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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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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 Vanderstichele1 / Karen De Vreese2 / Kaj Blennow3 / Niels Andreasen4 / Christian Sindic5 / Adrian Ivanoiu6 / Harald Hampel7 / Katharina Bürger8 / Lucilla Parnetti9 / Alessia Lanari10 / Allesandro Padovani11 / Monica DiLuca12 / Miriam Bläser13 / Annika Ohrfelt Olsson14 / Hans Pottel15 / Frank Hulstaert16 / Eugeen Vanmechelen17


















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

Citation Information: Clinical Chemical Laboratory Medicine. Volume 44, Issue 12, Pages 1472–1480, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2006.258, December 2006

Publication History

May 13, 2006
September 14, 2006
Published Online:


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.

Keywords: Alzheimer's disease; cerebrospinal fluid; dementia; diagnosis; performance; P-tau181P

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