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Cerebrospinal fluid (CSF) biomarkers are increasingly used for diagnosis of Alzheimer’s disease in research, clinical trials and clinical settings. As for other biochemical measurements, variability between laboratories for these biomarkers may be monitored by proficiency testing programs, where participating laboratories use their local routine methods to analyze test samples shipped from a central laboratory. In this review, we summarize the results from the last years’ pilot proficiency programs and describe the ongoing standardization efforts in this area. Global proficiency testing for CSF biomarkers is now fully established. It will continue to play an important part in the standardization of measurements that is a prerequisite for the broad-scale future implementation of CSF biomarkers.

Item does not contain fulltext Cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease (AD) are increasingly used in clinical settings, research and drug trials. However, their broad-scale use on different technology platforms is hampered by the lack of standardization at the level of sample handling, determination of concentrations of analytes and the absence of well-defined performance criteria for in vitro diagnostic or companion diagnostic assays, which influences the apparent concentration of the analytes measured and the subsequent interpretation of the data. There is a need for harmonization of CSF AD biomarker assays that can reliably, across centers, quantitate CSF biomarkers with high analytical precision, selectivity and stability over long time periods. In this position paper, we discuss reference procedures for the measurement of CSF AD biomarkers, especially amyloid beta42 and tau. We describe possible technical approaches, focusing on a selected reaction monitoring mass spectrometry assay as a candidate reference method for quantification of CSF amyloid beta42. 01 augustus 2012

SUMMARY Neurodegenerative and neuroinflammatory conditions are major causes of morbidity and mortality worldwide. To support the development of effective treatments, and to increase the understanding of disease mechanisms, much focus has been directed towards identifying biomarkers of treatment effects in these conditions. Cerebrospinal fluid has been extensively utilized for this purpose. For example, researchers now have candidate cerebrospinal fluid biomarkers to identify pharmacodynamic effects on β-amyloid metabolism in Alzheimer’s disease, and downstream effects on axonal loss in several neurological diseases. Here we describe candidate markers that potentially may be implemented as pharmacodynamic markers in clinical trials and routine clinical settings.