1. First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays.
- Author
-
Boulo S, Kuhlmann J, Andreasson U, Brix B, Venkataraman I, Herbst V, Rutz S, Manuilova E, Vandijck M, Dekeyser F, Bjerke M, Pannee J, Charoud-Got J, Auclair G, Mazoua S, Pinski G, Trapmann S, Schimmel H, Emons H, Quaglia M, Portelius E, Korecka M, Shaw LM, Lame M, Chambers E, Vanderstichele H, Stoops E, Leinenbach A, Bittner T, Jenkins RG, Kostanjevecki V, Lewczuk P, Gobom J, Zetterberg H, Zegers I, and Blennow K more...
- Subjects
- Calibration, Humans, Immunoassay methods, Reference Standards, Amyloid beta-Peptides cerebrospinal fluid, Immunoassay standards
- Abstract
Introduction: Reference materials based on human cerebrospinal fluid were certified for the mass concentration of amyloid beta (Aβ)1-42 (Aβ
42 ). 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 ., (© 2020 European Commission - Joint Research Centre. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.) more...- Published
- 2020
- Full Text
- View/download PDF