Journal article

Method comparison study of the Elecsys (R) beta-Amyloid (1-42) CSF assay versus comparator assays and LC-MS/MS

Leslie M Shaw, Oskar Hansson, Ekaterina Manuilova, Colin L Masters, James D Doecke, Qiao-Xin Li, Sandra Rutz, Monika Widmann, Andreas Leinenbach, Kaj Blennow

Clinical Biochemistry | PERGAMON-ELSEVIER SCIENCE LTD | Published : 2019


BACKGROUND: Alzheimer's disease (AD) biomarkers, such as cerebrospinal fluid (CSF) amyloid-β (1-42; Aβ42), can provide high diagnostic accuracy. Several immunoassays are available for Aβ42 quantitation, but standardisation across assays remains an issue. We compared the Elecsys® β-Amyloid (1-42) CSF assay with three assays and two liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. METHODS: Three method comparison studies evaluated the correlation between the Elecsys® β-Amyloid (1-42) CSF assay versus: INNOTEST® β-AMYLOID(1-42) (860 samples) and the Roche Diagnostics-developed LC-MS/MS method (250 samples); INNO-BIA AlzBio3 and the University of Pennsylvania (UPenn)-developed ..

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Funding Acknowledgements

The presented analyses were sponsored by Roche Diagnostics. The sponsor was involved in study design, the collection and interpretation of the data and writing of the manuscript. All authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.Medical writing support, under the direction of the authors, was provided by David Evans, PhD and Louise Kelly, BSc (Gardiner Caldwell Communications, Macclesfield, UK) and was funded by Roche Diagnostics.