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

Research output: Contribution to journalArticle

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 were evaluated in CSF samples from two clinical cohorts. Results: Both assays showed high sensitivity (limit of quantitation [LoQ]: 63 pg/mL [tTau]; 4 pg/mL [pTau]) and linearity over the measuring range (80–1300 pg/mL; 8–120 pg/mL), which covered the entire concentration range measured in clinical samples. Lot-to-lot and platform comparability demonstrated good consistency (Pearson's r: 0.998; 1.000). Multicenter evaluation coefficients of variation (CVs): repeatability, < 1.8%; intermediate precision, < 2.8%; between-laboratory variability, < 2.7% (both assays); and total reproducibility, < 6.7% (tTau) and < 4.7% (pTau). Elecsys® CSF assays demonstrated good correlation with commercially available tau assays. Conclusions: Elecsys® Total-Tau CSF and Phospho-Tau (181P) CSF assays demonstrate good analytical performance with clinically relevant measuring ranges; data support their use in clinical trials and practice.

Details

Authors
  • Valeria Lifke
  • Gwendlyn Kollmorgen
  • Ekaterina Manuilova
  • Tobias Oelschlaegel
  • Lars Hillringhaus
  • Monika Widmann
  • Christine A.F. von Arnim
  • Markus Otto
  • Robert H. Christenson
  • Jennifer L. Powers
  • Leslie M. Shaw
  • Oskar Hansson
  • James D. Doecke
  • Qiao Xin Li
  • Charlotte Teunissen
  • Hayrettin Tumani
  • Kaj Blennow
Organisations
External organisations
  • Roche Diagnostics
  • University Hospital of Ulm
  • Washington University in St. Louis
  • University of Pennsylvania
  • Skåne University Hospital
  • University of Melbourne
  • Academic Medical Center
  • Sahlgrenska University Hospital
  • University of Gothenburg
  • Vrije Universiteit Amsterdam
  • University of Maryland
  • Australian e-Health Research Centre
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Medicinal Chemistry

Keywords

  • Alzheimer's disease, Biomarkers, CSF, Fully automated immunoassay, Phosphorylated tau, Total tau
Original languageEnglish
JournalClinical Biochemistry
Publication statusE-pub ahead of print - 2019 May 23
Publication categoryResearch
Peer-reviewedYes