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• W2135143132 abstract "The integration of immunoassays for cerebrospinal fluid (CSF) tau and β-amyloid (Aβ) into the routine clinical diagnostic work-up, as well as the acceptance by the regulatory authorities, is delayed by some analytical performance issues. There is upcoming evidence that more diagnostic relevant information will be obtained when (i) concentrations of different isoforms of above mentioned proteins are quantified, or (ii) when the nature of confounding factors that affect cut-off value determinations, are taken into account. Consequently, the AD field needs more biomarkers to normalize the secretion of the pathological isoform of the protein against the overall level of a specific family of proteins (e.g., tau, Aβ) (= protein profiling). The paper describes the development of a novel prototype immunoassays to quantify Aβ 1-38 in CSF and apolipoproteins E isoforms in CSF/plasma/serum. The analytical performance characteristics will be described, together with initial clinical performance data of the novel analytes in combination with tau and Aβ (Aβ 1-40, Aβ 1-42) proteins. Novel ELISAs were developed with specific monoclonal antibodies. The test procedures of the assays were harmonized with the other already available CSF biomarker assays (tau, Aβ 1-40, Aβ 1-42), especially with respect to test procedures and sample handling. The assays were developed for several sample types. The analytical characteristics (e.g., specificity, precision, accuracy, assay range, sample stability) of the assays will be described in detail. In contrast to the use of Aβ 1-40, it is possible to use identical volumes of CSF for Aβ 1-38 and Aβ 1-42, which will be an advantage for automation of the test procedures. Inclusion of apolipoprotein E and E4 immunoassays into the clinical work-up will help to stratify subject groups in function of their APOE genotype (no genotyping technology required). The clinical accuracy of Aβ 1-38, Aβ 1-40, Aβ 1-42, as well as corresponding ratios, will be compared using CSF from healthy control, AD, and non-AD subjects. Inclusion of Aβ 1-38 and apolipoprotein E(4) immunoassays in CSF biomarker panels will help the AD field to increase acceptance of clinical utility of CSF biomarker testing. Integration of biological factors that contribute to Aß 1-42 measurements could probably reduce the variability observed between studies and centers." @default.
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• W2135143132 date "2014-07-01" @default.
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• W2135143132 title "P2-112: QUANTIFICATION OF CSF Aβ1-38, TOGETHER WITH APOLIPOPROTEINS E, CAN IMPROVE THE CLINICAL DIAGNOSTIC ACCURACY FOR AD OF THE CSF TAU AND Aβ ASSAYS" @default.
• W2135143132 doi "https://doi.org/10.1016/j.jalz.2014.05.787" @default.
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