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The Alzheimer's Association QC program for CSF biomarkers

 

BACKGROUND


The CSF biomarkers tau and amyloid ß (Aß) show promise as tools in the diagnostic work-up patients with suspected Alzheimer’s disease (AD) and to monitor treatment effects in AD clinical trials. However, recent multi-center studies have shown that the levels of these CSF biomarkers vary between different research centers and laboratories. This variation in CSF biomarker levels between laboratories complicates multicenter research studies and trials and also precludes the introduction of generally applicable cut-off levels in clinical routine. The variation in CSF biomarker levels between centers is probably the result of variations in pre-analytical procedures (e.g. lumbar puncture procedure and CSF sample processing), analytical procedures, as well as batch-to-batch variation in the biomarker assays.

AIM


The aim of the QC program is to standardize CSF biomarker measurements between both research and clinical laboratories. This will increase the analytical precision and improve the longitudinal stability for biomarker measurements. The program will allow direct comparisons of biomarker levels between laboratories and, thus, between publications.

STUDY DESIGN


The program is run by the Clinical Neurochemistry Laboratory in Gothenburg, Sweden in conjunction with the Alzheimer's Association. Biotech companies and a number of reference laboratories, including the ADNI biomarker core, are also represented. Both research and clinical CSF laboratories as well as pharmaceutical companies are enrolled in the program.

The Alzheimer’s Association QC program is open for laboratories performing CSF biomarker analyses for clinical diagnosis on a routine basis,
as well as for research laboratories and pharmaceutical companies performing studies on CSF biomarkers in clinical studies or trials on a regular basis.

The program is open for generally (commercially) available assay formats (FUJIREBIO, EUROIMMUN/ADx and IBL ELISA´s ,Luminex assays, Meso-Scale V-PLEX, LUMIPULSE and COBAS Elecsys assays), but not for in-house assays.The program can be extended to other assays in the future (If you like to participate with another assay use this link).The basic principle is that QC samples (aliquots of pooled CSF) are sent out to the participating laboratories for CSF biomarker analyses, after which biomarkers levels are entered into a report form online. In the QC program, 2 different QC samples are sent out to the participating laboratories for each round (3 rounds per year). In addition, one QC sample will be analyzed each round (an aliquot of the same pool), to evaluate the longitudinal stability.  

The final report for each QC round includes information on the measured biomarker levels for the individual laboratory and, for comparison, the mean and variation in biomarker levels across all laboratories involved in the program. In addition, the longitudinal stability in CSF biomarker levels for the individual laboratory expressed as percent deviation over time will be reported. 

RESULTS


The QC program was launched in November 2009. At present more than 80 laboratories are participating. Two view results from the completed rounds click here.

JOIN THE STUDY !

To join the study, please contact Staffan Persson at NeurochemistryLab@neuro.gu.se
To download a detailed study protocol and/or to download a detailed study report form click here.

 

Kaj Blennow, MD, PhD        Henrik Zetterberg, MD, PhD
Professor                           Ass. Professor

 

 

 

 

 

Page Manager: Staffan Persson|Last update: 11/17/2017
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