CSF Aβ1-42- an excellent but complicated Alzheimer's biomarker - a route to standardisation

Kuhlmann J, Andreasson U, Pannee J, Bjerke M, Portelius E, Leinenbach A, Bittner T, Korecka M, Jenkins RG, Vanderstichele H, Stoops E, Lewczuk P, Shaw LM, Zegers I, Schimmel H, Zetterberg H, Blennow K (2017)

Publication Type: Journal article

Publication year: 2017

Journal

Clinica Chimica Acta Elsevier

Book Volume: 467

Pages Range: 27-33

DOI: 10.1016/j.cca.2016.05.014

Abstract

The 42 amino acid form of amyloid β (Aβ1-42) in cerebrospinal fluid (CSF) has been widely accepted as a central biomarker for Alzheimer's disease. Several immunoassays for CSF Aβ1-42are commercially available, but can suffer from between laboratory and batch-to-batch variability as well as lack of standardisation across assays. As a consequence, no general cut-off values have been established for a specific context of use (e.g., clinical diagnostics) and selection of individuals for enrolment in clinical trials (patient stratification) remains challenging. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has initiated a working group for CSF proteins (WG-CSF) to facilitate standardisation of CSF Aβ1-42measurement results. The efforts of the IFCC WG-CSF include the development of certified reference materials (CRMs) and reference measurement procedures (RMPs) for key biomarkers. Two candidate RMPs for quantification of Aβ1-42in CSF based on liquid chromatography tandem mass spectrometry have been developed and tested in two ring trials. Furthermore, two commutability studies including native CSF pools, artificial CSF and spiked materials have been completed. On the basis of these studies, human CSF pools containing only endogenous Aβ1-42at three concentrations were selected as the format for future CRMs that are now being processed.

Authors with CRIS profile

Piotr Lewczuk Department of Psychiatry and Psychotherapy

Involved external institutions

European Commission - Joint Research Centre (JRC) NL Netherlands (NL) University of Gothenburg / Göteborgs universitet SE Sweden (SE) Roche Diagnostics GmbH DE Germany (DE) University of Pennsylvania US United States (USA) (US) PPD Labs US United States (USA) (US) ADx NeuroSciences BE Belgium (BE)

How to cite

APA:

Kuhlmann, J., Andreasson, U., Pannee, J., Bjerke, M., Portelius, E., Leinenbach, A.,... Blennow, K. (2017). CSF Aβ1-42- an excellent but complicated Alzheimer's biomarker - a route to standardisation. Clinica Chimica Acta, 467, 27-33. https://dx.doi.org/10.1016/j.cca.2016.05.014

MLA:

Kuhlmann, Julia, et al. "CSF Aβ1-42- an excellent but complicated Alzheimer's biomarker - a route to standardisation." Clinica Chimica Acta 467 (2017): 27-33.

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