| The Alzheimer's Association external quality control program for cerebrospinal fluid biomarkers. | |
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MedLine Citation:
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PMID: 21784349 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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BACKGROUND: The cerebrospinal fluid (CSF) biomarkers amyloid β (Aβ)-42, total-tau (T-tau), and phosphorylated-tau (P-tau) demonstrate good diagnostic accuracy for Alzheimer's disease (AD). However, there are large variations in biomarker measurements between studies, and between and within laboratories. The Alzheimer's Association has initiated a global quality control program to estimate and monitor variability of measurements, quantify batch-to-batch assay variations, and identify sources of variability. In this article, we present the results from the first two rounds of the program. METHODS: The program is open for laboratories using commercially available kits for Aβ, T-tau, or P-tau. CSF samples (aliquots of pooled CSF) are sent for analysis several times a year from the Clinical Neurochemistry Laboratory at the Mölndal campus of the University of Gothenburg, Sweden. Each round consists of three quality control samples. RESULTS: Forty laboratories participated. Twenty-six used INNOTEST enzyme-linked immunosorbent assay kits, 14 used Luminex xMAP with the INNO-BIA AlzBio3 kit (both measure Aβ-(1-42), P-tau(181P), and T-tau), and 5 used Meso Scale Discovery with the Aβ triplex (AβN-42, AβN-40, and AβN-38) or T-tau kits. The total coefficients of variation between the laboratories were 13% to 36%. Five laboratories analyzed the samples six times on different occasions. Within-laboratory precisions differed considerably between biomarkers within individual laboratories. CONCLUSIONS: Measurements of CSF AD biomarkers show large between-laboratory variability, likely caused by factors related to analytical procedures and the analytical kits. Standardization of laboratory procedures and efforts by kit vendors to increase kit performance might lower variability, and will likely increase the usefulness of CSF AD biomarkers. |
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Authors:
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Niklas Mattsson; Ulf Andreasson; Staffan Persson; Hiroyuki Arai; Sat Dev Batish; Sergio Bernardini; Luisella Bocchio-Chiavetto; Marinus A Blankenstein; Maria C Carrillo; Sonia Chalbot; Els Coart; Davide Chiasserini; Neal Cutler; Gunilla Dahlfors; Stefan Duller; Anne M Fagan; Orestes Forlenza; Giovanni B Frisoni; Douglas Galasko; Daniela Galimberti; Harald Hampel; Aase Handberg; Michael T Heneka; Adrianna Z Herskovits; Sanna-Kaisa Herukka; David M Holtzman; Christian Humpel; Bradley T Hyman; Khalid Iqbal; Mathias Jucker; Stephan A Kaeser; Elmar Kaiser; Elisabeth Kapaki; Daniel Kidd; Peter Klivenyi; Cindy S Knudsen; Markus P Kummer; James Lui; Albert Lladó; Piotr Lewczuk; Qiao-Xin Li; Ralph Martins; Colin Masters; John McAuliffe; Marc Mercken; Abhay Moghekar; José Luis Molinuevo; Thomas J Montine; William Nowatzke; Richard O'Brien; Markus Otto; George P Paraskevas; Lucilla Parnetti; Ronald C Petersen; David Prvulovic; Herman P M de Reus; Robert A Rissman; Elio Scarpini; Alessandro Stefani; Hilkka Soininen; Johannes Schröder; Leslie M Shaw; Anders Skinningsrud; Brith Skrogstad; Annette Spreer; Leda Talib; Charlotte Teunissen; John Q Trojanowski; Hayrettin Tumani; Robert M Umek; Bianca Van Broeck; Hugo Vanderstichele; Laszlo Vecsei; Marcel M Verbeek; Manfred Windisch; Jing Zhang; Henrik Zetterberg; Kaj Blennow |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Alzheimer's & dementia : the journal of the Alzheimer's Association Volume: 7 ISSN: 1552-5279 ISO Abbreviation: Alzheimers Dement Publication Date: 2011 Jul |
Date Detail:
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Created Date: 2011-07-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101231978 Medline TA: Alzheimers Dement Country: United States |
Other Details:
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Languages: eng Pagination: 386-395.e6 Citation Subset: IM |
Copyright Information:
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Copyright © 2011 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Clinical Neurochemistry Laboratory, Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry, the Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Mölndal, Sweden. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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