Title: Assessing the commutability of reference material formats for the harmonization of amyloid beta measurements
Authors: BJERKE MariaANDREASSON UlfKUHLMANN JULIAPORTELIUS ErikPANNEE JosefLEWCZUK PiotrUMEK RobertVANMECHELEN EugeenVANDERSTICHELE HugoSTOOPS ErikLEWIS JenniferVANDIJCK ManuKOSTANJEVECKI VesnaJERONIM AndreasSALAMONE SalvatoreSCHMIDT OliverMATZEN AnjaMADIN KairatEICHENLAUB UdoBITTNER TobiasSHAW LeslieZEGERS IngridZETTERBERG HenrikBLENNOW Kaj
Citation: CLINICAL CHEMISTRY AND LABORATORY MEDICINE vol. 54 no. 7 p. 1177–1191
Publisher: WALTER DE GRUYTER GMBH
Publication Year: 2016
JRC N°: JRC97107
ISSN: 1434-6621
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC97107
DOI: 10.1515/cclm-2015-0733
Type: Articles in periodicals and books
Abstract: Background The cerebrospinal fluid (CSF) amyloid-β (Aβ42) peptide is an important biomarker for Alzheimer’s disease (AD). Variability in measured Aβ42 concentrations at different laboratories may be overcome by standardization and establishing traceability to a reference system. Candidate certified reference materials (CRMs) are validated herein for this purpose. Methods Commutability of 16 candidate CRM formats was assessed across five CSF Aβ42 immunoassays and one mass spectrometry (MS) method in a set of 48 individual clinical CSF samples. Promising candidate CRM formats (neat CSF and CSF spiked with Aβ42) were identified and subjected to validation across eight (Elecsys, EUROIMMUN, IBL, INNO-BIA AlzBio3, INNOTEST, MSD, Simoa, and Saladax) immunoassays and the MS method in 32 individual CSF samples. Commutability was evaluated by Passing-Bablok regression and the candidate CRM termed commutable when found within the prediction interval (PI). The relative distance to the regression line wa assessed. Results The neat CSF candidate CRM format was commutable for almost all method comparisons, except for the Simoa/MSD, Simoa/MS and MS/IBL where it was found just outside the 95% PI. However, the neat CSF was found within 5% relative distance to the regression line for MS/IBL, between 5-10% for Simoa/MS and between 10-15% for Simoa/MSD comparisons. Conclusions The neat CSF candidate CRM format was commutable for 33 of 36 method comparisons, onlyone comparison more than expected given the 95% PI acceptance limit. We conclude that the neat CSF candidate CRM can be used for value assignment of the kit calibrators for the different Aβ42 methods.
JRC Directorate:Health, Consumers and Reference Materials

Files in This Item:
There are no files associated with this item.


Items in repository are protected by copyright, with all rights reserved, unless otherwise indicated.