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Analytical performance and clinical utility of the INNOTEST® PHOSPHO-TAU(181P) assay for discrimination between Alzheimer's disease and dementia with Lewy bodies

  • Hugo Vanderstichele , Karen De Vreese , Kaj Blennow , Niels Andreasen , Christian Sindic , Adrian Ivanoiu , Harald Hampel , Katharina Bürger , Lucilla Parnetti , Alessia Lanari , Allesandro Padovani , Monica DiLuca , Miriam Bläser , Annika Ohrfelt Olsson , Hans Pottel , Frank Hulstaert and Eugeen Vanmechelen
Published/Copyright: December 13, 2006

Abstract

Background: Total tau (T-tau) and β-amyloid(1-42) (Aβ1-42) levels in cerebrospinal fluid (CSF) can differentiate Alzheimer's disease (AD) from normal aging or depressive pseudo-dementia. Differential diagnosis from dementia with Lewy bodies (DLB) in clinical settings is difficult.

Methods: The analytical performance of the INNOTEST® PHOSPHO-TAU(181P) assay was validated in terms of selectivity, sensitivity, specificity, precision, robustness, and stability. Clinical utility of the assay alone, or combined with T-tau and Aβ1-42, for discrimination of AD (n=94) from patients suffering from DLB (n=60) or from age-matched control subjects (CS) (n=60) was assessed in a multicenter study.

Results: CSF concentrations of tau phosphorylated at threonine 181 (P-tau181P) in AD was significantly higher than in DLB and CS. Discriminant analysis, a classification tree, and logistic regression showed that P-tau181P was the most statistically significant single variable of the three biomarkers for discrimination between AD and DLB.

Conclusions: P-tau181P quantification is a robust and reliable assay that may be useful in discriminating AD from DLB.

Clin Chem Lab Med 2006;44:1472–80.


Corresponding author: Hugo Vanderstichele, PhD, Innogenetics, Industriepark Zwijnaarde 7, P.O. Box 4, 9052 Gent, Belgium Phone: +32-9-2410711, Fax: +32-9-2410907

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Received: 2006-5-13
Accepted: 2006-9-14
Published Online: 2006-12-13
Published in Print: 2006-12-1

©2006 by Walter de Gruyter Berlin New York

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