Boulo, S;
Kuhlmann, J;
Andreasson, U;
Brix, B;
Venkataraman, I;
Herbst, V;
Rutz, S;
... Blennow, K; + view all
(2020)
First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays.
Alzheimer's & Dementia
, 16
(11)
pp. 1493-1503.
10.1002/alz.12145.
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Abstract
INTRODUCTION: Reference materials based on human cerebrospinal fluid were certified for the mass concentration of amyloid beta (Aβ)1-42 (Aβ42 ). They are intended to be used to calibrate diagnostic assays for Aβ42 . METHODS: The three certified reference materials (CRMs), ERM-DA480/IFCC, ERM-DA481/IFCC and ERM-DA482/IFCC, were prepared at three concentration levels and characterized using isotope dilution mass spectrometry methods. Roche, EUROIMMUN, and Fujirebio used the three CRMs to re-calibrate their immunoassays. RESULTS: The certified Aβ42 mass concentrations in ERM-DA480/IFCC, ERM-DA481/IFCC, and ERM-DA482/IFCC are 0.45, 0.72, and 1.22 μg/L, respectively, with expanded uncertainties (k = 2) of 0.07, 0.11, and 0.18 μg/L, respectively. Before re-calibration, a good correlation (Pearson's r > 0.97), yet large biases, were observed between results from different commercial assays. After re-calibration the between-assay bias was reduced to < 5%. DISCUSSION: The Aβ42 CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ42 .
| Type: | Article |
|---|---|
| Title: | First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1002/alz.12145 |
| Publisher version: | https://doi.org/10.1002/alz.12145 |
| Language: | English |
| Additional information: | © 2020 European Commission - Joint Research Centre. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/). |
| Keywords: | Alzheimer's disease, amyloid beta peptide, certified reference material, commercial immunoassays |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Neurodegenerative Diseases |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10107454 |
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