Journal article

Elecsys® Total-Tau and Phospho-Tau (181P) CSF assays: Analytical performance of the novel, fully automated immunoassays for quantification of tau proteins in human cerebrospinal fluid

V Lifke, G Kollmorgen, E Manuilova, T Oelschlaegel, L Hillringhaus, M Widmann, CAF von Arnim, M Otto, RH Christenson, JL Powers, LM Shaw, O Hansson, JD Doecke, QX Li, C Teunissen, H Tumani, K Blennow

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

Abstract

Background: Total tau (tTau) and phosphorylated 181P tau (pTau) are supportive diagnostic cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease. Manual CSF tau assays are limited by lot-to-lot and between-laboratory variability and long incubation/turnaround times. Elecsys® Total-Tau CSF and Phospho-Tau (181P) CSF immunoassays were developed for fully automated cobas e analyzers, allowing broader access in clinical practice and trials. Methods: Analytical performance, reproducibility, method comparisons with commercially available assays, and lot-to-lot and platform comparability (cobas e 601/411) of the Elecsys® CSF assays were assessed. Tau distributions and concentration ranges wer..

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University of Melbourne Researchers

Grants

Funding Acknowledgements

This work was supported 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.