Derivation of cutoffs for the Elecsys(®) amyloid β (1-42) assay in Alzheimer's disease.
Derivation of cutoffs for the Elecsys(®) amyloid β (1-42) assay in Alzheimer's disease.
复制标题
elecsys（®）淀粉样β（1-42）测定阿尔茨海默氏病的临界值的推导。
DOI：
10.1016/j.dadm.2018.07.002
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
Dean RA
中科院分区：
文献类型：
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作者：
Shaw LM;Waligorska T;Fields L;Korecka M;Figurski M;Trojanowski JQ;Eichenlaub U;Wahl S;Quan M;Pontecorvo MJ;Lachno DR;Talbot JA;Andersen SW;Siemers ER;Dean RA
研究了用于阿尔茨海默病患者分类的Elecsys®淀粉样蛋白β（Aβ [1-42]）免疫测定临界值。通过Elecsys®免疫测定分析从患有轻度至中度阿尔茨海默病的患者收集的脑脊液样品：（1）Aβ（1-42），（2）总tau，和（3）磷酸化tau。通过AlzBio 3（n = 206）、混合建模（n = 216）和与florbetapir F18成像分类（n = 75）的一致性之间的方法比较，估计临界值（Aβ [1-42]和与tau的比值）。Elecsys® Aβ（1-42）临界值为1065-pg/mL（95%置信区间：985-1153），与AlzBio 3的总体一致率为94%。可比截止估计数（95%置信区间）来源于混合建模（等加权：1017 [949-1205] pg/mL;患病率加权：1172 [1081-1344] pg/mL）和与florbetapir F 18成像的一致性（目视读数：1198 [998-1591] pg/mL;自动读数：1198 [1051-1638] pg/mL）。基于三种方法，1100-pg/mL Elecsys® Aβ（1-42）临界值适用于具有相似人群和分析前处理的临床试验。生物标志物可以促进适当的患者招募到临床试验中。β淀粉样蛋白测量可以帮助鉴别淀粉样蛋白阳性患者。类似的截止估计值来自三种不同的方法。
An Elecsys® Amyloid β (Aβ [1–42]) immunoassay cutoff for classification of patients with Alzheimer's disease was investigated. Cerebrospinal fluid samples collected from patients with mild-to-moderate Alzheimer's disease were analyzed by Elecsys® immunoassays: (1) Aβ (1–42), (2) total tau, and (3) phosphorylated tau. Cutoffs (Aβ [1–42] and ratios with tau) were estimated by method comparison between AlzBio3 (n = 206), mixture modeling (n = 216), and concordance with florbetapir F 18 imaging-based classification (n = 75). A 1065-pg/mL (95% confidence interval: 985–1153) Elecsys® Aβ (1–42) cutoff provided 94% overall percentage agreement with AlzBio3. Comparable cutoff estimates (95% confidence interval) were derived from mixture modeling (equally weighted: 1017 [949–1205] pg/mL; prevalence weighted: 1172 [1081–1344] pg/mL) and concordance with florbetapir F 18 imaging (visual read: 1198 [998–1591] pg/mL; automated: 1198 [1051–1638] pg/mL). Based on three approaches, a 1100-pg/mL Elecsys® Aβ (1–42) cutoff is suitable for clinical trials with similar populations and preanalytical handling. Biomarkers can facilitate appropriate patient recruitment into clinical trials. Amyloid beta measurement can aid the identification of amyloid-positive patients. Similar cutoff estimates were derived by three different approaches.