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Commutability of the certified reference materials for the standardization of beta-amyloid 1-42 assay in human cerebrospinal fluid: lessons for tau and beta-amyloid 1-40 measurements

Artikel i vetenskaplig tidskrift
Författare Ulf Andreasson
J. Kuhlmann
Josef Pannee
R. M. Umek
E. Stoops
H. Vanderstichele
A. Matzen
M. Vandijck
M. Dauwe
A. Leinenbach
S. Rutz
Erik Portelius
I. Zegers
Henrik Zetterberg
Kaj Blennow
Publicerad i Clinical Chemistry and Laboratory Medicine
Volym 56
Nummer/häfte 12
Sidor 2058-2066
ISSN 1434-6621
Publiceringsår 2018
Publicerad vid Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi
Sidor 2058-2066
Språk en
Länkar dx.doi.org/10.1515/cclm-2018-0147
Ämnesord Alzheimer's disease, biomarkers, commutability, quality-control program, alzheimers-disease, blood biomarkers, csf, diagnosis, dementia, ratio, a-beta-42/a-beta-40, recommendations, validation, Medical Laboratory Technology
Ämneskategorier Neurokemi

Sammanfattning

Background: The core Alzheimer's disease cerebrospinal fluid (CSF) biomarkers total tau (T-tau), phosphorylated tau (P-tau), beta-amyloid 1-42 (A beta 42) and beta-amyloid 1-40 (A beta 40) are increasing in importance and are now part of the research criteria for the diagnosis of the disease. The main aim of this study is to evaluate whether a set of certified reference materials (CRMs) are commutable for A beta 42 and to serve as a feasibility study for the other markers. This property is a prerequisite for the establishment of CRMs which will then be used by manufacturers to calibrate their assays against. Once the preanalytical factors have been standardized and proper selection criteria are available for subject cohorts this harmonization between methods will allow for universal cut-offs to be determined. Methods: Thirty-four individual CSF samples and three different CRMs where analyzed for T-tau, P-tau, A beta 42 and A beta 40, using up to seven different commercially available methods. For A beta 40 and A beta 42 a mass spectrometry-based procedure was also employed. Results: There were strong pairwise correlations between the different methods (Spearman's p>0.92) for all investigated analytes and the CRMs were not distinguishable from the individual samples. Conclusions: This study shows that the CRMs are commutable for the different assays for A beta 42. For the other analytes the results show that it would be feasible to also produce CRMs for these. However, additional studies are needed as the concentration interval for the CRMs were selected based on A beta 42 concentrations only and did in general not cover satisfactory large concentration intervals for the other analytes.

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