The Alzheimer's Association external quality control program for cerebrospinal fluid biomarkers

被引：329

作者：

Mattsson, Niklas ^{[1
]}

Andreasson, Ulf ^{[1
]}

Persson, Staffan ^{[1
]}

Arai, Hiroyuki ^{[2
]}

Batish, Sat Dev ^{[3
]}

Bernardini, Sergio ^{[4
]}

Bocchio-Chiavetto, Luisella ^{[5
]}

Blankenstein, Marinus A. ^{[6
]}

Carrillo, Maria C. ^{[7
]}

Chalbot, Sonia ^{[8
]}

Coart, Els ^{[9
]}

Chiasserini, Davide ^{[10
]}

Cutler, Neal ^{[11
]}

Dahlfors, Gunilla ^{[12
]}

Duller, Stefan ^{[13
]}

Fagan, Anne M. ^{[14
]}

Forlenza, Orestes ^{[15
,16
]}

Frisoni, Giovanni B. ^{[5
]}

Galasko, Douglas ^{[17
]}

Galimberti, Daniela ^{[18
]}

Hampel, Harald ^{[19
]}

Handberg, Aase ^{[20
]}

Heneka, Michael T. ^{[21
]}

Herskovits, Adrianna Z. ^{[22
]}

Herukka, Sanna-Kaisa ^{[23
]}

Holtzman, David M. ^{[14
]}

Humpel, Christian ^{[24
]}

Hyman, Bradley T. ^{[22
]}

Iqbal, Khalid ^{[8
]}

Jucker, Mathias ^{[25
,26
]}

Kaeser, Stephan A. ^{[25
,26
]}

Kaiser, Elmar ^{[27
]}

Kapaki, Elisabeth ^{[28
]}

Kidd, Daniel ^{[29
]}

Klivenyi, Peter ^{[30
]}

Knudsen, Cindy S. ^{[20
]}

Kummer, Markus P. ^{[21
]}

Lui, James ^{[31
]}

Llado, Albert ^{[32
]}

Lewczuk, Piotr ^{[33
]}

Li, Qiao-Xin ^{[34
]}

Martins, Ralph ^{[31
]}

Masters, Colin ^{[34
]}

McAuliffe, John ^{[3
]}

Mercken, Marc ^{[35
]}

Moghekar, Abhay ^{[36
]}

Luis Molinuevo, Jose ^{[32
]}

Montine, Thomas J. ^{[37
]}

Nowatzke, William ^{[11
]}

O'Brien, Richard ^{[36
]}

机构：

[1] Univ Gothenburg, Sahlgrenska Univ Hosp, Clin Neurochem Lab,Inst Neurosci & Physiol, Dept Psychiat & Neurochem,Sahlgrenska Acad, Molndal, Sweden

[2] Tohoku Univ, Inst Dev Aging & Canc, Dept Geriatr & Gerontol, Sendai, Miyagi 980, Japan

[3] Athena Diagnost Inc, Worcester, MA USA

[4] Univ Roma Tor Vergata, Dept Biochim Clin, Rome, Italy

[5] IRCCS Ctr S Giovanni di Dio Fatebenefratelli, Brescia, Italy

[6] Vrije Univ Amsterdam Med Ctr, Dept Clin Chem, Amsterdam, Netherlands

[7] Alzheimers Assoc, Chicago, IL USA

[8] New York State Inst Basic Res Dev Disabil, Dept Neurochem, Staten Isl, NY USA

[9] Innogenetics, Ghent, Belgium

[10] Univ Perugia, Ctr Memory Disturbances, Lab Clin Neurochem, Neurol Sect, I-06100 Perugia, Italy

[11] Worldwide Clin Trials, King Of Prussia, PA USA

[12] Karolinska Univ Hosp, Karolinska Univ Lab, Dept Clin Chem, Stockholm, Sweden

[13] JSW Life Sci GmbH, Grambach, Austria

[14] Washington Univ, Sch Med, Dept Neurol, Alzheimers Dis Res Ctr,Hope Ctr Neurol Disorders, St Louis, MO 63110 USA

[15] Univ Sao Paulo, Fac Med, Lab Neurosci LIM 27, Dept Psychiat, Sao Paulo, Brazil

[16] Univ Sao Paulo, Fac Med, Lab Neurosci LIM 27, Inst Psychiat, Sao Paulo, Brazil

[17] Univ Calif San Diego, Sch Med, Dept Neurosci, La Jolla, CA 92093 USA

[18] Univ Milan, Dept Neurol Sci, Milan, Italy

[19] Goethe Univ Frankfurt, Dept Psychiat Psychosomat Med & Psychotherapy, Frankfurt, Germany

[20] Aarhus Univ Hosp, Aarhus Hosp, Dept Clin Biochem, DK-8000 Aarhus, Denmark

[21] Univ Bonn, Klin Neurowissensch, Neurol Klin & Poliklin, D-5300 Bonn, Germany

[22] Harvard Univ, MassGen Inst Neurodegenerat Dis, Massachusetts Gen Hosp, Sch Med,Massachusetts Alzheimer Dis Res Ctr, Charlestown, MA USA

[23] Univ Eastern Finland, Kuopio Univ Hosp, Dept Neurol, Kuopio, Finland

[24] Innsbruck Med Univ, Lab Psychiat & Expt Alzheimers Res, Innsbruck, Austria

[25] Univ Tubingen, Dept Cellular Neurol, Hertie Inst Clin Brain Res, Tubingen, Germany

[26] DZNE German Ctr Neurodegenerat Dis, Tubingen, Germany

[27] Heidelberg Univ, Sect Geriatr Psychiat, Heidelberg, Germany

[28] Univ Athens, Eginit Hosp, Dept Neurol 1, Athens 11528, Greece

[29] Janssen Alzheimer Immunotherapy Res & Dev, San Francisco, CA USA

[30] Univ Szeged, Dept Neurol, Szeged, Hungary

[31] Edith Cowan Univ, Ctr Excellence Alzheimers Dis Res & Care, Sch Exercise Biomed & Hlth Sci, Perth, WA, Australia

[32] Hosp Clin Barcelona, Alzheimers Dis & Other Cognit Disorders Unit, Neurol Serv, Inst Invest Biomed August Pi & Sunyer IDIBAPS, Barcelona, Spain

[33] Univ Klinikum Erlangen, Dept Psychiat & Psychotherapy, Erlangen, Germany

[34] Univ Melbourne, Neuropathol Res Grp, Mental Hlth Res Inst, Melbourne, Vic, Australia

[35] J&J, Janssen Pharmaceut, Beerse, Belgium

[36] Johns Hopkins Sch Med, Dept Neurol, Baltimore, MD USA

[37] Univ Washington, Dept Pathol, Seattle, WA 98195 USA

[38] Univ Ulm, Dept Neurol, D-7900 Ulm, Germany

[39] Mayo Clin, Alzheimers Dis Res Ctr, Rochester, MN USA

[40] Radboud Univ Nijmegen, Dept Neurol, Alzheimer Ctr Nijmegen, Donders Inst Brain Cognit & Behav,Med Ctr, NL-6525 ED Nijmegen, Netherlands

[41] Radboud Univ Nijmegen, Dept Lab Med, Alzheimer Ctr Nijmegen, Donders Inst Brain Cognit & Behav,Med Ctr, NL-6525 ED Nijmegen, Netherlands

[42] IRCCS Fdn S Lucia, Rome, Italy

[43] Univ Penn, Med Ctr, ADNI Biomarker Core, Dept Pathol & Lab Med, Philadelphia, PA 19104 USA

[44] Akershus Univ Hosp, Ctr Lab Med, Dept Clin Biochem, Oslo, Norway

[45] Univ Gottingen, Dept Neurol, D-3400 Gottingen, Germany

[46] Meso Scale Discovery, Gaithersburg, MD USA

来源：

ALZHEIMERS & DEMENTIA | 2011年 / 7卷 / 04期

关键词：

Alzheimer's disease; Cerebrospinal fluid; Biomarkers; External assurance; External control; Proficiency testing; MILD COGNITIVE IMPAIRMENT; AMYLOID-BETA PEPTIDES; TAU-PROTEINS; PHOSPHORYLATED TAU; XMAP TECHNOLOGY; CSF BIOMARKERS; DISEASE; PREDICTION; MARKERS; BETA-AMYLOID((1-42));

D O I：

10.1016/j.jalz.2011.05.2243

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background: The cerebrospinal fluid (CSF) biomarkers amyloid beta (A beta)-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 A beta, 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 Molndal 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 A beta-(1-42), P-tau(181P), and T-tau), and 5 used Mesa Scale Discovery with the A beta triplex (A beta N-42, A beta N-40, and A beta N-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. (C) 2011 The Alzheimer's Association. All rights reserved.

引用

页码：386 / 395

页数：10

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