Analytical performance and clinical utility of the INNOTEST PHOSPHO-TAU181P assay for discrimination between Alzheimer's disease and dementia with Lewy bodies.
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.
Vanderstichele
Hugo
H
Innogenetics NV, Industriepark Zwijnaarde 7, 9052 Gent, Belgium. hugovdr@innogenetics.be
De Vreese
Karen
K
Blennow
Kaj
K
Andreasen
Niels
N
Sindic
Christian
C
Ivanoiu
Adrian
A
Hampel
Harald
H
Bürger
Katharina
K
Parnetti
Lucilla
L
Lanari
Alessia
A
Padovani
Allesandro
A
DiLuca
Monica
M
Bläser
Miriam
M
Olsson
Annika Ohrfelt
AO
Pottel
Hans
H
Hulstaert
Frank
F
Vanmechelen
Eugeen
E
D000368:Aged; D000544:Alzheimer Disease / Q000175:diagnosis*; D016229:Amyloid beta-Peptides / Q000134:cerebrospinal fluid; D015415:Biomarkers / Q000134:cerebrospinal fluid; D003937:Diagnosis, Differential; D016002:Discriminant Analysis; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D006801:Humans; D020961:Lewy Body Disease / Q000175:diagnosis*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000134:cerebrospinal fluid; D010769:Phosphothreonine / Q000378:metabolism; D012372:ROC Curve; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016875:tau Proteins / Q000134:cerebrospinal fluid* / Q000378:metabolism
D016229:Amyloid beta-Peptides; D015415:Biomarkers; C054369:MAPT protein, human; D010446:Peptide Fragments; D011933:Reagent Kits, Diagnostic; C075222:amyloid beta-protein (1-42); D016875:tau Proteins; D010769:Phosphothreonine