Citations 2
Guidelines for the standardization of preanalytic variables for blood‐based biomarker studies in Alzheimer's disease research
O’Bryant, Sid E. , Gupta, Veer Bala , Henriksen, Kim , Jeromin, Andreas, Lista, Simone , Bazenet, Chantal, Soares, Holly , Lovestone, Simon , Hampel, Harald , Montine, Thomas J. , Blennow, Kaj , Foroud, Tatiana, Carrillo, María C. , Graff‐Radford, Neill R. , Laske, Christoph , Breteler, Monique M.B. , Shaw, Leslie M. , Trojanowski, John Q. , Schupf, Nicole , Fagan, Anne M. , Oberoi, Pankaj, Umek, Robert M., Weiner, Michael W. , Grammas, Paula , Posner, Holly, Martins, Ralph N. , groups, STAR-B and BBBIG working, Edwards, Melissa , Rissman, Robert A. , groups, STAR-B and BBBIG working, O'Bryant, Sid
Alzheimer's & Dementia | October 1, 2014 | Volume: 11 | Issue: 5 | Pages: 549-560
Abstract The lack of readily available biomarkers is a significant hindrance toward progressing to effective therapeutic and preventative strategies for Alzheimer's disease (AD). Blood‐based biomarkers have potential to overcome access and cost barriers and greatly facilitate advanced neuroimaging and cerebrospinal fluid biomarker approaches. Despite the fact that preanalytical processing is the largest source of variability in laboratory testing, there are no currently available standardized preanalytical guidelines. The current international working group provides the initial starting point for such guidelines for standardized operating procedures (SOPs). It is anticipated that these guidelines will be updated as additional research findings become available. The statement provides (1) a synopsis of selected preanalytical methods utilized in many international AD cohort studies, (2) initial draft guidelines/SOPs for preanalytical methods, and (3) a list of required methodological information and protocols to be made available for publications in the field to foster cross‐validation across cohorts and laboratories.
The Alzheimer's Association external quality control program for cerebrospinal fluid biomarkers
Mattsson, Niklas , Andréasson, Ulf , Batish, Sat Dev, Bernardini, Sergio , Bocchio‐Chiavetto, Luisella , Blankenstein, Marinus A. , Carrillo, María C. , Chalbot, Sonia, Coart, Els, Chiasserini, Davide , Cutler, Neal E., Dahlfors, Gunilla, Duller, Stefan, Fagan, Anne M. , Frisoni, Giovanni B. , Galimberti, Daniela , Hampel, Harald , Handberg, Aase , Heneka, Michael T. , Herskovits, A. Zara , Herukka, Sanna‐Kaisa , Humpel, Christian , Iqbal, Khalid , Kaeser, Stephan A. , Kaiser, Elmar, Kapaki, Elisabeth, Kidd, Daniel, Klivènyi, Péter , Knudsen, Cindy Soendersoe, Kummer, Markus P. , Lui, James, Lladó, Albert , Li, Qiao‐Xin , Martins, Ralph N. , Masters, Colin L. , McAuliffe, John C., Mercken, Marc, Moghekar, Abhay , Molinuevo, José Luís , Montine, Thomas J. , Nowatzke, William, O’Brien, Richard , Otto, Markus , Parnetti, Lucilla , Petersen, Ronald C. , Prvulovic, David, Reus, Herman P.M. de, Scarpini, Elio , Stefani, Alessandro , Schröder, Johannes , Shaw, Leslie M. , Skinningsrud, Anders, Skrogstad, Brith, Spreer, Annette, Trojanowski, John Q. , Tumani, Hayrettin , Umek, Robert M., Broeck, Bianca Van, Vanderstichele, Hugo, Vécsei, László , Blennow, Kaj , Frisoni, Giovanni B. , Persson, Staffan , Arai, Hiroyuki N. , Forlenza, Orestes Vicente , Galasko, Douglas , Holtzman, David M. , Hyman, Bradley T. , Jucker, Mathias , Lewczuk, Piotr , Paraskevas, George P. , Rissman, Robert A. , Soininen, Hilkka S. , Talib, Leda Leme , Teunissen, Charlotte E. , Verbeek, Marcel M. , Windisch, Manfred , Zhang, Jing , Zetterberg, Henrik , Parnetti, Lucilla , Molinuevo, José Luis , Masters, Colin L , Otto, Markus , Galimberti, Daniela
Alzheimer's & Dementia | July 25, 2011 | Volume: 7 | Issue: 4 | Pages: 386
BackgroundThe 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.MethodsThe 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.ResultsForty 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.ConclusionsMeasurements 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.