory clinic cohort: The ABIDE project.
Diagnostic performance of Elecsys immunoassays for cerebrospinal fluid Alzheimer's disease biomarkers in a nonacademic, multicenter memory clinic cohort: The ABIDE project.
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DOI：
10.1016/j.dadm.2018.08.006
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
Teunissen CE
中科院分区：
文献类型：
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作者：
Willemse EAJ;van Maurik IS;Tijms BM;Bouwman FH;Franke A;Hubeek I;Boelaarts L;Claus JJ;Korf ESC;van Marum RJ;Roks G;Schoonenboom N;Verwey N;Zwan MD;Wahl S;van der Flier WM;Teunissen CE
我们在多中心诊断环境中比较了自动Elecsys和手动Innotest免疫测定脑脊液（CSF）阿尔茨海默病生物标志物。我们收集了来自8个当地记忆诊所的137名参与者的CSF样本。使用Innotest和Elecsys检测试剂盒集中分析淀粉样β（1-42）（Aβ42）、总tau（t-tau）和磷酸化tau（p-tau）。评估了方法之间的一致性。生物标志物结果在试验之间具有强相关性，Aβ42、t-tau和p-tau的斯皮尔曼ρ分别为0.94、0.98和0.98。使用高斯混合模型，Aβ42、t-tau和p-tau的队列特异性临界点估计分别为1092 pg/mL、235 pg/mL和24 pg/mL。我们发现，Aβ42和t-tau和p-tau检测之间生物标志物异常的一致性极佳，分别为97%和96%。在这个非学术性的多中心队列中，Elecsys和Innotest之间的高度一致性支持Elecsys用于CSF阿尔茨海默病诊断，并允许方法之间的结果转换。方法比较8个非学术记忆诊所收集的137份CSF样本。Innotest和Elecsys强相关：ρ = 0.94 Aβ42; 0.98 t-tau; 0.98 p-tau。生物标志物异常的一致性：97% Aβ42; 96% t-tau和p-tau。基于NIA-AA的阿尔茨海默病特征的一致性（Aβ42降低和p-tau升高）：89%。分析前方案偏离未显示对生物标志物相关性的影响。
We compared the automated Elecsys and manual Innotest immunoassays for cerebrospinal fluid (CSF) Alzheimer's disease biomarkers in a multicenter diagnostic setting. We collected CSF samples from 137 participants in eight local memory clinics. Amyloid β(1–42) (Aβ42), total tau (t-tau), and phosphorylated tau (p-tau) were centrally analyzed with Innotest and Elecsys assays. Concordances between methods were assessed. Biomarker results strongly correlated between assays with Spearman's ρ 0.94 for Aβ42, 0.98 for t-tau, and 0.98 for p-tau. Using Gaussian mixture modeling, cohort-specific cut-points were estimated at 1092 pg/mL for Aβ42, 235 pg/mL for t-tau, and 24 pg/mL for p-tau. We found an excellent concordance of biomarker abnormality between assays of 97% for Aβ42 and 96% for both t-tau and p-tau. The high concordances between Elecsys and Innotest in this nonacademic, multicenter cohort support the use of Elecsys for CSF Alzheimer's disease diagnostics and allow conversion of results between methods. Method comparison of 137 CSF samples collected in eight nonacademic memory clinics. Innotest and Elecsys strongly correlated: ρ = 0.94 Aβ42; 0.98 t-tau; 0.98 p-tau. Concordances of biomarker abnormalities: 97% Aβ42; 96% t-tau and p-tau. Concordance of NIA-AA–based Alzheimer's disease profile (Aβ42 decreased and p-tau increased): 89%. Preanalytical protocol deviations did not show effects on biomarker correlations.