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P1‐158: IMPROVEMENTS TO INNOTEST® HTAU AG
Author(s) -
Leen Jef Vandijck Manu,
Decraemer Hilde,
De Decker Bart,
Darby Heather,
Huyck Els,
Kostanjevecki Vesna
Publication year - 2014
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2014.05.396
Subject(s) - diluent , chromatography , chemistry , replicate , analyte , analytical chemistry (journal) , detection limit , mathematics , statistics , nuclear chemistry
properties of these proteins and the interference of matrix components make the establishment of referencematerials very challenging. As a consequence up to now, the trust in the in commercial assays is limited. Since CSF quality control samples were not broadly available. Methods: A large number of individual CSF samples were pooled to establish 5 samples with different A b 1-42 and Ab 1-40 concentrations. Different compounds were added to the pools before lyophilization. The pools underwent one freeze-thaw cycle before aliquotation (250 ml, polypropylene screw-cap tubes). All aliquots were lyophilized and stored at -20 C. The consistency and homogeneity of the prepared panel was evaluated using three different lot numbers of the assays and analysis in 3 different laboratories by different users. In addition, the performance of the proficiency panel was integrated into a multicenter study and compared to performances of neat CSF or run-validation samples (1⁄4 analyte in buffer). Results: Addition of components do not affect analytical behavior of the CSF sample. Lyophilisation of the samples was successful. Stability was considerably increased by that procedure as analytes showed only 5% CV after one week at 37 C. Neat CSF, with and without the additives, as well as samples from the proficiency panel, showed a very good parallelism (1⁄4 absence of matrix interference in the assays) upon dilution for the three analytes evaluated in the study. The production process did not change the intrinsic characteristics of the CSF samples. Overall variability in a multicenter study for the proficiency panel did not exceed > 10%, including the sum of % CVof intra-run, inter-run, inter-operator, and inter-lab. Conclusions: A panel of 5 stabilized and lyophilized CSF samples with target values covering the whole range of the calibration curve of the A b 1-42 , Ab 1-40 and Total-Tau ELISA. The excellent precision data obtained in a multicenter study make this panel an excellent new tool to verify the quality of the biomarker measurements in research settings, but also for routine labs. In the absence of an international reference standard, this commercially available proficiency panel may significantly increase the trust in the values measured by ELISA of CSF diagnostics.

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