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Analytical performance and clinical utility of the INNOTEST PHOSPHO-TAU181P assay for discrimination between Alzheimer's disease and dementia with Lewy bodies.

Journal article
Authors 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 Öhrfelt Olsson
Hans Pottel
Frank Hulstaert
Eugeen Vanmechelen
Published in Clinical chemistry and laboratory medicine : CCLM / FESCC
Volume 44
Issue 12
Pages 1472-80
ISSN 1434-6621
Publication year 2006
Published at Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
Pages 1472-80
Language en
Keywords Aged, Alzheimer Disease, diagnosis, Amyloid beta-Protein, cerebrospinal fluid, Biological Markers, cerebrospinal fluid, Diagnosis, Differential, Discriminant Analysis, Enzyme-Linked Immunosorbent Assay, methods, Female, Humans, Lewy Body Disease, diagnosis, Logistic Models, Male, Middle Aged, Peptide Fragments, cerebrospinal fluid, Phosphothreonine, metabolism, ROC Curve, Reagent Kits, Diagnostic, standards, Reproducibility of Results, Sensitivity and Specificity, tau Proteins, cerebrospinal fluid, metabolism
Subject categories Neurochemistry


BACKGROUND: Total tau (T-tau) and beta-amyloid((1-42)) (Abeta(1-42)) 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 Abeta(1-42), 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-tau(181P)) in AD was significantly higher than in DLB and CS. Discriminant analysis, a classification tree, and logistic regression showed that P-tau(181P) was the most statistically significant single variable of the three biomarkers for discrimination between AD and DLB. CONCLUSIONS: P-tau(181P) quantification is a robust and reliable assay that may be useful in discriminating AD from DLB.

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