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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

Lifke, Valeria; Kollmorgen, Gwendlyn; Manuilova, Ekaterina; Oelschlaegel, Tobias; Hillringhaus, Lars; Widmann, Monika; von Arnim, Christine A.F.; Otto, Markus; Christenson, Robert H. and Powers, Jennifer L., et al. (2019) In Clinical Biochemistry
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... (More)

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.

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@article{143c7feb-973d-4dc9-ad75-662ce8345dec,
  abstract     = {<p>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<sup>®</sup> 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<sup>®</sup> 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, &lt; 1.8%; intermediate precision, &lt; 2.8%; between-laboratory variability, &lt; 2.7% (both assays); and total reproducibility, &lt; 6.7% (tTau) and &lt; 4.7% (pTau). Elecsys<sup>®</sup> CSF assays demonstrated good correlation with commercially available tau assays. Conclusions: Elecsys<sup>®</sup> 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.</p>},
  author       = {Lifke, Valeria and Kollmorgen, Gwendlyn and Manuilova, Ekaterina and Oelschlaegel, Tobias and Hillringhaus, Lars and Widmann, Monika and von Arnim, Christine A.F. and Otto, Markus and Christenson, Robert H. and Powers, Jennifer L. and Shaw, Leslie M. and Hansson, Oskar and Doecke, James D. and Li, Qiao Xin and Teunissen, Charlotte and Tumani, Hayrettin and Blennow, Kaj},
  issn         = {0009-9120},
  keyword      = {Alzheimer's disease,Biomarkers,CSF,Fully automated immunoassay,Phosphorylated tau,Total tau},
  language     = {eng},
  month        = {05},
  publisher    = {Elsevier},
  series       = {Clinical Biochemistry},
  title        = {Elecsys<sup>®</sup> 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},
  url          = {http://dx.doi.org/10.1016/j.clinbiochem.2019.05.005},
  year         = {2019},
}