Analytical performance and clinical utility of the INNOTEST (R) PHOSPHO-TAU((181P)) assay for discrimination between Alzheimer's disease and dementia with Lewy bodies
Vanderstichele, Hugo × De Vreese, Karen Blennow, Kaj Andreasen, Niels Sindic, Christian Ivanoiu, Adrian Hampel, Harald Bürger, Katharina Parnetti, Lucilla Lanari, Alessia Padovani, Allesandro DiLuca, Monica Bläser, Miriam Olsson, Annika Ohrfelt Pottel, Hans Hulstaert, Frank Vanmechelen, Eugeen #
Clinical chemistry and laboratory medicine : CCLM / FESCC vol:44 issue:12 pages:1472-1480
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.