Assessing the commutability of reference material formats for the harmonization of amyloid-? measurements

Bjerke M, Andreasson U, Kuhlmann J, Portelius E, Pannee J, Lewczuk P, Umek RM, Vanmechelen E, Vanderstichele H, Stoops E, Lewis J, Vandijck M, Kostanjevecki V, Jeromin A, Salamone SJ, Schmidt O, Matzen A, Madin K, Eichenlaub U, Bittner T, Shaw LM, Zegers I, Zetterberg H, Blennow K (2016)

Publication Type: Journal article

Publication year: 2016

Journal

Clinical Chemistry and Laboratory Medicine Walter de Gruyter

Book Volume: 54

Pages Range: 1177-91

Journal Issue: 7

DOI: 10.1515/cclm-2015-0733

Abstract

The cerebrospinal fluid (CSF) amyloid-? (A?42) peptide is an important biomarker for Alzheimer's disease (AD). Variability in measured A?42 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.Commutability of 16 candidate CRM formats was assessed across five CSF A?42 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 A?42) 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 was assessed.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% and 10% for Simoa/MS and between 10% and 15% for Simoa/MSD comparisons.The neat CSF candidate CRM format was commutable for 33 of 36 method comparisons, only one 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 A?42 methods.

Authors with CRIS profile

Piotr Lewczuk Department of Psychiatry and Psychotherapy

Involved external institutions

Quanterix Corporation US United States (USA) (US) University of Gothenburg / Göteborgs universitet SE Sweden (SE) European Commission - Joint Research Centre (JRC) NL Netherlands (NL) University of Pennsylvania US United States (USA) (US) Roche Diagnostics GmbH DE Germany (DE) IBL International GmbH DE Germany (DE) Saladax Biomedical Inc US United States (USA) (US) Fujirebio Europe NV BE Belgium (BE) Meso Scale Diagnostics US United States (USA) (US) ADx NeuroSciences BE Belgium (BE)

How to cite

APA:

Bjerke, M., Andreasson, U., Kuhlmann, J., Portelius, E., Pannee, J., Lewczuk, P.,... Blennow, K. (2016). Assessing the commutability of reference material formats for the harmonization of amyloid-? measurements. Clinical Chemistry and Laboratory Medicine, 54(7), 1177-91. https://doi.org/10.1515/cclm-2015-0733

MLA:

Bjerke, Maria, et al. "Assessing the commutability of reference material formats for the harmonization of amyloid-? measurements." Clinical Chemistry and Laboratory Medicine 54.7 (2016): 1177-91.

BibTeX: Download