Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of β-amyloid (1-42) in human cerebrospinal fluid

被引：253

作者：

Bittner, Tobias ^{[1
]}

Zetterberg, Henrik ^{[2
,3
]}

Teunissen, Charlotte E. ^{[4
]}

Ostlund, Richard E., Jr. ^{[5
]}

Militello, Michael ^{[6
]}

Andreasson, Ulf ^{[2
]}

Hubeek, Isabelle ^{[4
]}

Gibson, David ^{[5
]}

Chu, David C. ^{[6
]}

Eichenlaub, Udo ^{[1
]}

Heiss, Peter ^{[1
]}

Kobold, Uwe ^{[1
]}

Leinenbach, Andreas ^{[1
]}

Madin, Kairat ^{[1
]}

Manuilova, Ekaterina ^{[1
]}

Rabe, Christina ^{[1
]}

Blennow, Kaj ^{[2
]}

机构：

[1] Roche Diagnost GmbH, Penzberg, Germany

[2] Univ Gothenburg, Clin Neurochem Lab, Inst Neurosci & Physiol, Sahlgrenska Acad, Molndal, Sweden

[3] UCL Inst Neurol, London, England

[4] Vrije Univ Amsterdam Med Ctr, Clin Chem, Amsterdam, Netherlands

[5] Washington Univ, Sch Med, St Louis, MO USA

[6] Covance Cent Lab Serv, Indianapolis, IN USA

来源：

ALZHEIMERS & DEMENTIA | 2016年 / 12卷 / 05期

关键词：

Amyloid; Amyloid-beta; 1-42; Alzheimer's disease; Assay; Biomarker; Cerebrospinal fluid; Dementia; Diagnosis; Electrochemiluminescence; Immunoassay; Method comparison; Precision; Repeatability; Reproducibility; Variability; POSTLUMBAR PUNCTURE HEADACHE; MODERATE ALZHEIMERS-DISEASE; CREUTZFELDT-JAKOB-DISEASE; PHOSPHORYLATED TAU; CLINICAL-PRACTICE; BIOMARKERS; DIAGNOSIS; DEMENTIA; RECOMMENDATIONS; QUANTIFICATION;

D O I：

10.1016/j.jalz.2015.09.009

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Introduction: Available assays for quantitation of the Alzheimer's disease (AD) biomarker amyloid-beta 1-42 (A beta [1-42]) in cerebrospinal fluid demonstrate significant variability and lack of standardization to reference measurement procedures (RMPs). We report analytical performance data for the novel Elecsys beta-amyloid (1-42) assay (Roche Diagnostics). Methods: Lot-to-lot comparability was tested using method comparison. Performance parameters were measured according to Clinical & Laboratory Standards Institute (CLSI) guidelines. The assay was standardized to a Joint Committee for Traceability in Laboratory Medicine (JCTLM) approved RMP. Results: Limit of quantitation was <11.28 pg/mL, and the assay was linear throughout the measuring range (200-1700 pg/mL). Excellent lot-to-lot comparability was observed (correlation coefficients [Pearson's, r] >0.995; bias in medical decision area <2%). Repeatability coefficients of variation (CVs) were 1.0%-1.6%, intermediate CVs were 1.9%-4.0%, and intermodule CVs were 1.1%-3.9%. Estimated total reproducibility was 2.0%-5.1%. Correlation with the RMP was good (Pearson's r, 0.93). Discussion: The Elecsys beta-amyloid (1-42) assay has high analytical performance that may improve biomarker-based AD diagnosis. (C) 2015 The Authors. Published by Elsevier Inc. on behalf of Alzheimer's Association.

引用

页码：517 / 526

页数：10

共 49 条

[31] Targeted proteomics in Alzheimer's disease:: focus on amyloid-β [J].