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P1–167: Reproducibility of a fully automated, chemiluminescent, beta‐amyloid 42 assay
Author(s) -
Jackson Shari,
Green George,
Soares Holly,
Berisha Flora,
Neely Robert,
Baburina Irina,
Kozo Daniel,
Salamone Salvatore,
Tweedie Anne,
Ackles Karen,
Byrne Deb,
DiMagno Lisa
Publication year - 2013
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.2013.05.390
Subject(s) - chemiluminescence , reproducibility , mathematics , cerebrospinal fluid , chromatography , statistics , medicine , chemistry
upon a detailed unified SOP for the INNO-BIA AlzBio3 (RUO; Innogenetics nv, Belgium) multiplexing xMAP assay. Using the same assay batch, a set of ten CSF pool samples and two buffer based control samples were analyzed using ready-to-use calibrators. A fresh aliquot of each sample was tested in quadruplicate in three independent assay runs (only 2 runs for center C). The goal of the study was to determine the with-in and interlaboratory variability of the assay for hTau, Ab 1-42, and P-Tau 181P after implementation of the unified SOP. Results: The CSF analyte concentrations showed a strong correlation between all centers (R> 0.95; regression center versus overall center mean). For the CSF samples, the total inter-center variability over the 8 runs performed (%CV) ranged between 12.4 22.9% (hTau), 8.1 13.1% (Ab 1-42), and 6.8 13.2% (P-Tau 181P). Across the 10 CSF samples, the mean within-laboratory variation ranged between 1.8% and 11% for all analytes. The variability observed for the control samples was even lower (max. 4.5%).Conclusions: Implementation of a unified SOP in the three laboratories resulted in an acceptable inter-laboratory variation of analyte concentrations for CSF and control samples. Careful documentation of the critical parameters of the test procedure and rigorous adherence to a detailed instruction of use clearly leads to highly comparable CSF analyte concentrations between experienced centers.