First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays
© 2020 European Commission - Joint Research Centre. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2020 |
|---|---|
| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
|---|---|
| Enthalten in: |
Alzheimer's & dementia : the journal of the Alzheimer's Association - 16(2020), 11 vom: 16. Nov., Seite 1493-1503 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Boulo, Sébastien [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Alzheimer's disease |
|---|
| Anmerkungen: |
Date Completed 27.09.2021 Date Revised 27.09.2021 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1002/alz.12145 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM313302375 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM313302375 | ||
| 003 | DE-627 | ||
| 005 | 20231225150301.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2020 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1002/alz.12145 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1044.xml |
| 035 | |a (DE-627)NLM313302375 | ||
| 035 | |a (NLM)32755010 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Boulo, Sébastien |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 27.09.2021 | ||
| 500 | |a Date Revised 27.09.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 European Commission - Joint Research Centre. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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% | ||
| 520 | |a DISCUSSION: The Aβ42 CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ42 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Alzheimer's disease | |
| 650 | 4 | |a amyloid beta peptide | |
| 650 | 4 | |a certified reference material | |
| 650 | 4 | |a commercial immunoassays | |
| 650 | 7 | |a Amyloid beta-Peptides |2 NLM | |
| 700 | 1 | |a Kuhlmann, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a Andreasson, Ulf |e verfasserin |4 aut | |
| 700 | 1 | |a Brix, Britta |e verfasserin |4 aut | |
| 700 | 1 | |a Venkataraman, Iswariya |e verfasserin |4 aut | |
| 700 | 1 | |a Herbst, Victor |e verfasserin |4 aut | |
| 700 | 1 | |a Rutz, Sandra |e verfasserin |4 aut | |
| 700 | 1 | |a Manuilova, Ekaterina |e verfasserin |4 aut | |
| 700 | 1 | |a Vandijck, Manu |e verfasserin |4 aut | |
| 700 | 1 | |a Dekeyser, Filip |e verfasserin |4 aut | |
| 700 | 1 | |a Bjerke, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Pannee, Josef |e verfasserin |4 aut | |
| 700 | 1 | |a Charoud-Got, Jean |e verfasserin |4 aut | |
| 700 | 1 | |a Auclair, Guy |e verfasserin |4 aut | |
| 700 | 1 | |a Mazoua, Stéphane |e verfasserin |4 aut | |
| 700 | 1 | |a Pinski, Gregor |e verfasserin |4 aut | |
| 700 | 1 | |a Trapmann, Stefanie |e verfasserin |4 aut | |
| 700 | 1 | |a Schimmel, Heinz |e verfasserin |4 aut | |
| 700 | 1 | |a Emons, Hendrik |e verfasserin |4 aut | |
| 700 | 1 | |a Quaglia, Milena |e verfasserin |4 aut | |
| 700 | 1 | |a Portelius, Erik |e verfasserin |4 aut | |
| 700 | 1 | |a Korecka, Magdalena |e verfasserin |4 aut | |
| 700 | 1 | |a Shaw, Leslie M |e verfasserin |4 aut | |
| 700 | 1 | |a Lame, Mary |e verfasserin |4 aut | |
| 700 | 1 | |a Chambers, Erin |e verfasserin |4 aut | |
| 700 | 1 | |a Vanderstichele, Hugo |e verfasserin |4 aut | |
| 700 | 1 | |a Stoops, Erik |e verfasserin |4 aut | |
| 700 | 1 | |a Leinenbach, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Bittner, Tobias |e verfasserin |4 aut | |
| 700 | 1 | |a Jenkins, Rand G |e verfasserin |4 aut | |
| 700 | 1 | |a Kostanjevecki, Vesna |e verfasserin |4 aut | |
| 700 | 1 | |a Lewczuk, Piotr |e verfasserin |4 aut | |
| 700 | 1 | |a Gobom, Johan |e verfasserin |4 aut | |
| 700 | 1 | |a Zetterberg, Henrik |e verfasserin |4 aut | |
| 700 | 1 | |a Zegers, Ingrid |e verfasserin |4 aut | |
| 700 | 1 | |a Blennow, Kaj |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Alzheimer's & dementia : the journal of the Alzheimer's Association |d 2005 |g 16(2020), 11 vom: 16. Nov., Seite 1493-1503 |w (DE-627)NLM168942356 |x 1552-5279 |7 nnns |
| 773 | 1 | 8 | |g volume:16 |g year:2020 |g number:11 |g day:16 |g month:11 |g pages:1493-1503 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1002/alz.12145 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 16 |j 2020 |e 11 |b 16 |c 11 |h 1493-1503 | ||