Measurement batch differences and between‐batch conversion of Alzheimer's disease cerebrospinal fluid biomarker values

Batch differences in cerebrospinal fluid (CSF) biomarker measurement can introduce bias into analyses for Alzheimer's disease studies. We evaluated and adjusted for batch differences using statistical methods.

[1]  J. Trojanowski,et al.  Predicting clinical decline and conversion to Alzheimer’s disease or dementia using novel Elecsys Aβ(1–42), pTau and tTau CSF immunoassays , 2019, Scientific Reports.

[2]  S. Asthana,et al.  Effects of Simvastatin on Augmentation Index Are Transient: Outcomes From a Randomized Controlled Trial , 2019, Journal of the American Heart Association.

[3]  K. Blennow,et al.  Elecsys® Total-Tau and Phospho-Tau (181P) CSF assays: Analytical performance of the novel, fully automated immunoassays for quantification of tau proteins in human cerebrospinal fluid. , 2019, Clinical biochemistry.

[4]  K. Blennow,et al.  Biomarkers for Alzheimer's disease: current status and prospects for the future , 2018, Journal of internal medicine.

[5]  Ron Brookmeyer,et al.  Estimation of lifetime risks of Alzheimer's disease dementia using biomarkers for preclinical disease , 2018, Alzheimer's & Dementia.

[6]  C. Jack,et al.  NIA-AA Research Framework: Toward a biological definition of Alzheimer’s disease , 2018, Alzheimer's & Dementia.

[7]  Nick C Fox,et al.  Cerebrospinal fluid in the differential diagnosis of Alzheimer’s disease: clinical utility of an extended panel of biomarkers in a specialist cognitive clinic , 2018, Alzheimer's Research & Therapy.

[8]  H. Vanderstichele,et al.  Automation on an Open-Access Platform of Alzheimer’s Disease Biomarker Immunoassays , 2018, SLAS technology.

[9]  Sterling C. Johnson,et al.  The Wisconsin Registry for Alzheimer's Prevention: A review of findings and current directions , 2017, bioRxiv.

[10]  Dabao Zhang,et al.  A Coefficient of Determination for Generalized Linear Models , 2017 .

[11]  K. Blennow,et al.  CSF Aβ1-42 - an excellent but complicated Alzheimer's biomarker - a route to standardisation. , 2017, Clinica chimica acta; international journal of clinical chemistry.

[12]  K. Blennow,et al.  CSF and blood biomarkers for the diagnosis of Alzheimer's disease: a systematic review and meta-analysis , 2016, The Lancet Neurology.

[13]  K. Blennow,et al.  Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of β-amyloid (1–42) in human cerebrospinal fluid , 2016, Alzheimer's & Dementia.

[14]  Philip Scheltens,et al.  Variability of CSF Alzheimer’s Disease Biomarkers: Implications for Clinical Practice , 2014, PloS one.

[15]  F. Pasquier,et al.  Intersite variability of CSF Alzheimer’s disease biomarkers in clinical setting , 2013, Alzheimer's & Dementia.

[16]  M. Carrillo,et al.  CSF biomarker variability in the Alzheimer's Association quality control program , 2013, Alzheimer's & Dementia.

[17]  Leslie M. Shaw,et al.  Global standardization measurement of cerebral spinal fluid for Alzheimer's disease: An update from the Alzheimer's Association Global Biomarkers Consortium , 2013, Alzheimer's & Dementia.

[18]  C. Jack,et al.  Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers , 2013, The Lancet Neurology.

[19]  Noor Azina Ismail,et al.  Statistical Methods Used to Test for Agreement of Medical Instruments Measuring Continuous Variables in Method Comparison Studies: A Systematic Review , 2012, PloS one.

[20]  Leslie M. Shaw,et al.  Standardization of preanalytical aspects of cerebrospinal fluid biomarker testing for Alzheimer's disease diagnosis: A consensus paper from the Alzheimer's Biomarkers Standardization Initiative , 2012, Alzheimer's & Dementia.

[21]  Giovanni B. Frisoni,et al.  The Alzheimer’s Association external quality control program for cerebrospinal fluid biomarkers , 2011, Alzheimer's & Dementia.

[22]  Denise C. Park,et al.  Toward defining the preclinical stages of Alzheimer’s disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease , 2011, Alzheimer's & Dementia.

[23]  Robert A. Dean,et al.  Qualification of the analytical and clinical performance of CSF biomarker analyses in ADNI , 2011, Acta Neuropathologica.

[24]  M. Blankenstein,et al.  Standardization of Assay Procedures for Analysis of the CSF Biomarkers Amyloid β (1-42), Tau, and Phosphorylated Tau in Alzheimer's Disease: Report of an International Workshop , 2010, International journal of Alzheimer's disease.

[25]  K. Blennow,et al.  Lessons from Multicenter Studies on CSF Biomarkers for Alzheimer's Disease , 2010, Alzheimer's & Dementia.

[26]  C. Jack,et al.  Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade , 2010, The Lancet Neurology.

[27]  W. M. van der Flier,et al.  CSF biomarkers and incipient Alzheimer disease in patients with mild cognitive impairment. , 2009, JAMA.

[28]  W. M. van der Flier,et al.  A worldwide multicentre comparison of assays for cerebrospinal fluid biomarkers in Alzheimer's disease , 2009, Annals of clinical biochemistry.

[29]  F. Jessen,et al.  Multiplexed quantification of dementia biomarkers in the CSF of patients with early dementias and MCI: A multicenter study , 2008, Neurobiology of Aging.

[30]  P. Lewczuk,et al.  International quality control survey of neurochemical dementia diagnostics , 2006, Neuroscience Letters.

[31]  J. Morris,et al.  The Uniform Data Set (UDS): Clinical and Cognitive Variables and Descriptive Data From Alzheimer Disease Centers , 2006, Alzheimer disease and associated disorders.

[32]  W. M. van der Flier,et al.  Usefulness of longitudinal measurements of beta-amyloid1-42 in cerebrospinal fluid of patients with various cognitive and neurologic disorders. , 2006, Clinical chemistry.

[33]  Eric R. Ziegel,et al.  Generalized Linear Models , 2002, Technometrics.

[34]  D. Altman,et al.  Measuring agreement in method comparison studies , 1999, Statistical methods in medical research.

[35]  Darren George,et al.  SPSS for Windows Step by Step: A Simple Guide and Reference , 1998 .

[36]  James Lee,et al.  Comparison of variance between correlated samples , 1992, Comput. Appl. Biosci..

[37]  D. Altman,et al.  STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT , 1986, The Lancet.

[38]  Douglas G. Altman,et al.  Measurement in Medicine: The Analysis of Method Comparison Studies , 1983 .

[39]  E. Pitman.  A NOTE ON NORMAL CORRELATION , 1939 .

[40]  W. A. Morgan.  TEST FOR THE SIGNIFICANCE OF THE DIFFERENCE BETWEEN THE TWO VARIANCES IN A SAMPLE FROM A NORMAL BIVARIATE POPULATION , 1939 .

[41]  L. Poston,et al.  Extending the scope of pooled analyses of individual patient biomarker data from heterogeneous laboratory platforms and cohorts using merging algorithms. , 2016, Pregnancy hypertension.

[42]  J. Trojanowski,et al.  Comparison of xMAP and ELISA assays for detecting cerebrospinal fluid biomarkers of Alzheimer's disease. , 2012, Journal of Alzheimer's disease : JAD.

[43]  W. M. van der Flier,et al.  Variability in longitudinal cerebrospinal fluid tau and phosphorylated tau measurements , 2008, Clinical chemistry and laboratory medicine.