First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays

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, Blennow K (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Alzheimers & Dementia Elsevier Masson

DOI: 10.1002/alz.12145

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.

Authors with CRIS profile

Piotr Lewczuk Department of Psychiatry and Psychotherapy

Involved external institutions

European Commission - Joint Research Centre (JRC) NL Netherlands (NL) Sahlgrenska University Hospital / Sahlgrenska Universitetssjukhuset SE Sweden (SE) EUROIMMUN Medizinische Labordiagnostika AG DE Germany (DE) EUROIMMUN US Inc. US United States (USA) (US) Roche Diagnostics GmbH DE Germany (DE) Fujirebio, Inc. / 富士レビオ株式会社 JP Japan (JP) LGC Group Ltd. / Laboratory of the Government Chemist GB United Kingdom (GB) Perelman School of Medicine University of Pennsylvania US United States (USA) (US) Waters Corporation US United States (USA) (US) ADx NeuroSciences BE Belgium (BE) F. Hoffmann-La Roche Ltd CH Switzerland (CH) PPD Inc. / Pharmaceutical Product Development US United States (USA) (US)

How to cite

APA:

Boulo, S., Kuhlmann, J., Andreasson, U., Brix, B., Venkataraman, I., Herbst, V.,... Blennow, K. (2020). First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays. Alzheimers & Dementia. https://doi.org/10.1002/alz.12145

MLA:

Boulo, Sébastien, et al. "First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays." Alzheimers & Dementia (2020).

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