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

Sébastien Boulo; Julia Kuhlmann; Ulf Andreasson; Britta Brix; Iswariya Venkataraman; Victor Herbst; Sandra Rutz; Ekaterina Manuilova; Manu Vandijck; Filip Dekeyser; Maria Bjerke; Josef Pannee; Jean Charoud-Got; Guy Auclair; Stéphane Mazoua; Gregor Pinski; Stefanie Trapmann; Heinz Schimmel; Hendrik Emons; Milena Quaglia; Erik Portelius; Magdalena Korecka; Leslie M Shaw; Mary Lame; Erin Chambers; Hugo Vanderstichele; Erik Stoops; Andreas Leinenbach; Tobias Bittner; Rand G Jenkins; Vesna Kostanjevecki; Piotr Lewczuk; Johan Gobom; Henrik Zetterberg; Ingrid Zegers; Kaj Blennow

doi:10.1002/alz.12145

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

Sébastien Boulo, Julia Kuhlmann, Ulf Andreasson, Britta Brix, Iswariya Venkataraman, Victor Herbst, Sandra Rutz, Ekaterina Manuilova, Manu Vandijck, Filip Dekeyser, Maria Bjerke, Josef Pannee, Jean Charoud-Got, Guy Auclair, Stéphane Mazoua, Gregor Pinski, Stefanie Trapmann, Heinz Schimmel, Hendrik Emons, Milena QuagliaErik Portelius, Magdalena Korecka, Leslie M Shaw, Mary Lame, Erin Chambers, Hugo Vanderstichele, Erik Stoops, Andreas Leinenbach, Tobias Bittner, Rand G Jenkins, Vesna Kostanjevecki, Piotr Lewczuk, Johan Gobom, Henrik Zetterberg, Ingrid Zegers, Kaj Blennow

Research output: Contribution to journal › Article › peer-review

47 Citations (Scopus)

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 Aβ ₄₂. 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 Aβ ₄₂ 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 Aβ ₄₂ CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ ₄₂.

Original language	English
Pages (from-to)	1493-1503
Number of pages	11
Journal	Alzheimer's & Dementia
Volume	16
Issue number	11
Early online date	4 Aug 2020
DOIs	https://doi.org/10.1002/alz.12145
Publication status	Published - Nov 2020

Bibliographical note

Keywords

Alzheimer's disease
amyloid beta peptide
certified reference material
commercial immunoassays

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10.1002/alz.12145

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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., ... Blennow, K. (2020). First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays. Alzheimer's & Dementia, 16(11), 1493-1503. https://doi.org/10.1002/alz.12145

Boulo, Sébastien ; Kuhlmann, Julia ; Andreasson, Ulf ; Brix, Britta ; Venkataraman, Iswariya ; Herbst, Victor ; Rutz, Sandra ; Manuilova, Ekaterina ; Vandijck, Manu ; Dekeyser, Filip ; Bjerke, Maria ; Pannee, Josef ; Charoud-Got, Jean ; Auclair, Guy ; Mazoua, Stéphane ; Pinski, Gregor ; Trapmann, Stefanie ; Schimmel, Heinz ; Emons, Hendrik ; Quaglia, Milena ; Portelius, Erik ; Korecka, Magdalena ; Shaw, Leslie M ; Lame, Mary ; Chambers, Erin ; Vanderstichele, Hugo ; Stoops, Erik ; Leinenbach, Andreas ; Bittner, Tobias ; Jenkins, Rand G ; Kostanjevecki, Vesna ; Lewczuk, Piotr ; Gobom, Johan ; Zetterberg, Henrik ; Zegers, Ingrid ; Blennow, Kaj. / First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays. In: Alzheimer's & Dementia. 2020 ; Vol. 16, No. 11. pp. 1493-1503.

@article{ed17ae5bfb674754b17f7fe5d1352bc5,

title = "First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays",

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 Aβ 42. 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 Aβ 42 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 Aβ 42 CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ 42. ",

keywords = "Alzheimer's disease, amyloid beta peptide, certified reference material, commercial immunoassays",

author = "S{\'e}bastien Boulo and Julia Kuhlmann and Ulf Andreasson and Britta Brix and Iswariya Venkataraman and Victor Herbst and Sandra Rutz and Ekaterina Manuilova and Manu Vandijck and Filip Dekeyser and Maria Bjerke and Josef Pannee and Jean Charoud-Got and Guy Auclair and St{\'e}phane Mazoua and Gregor Pinski and Stefanie Trapmann and Heinz Schimmel and Hendrik Emons and Milena Quaglia and Erik Portelius and Magdalena Korecka and Shaw, {Leslie M} and Mary Lame and Erin Chambers and Hugo Vanderstichele and Erik Stoops and Andreas Leinenbach and Tobias Bittner and Jenkins, {Rand G} and Vesna Kostanjevecki and Piotr Lewczuk and Johan Gobom and Henrik Zetterberg and Ingrid Zegers and Kaj Blennow",

note = "{\textcopyright} 2020 European Commission - Joint Research Centre. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.",

year = "2020",

month = nov,

doi = "10.1002/alz.12145",

language = "English",

volume = "16",

pages = "1493--1503",

journal = "Alzheimer's & Dementia",

issn = "1552-5260",

publisher = "Elsevier",

number = "11",

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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, 'First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays', Alzheimer's & Dementia, vol. 16, no. 11, pp. 1493-1503. https://doi.org/10.1002/alz.12145

First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays. / Boulo, Sébastien; Kuhlmann, Julia; Andreasson, Ulf; Brix, Britta; Venkataraman, Iswariya; Herbst, Victor; Rutz, Sandra; Manuilova, Ekaterina; Vandijck, Manu; Dekeyser, Filip; Bjerke, Maria; Pannee, Josef; Charoud-Got, Jean; Auclair, Guy; Mazoua, Stéphane; Pinski, Gregor; Trapmann, Stefanie; Schimmel, Heinz; Emons, Hendrik; Quaglia, Milena; Portelius, Erik; Korecka, Magdalena; Shaw, Leslie M; Lame, Mary; Chambers, Erin; Vanderstichele, Hugo; Stoops, Erik; Leinenbach, Andreas; Bittner, Tobias; Jenkins, Rand G; Kostanjevecki, Vesna; Lewczuk, Piotr; Gobom, Johan; Zetterberg, Henrik; Zegers, Ingrid; Blennow, Kaj.

In: Alzheimer's & Dementia, Vol. 16, No. 11, 11.2020, p. 1493-1503.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays

AU - Boulo, Sébastien

AU - Kuhlmann, Julia

AU - Andreasson, Ulf

AU - Brix, Britta

AU - Venkataraman, Iswariya

AU - Herbst, Victor

AU - Rutz, Sandra

AU - Manuilova, Ekaterina

AU - Vandijck, Manu

AU - Dekeyser, Filip

AU - Bjerke, Maria

AU - Pannee, Josef

AU - Charoud-Got, Jean

AU - Auclair, Guy

AU - Mazoua, Stéphane

AU - Pinski, Gregor

AU - Trapmann, Stefanie

AU - Schimmel, Heinz

AU - Emons, Hendrik

AU - Quaglia, Milena

AU - Portelius, Erik

AU - Korecka, Magdalena

AU - Shaw, Leslie M

AU - Lame, Mary

AU - Chambers, Erin

AU - Vanderstichele, Hugo

AU - Stoops, Erik

AU - Leinenbach, Andreas

AU - Bittner, Tobias

AU - Jenkins, Rand G

AU - Kostanjevecki, Vesna

AU - Lewczuk, Piotr

AU - Gobom, Johan

AU - Zetterberg, Henrik

AU - Zegers, Ingrid

AU - Blennow, Kaj

PY - 2020/11

Y1 - 2020/11

N2 - 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 Aβ 42. 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 Aβ 42 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 Aβ 42 CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ 42.

AB - 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 Aβ 42. 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 Aβ 42 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 Aβ 42 CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ 42.

KW - Alzheimer's disease

KW - amyloid beta peptide

KW - certified reference material

KW - commercial immunoassays

UR - http://www.scopus.com/inward/record.url?scp=85088978593&partnerID=8YFLogxK

U2 - 10.1002/alz.12145

DO - 10.1002/alz.12145

M3 - Article

C2 - 32755010

VL - 16

SP - 1493

EP - 1503

JO - Alzheimer's & Dementia

JF - Alzheimer's & Dementia

SN - 1552-5260

IS - 11

ER -

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

Abstract

Bibliographical note

Keywords

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