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• W2766310764 abstract "With an increasing number of demented people worldwide, measurement of biomarkers in cerebrospinal fluid (CSF) will be increasingly used as a routine diagnostic tool for diagnosis of Alzheimer's disease (AD). The integration of a novel phospho-tau(181P) ELISAs in routine lab environments requires assays with good analytical performance, robustness, user-friendliness and possibilities of automation. There is a need for different P-Tau assays to extend the clinical utility for this biomarker in the near future. A one-day P-Tau181 ELISA protocol was developed (including ready-to-use components) and qualified for manual and automated testing on any open ELISA platform, the Euroimmun Analyzer I. Protocols were optimized to allow parallel analysis of a completed biomarker profile ((Amyloid Beta 1–42 (Aß1–42), Aß1–40, (phospho)tau, synapse proteins). Analytical performance evaluation included intra-assay, inter-assay, working ranges, and interference studies. Clinically characterized samples from the University of Magdeburg were used to for comparison with a reference test, the INNOTEST Phospho-Tau(181P). The assay design of the Euroimmun P-Tau181 was compatible with the automated open ELISA platform. The automated protocol showed a linear regression of Analyzer I = 0,95x Manual incubation -0,5 pg/ml with a regression coefficient of R2=0,99. Analytical performance: Intra-Assay CV = 1,3%-5,0% (at 19–127pg/ml), Inter-Assay CV = 3,1% − 4,9% (at 26–119pg/ml) and showed no whole blood interference (up to 1% v/v) and no hook effect (up to 100ng/ml) was observed. Compared to Innotest the EUROIMMUN P-Tau181 showed increased sensitivity and specificity in n=107 clinically characterized samples (52 AD patients, 55 disease/healthy controls) with a sensitivity of 93,2% and specificity of 85,4% while Fuji showed a sensitivity of 66,1% and specificity of 91,7% (both using the same Cut-Off of 61pg/ml; ROC AUC Euroimmun = 0.94, AUC Fuji = 0.92). The Euroimmun P-Tau181 ELISA can be easily run on an open ELISA platform, using the same protocol and in parallel to assays for Aß(1–40), Aß(1–42), and total tau. The assay was qualified at the analytical and clinical level. The novel assay shows strong correlation in protein concentrations with a reference method, while its clinical performance was confirmed." @default.
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• W2766310764 date "2017-07-01" @default.
• W2766310764 modified "2023-09-27" @default.
• W2766310764 title "[P1-271]: A NOVEL COLORIMETRIC ELISA FOR QUANTIFICATION OF TAU, PHOSPHORYLATED AT THREONINE 181, IN CEREBROSPINAL FLUID" @default.
• W2766310764 doi "https://doi.org/10.1016/j.jalz.2017.06.287" @default.
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