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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,

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

Keywords: cerebrospinal fluid, dementia, diagnosis, performance, P-tau181P

Background: Total tau (T-tau) and ?-amyloid_(1-42) (A?_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 A?_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.

Clin Chem Lab Med 2006;44:1472–80.

Clinical Chemical Laboratory Medicine, Walter de Gruyter

Print ISSN: 1434-6621
Volume: 44, 12/2006
Pages: 1472 - 1480

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