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CSF biomarker variability in the Alzheimer's Association quality control program.

Niklas Mattsson1, Ulf Andreasson, Staffan Persson

  • 1Clinical 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. niklas.mattsson@neuro.gu.se

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|April 30, 2013
PubMed
Summary

Cerebrospinal fluid biomarkers for Alzheimer's disease (AD) show significant variability between labs. Standardization is crucial for reliable AD diagnosis and research using these important biomarkers.

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Area of Science:

  • Neuroscience
  • Biochemistry
  • Clinical Diagnostics

Background:

  • Cerebrospinal fluid (CSF) biomarkers like amyloid beta 1-42, total tau, and phosphorylated tau are increasingly vital for Alzheimer's disease (AD) research and clinical management.
  • Significant analytical variability exists in CSF biomarker measurements across and within laboratories, hindering their widespread application.

Purpose of the Study:

  • To quantify the extent and identify sources of analytical variability in CSF biomarker measurements.
  • To assess the impact of this variability on Alzheimer's disease classification.

Main Methods:

  • Analysis of data from nine rounds of the Alzheimer's Association quality control program.
  • Utilized three CSF samples analyzed by ELISA, xMAP, and electrochemoluminescence immunoassay across 84 participating laboratories.

Main Results:

  • Inter-laboratory coefficients of variation (CVs) ranged from 20% to 30%, while within-run CVs were 5% to 10%.
  • Longitudinal within-laboratory CVs (5% to 19%) varied by biomarker and laboratory, indicating assay-dependent components.
  • Variability in amyloid beta 1-42 was influenced by both kit lots and laboratories, whereas tau biomarkers were more affected by laboratory differences.

Conclusions:

  • Overall measurement variability is too high for universal biomarker cutoff values.
  • Laboratories must ensure longitudinal measurement stability and use internal cutoffs.
  • Standardization of procedures and improved kit performance are necessary to enhance the utility of CSF AD biomarkers.