Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of β‐amyloid (1–42) in human cerebrospinal fluid. Issue 5 (7th November 2015)

• Record Type: Journal Article
• Authors: Bittner, Tobias; Zetterberg, Henrik; Teunissen, Charlotte E.; Ostlund, Richard E.; Militello, Michael; Andreasson, Ulf; Hubeek, Isabelle; Gibson, David; Chu, David C.; Eichenlaub, Udo; Heiss, Peter; Kobold, Uwe; Leinenbach, Andreas; Madin, Kairat; Manuilova, Ekaterina; Rabe, Christina; Blennow, Kaj
• Is Part Of: Alzheimer's & dementia. Volume 12:Issue 5(2016)
• Page Start: 517
• Page End: 526
• Publication Date: 2015-11-07
• Subjects: Amyloid -- Amyloid‐beta 1–42 -- Alzheimer's disease -- Assay -- Biomarker -- Cerebrospinal fluid -- Dementia -- Diagnosis -- Electrochemiluminescence -- Immunoassay -- Method comparison -- Precision -- Repeatability -- Reproducibility -- Variability; Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1016/j.jalz.2015.09.009
• Languages: English
• ISSNs: 1552-5260

Abstract

Abstract: Introduction: Available assays for quantitation of the Alzheimer's disease (AD) biomarker amyloid‐beta 1–42 (Aβ [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 β‐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 β‐amyloid (1–42) assay has high analytical performance that may improve biomarker‐based AD diagnosis.