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The Alzheimer's Association QC program for CSF and blood biomarkers

Alzheimer’s Association Quality Control (QC) Program brings together laboratories across the globe with the aim of standardizing the measurement of Alzheimer's biomarkers. The program aims to monitor site-to-site and batch-to-batch CSF and plasma test variation to help participating laboratories to synchronize their procedures and enable them to see how their local performance of a given assay compares relative to other participants' using the same assay. This external QC program comes free of charge to participating laboratories.

About the program

The Alzheimer’s Association external quality control (QC) program aims to monitor site-to-site and batch-to-batch Alzheimer Disease (AD) biomarker test variation and help participating laboratories to synchronize their procedures and enable them to see how their local performance of a given assay compares relative to other participant’s using the same assay. This external QC program comes free of charge to participating laboratories.

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 multi-center studies have shown that the levels of these CSF biomarkers vary between different research centres and laboratories. This variation in CSF biomarker levels between laboratories complicates multicentre research studies and trials and also precludes the introduction of generally applicable cut-off levels in clinical routine. The variation in biomarker levels between centres is probably the result of variations in pre-analytical procedures (e.g. lumbar puncture procedure and sample processing), analytical procedures, as well as batch-to-batch variation in the biomarker assays.

Aim

The QC program started 2009 with the aim to standardize CSF biomarker measurements between both research and clinical laboratories and since 2019 the program extended to also include blood biomarkers. The program help participating laboratories to synchronize their procedures and enable them to see how their local performance of a given assay compares relative to other participants' using the same assay. 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. Both research and clinical laboratories as well as pharmaceutical companies are enrolled in the program.
The Alzheimer’s Association QC program is open for laboratories performing CSF and plasma biomarker analyses for clinical diagnosis on a routine basis, as well as for research laboratories and pharmaceutical companies performing studies on CSF and plasma biomarkers in clinical studies or trials on a regular basis.

The program is open for generally (commercially) available assays. The basic principle is that QC samples (aliquots of pooled CSF or plasma) are sent out to the participating laboratories for 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 analysed 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 biomarker levels for the individual laboratory expressed as percent deviation over time will be reported. Note that the aim of this is to standardize biomarkers measurements between laboratories and not to identify the “true” biomarker level or similar.

Results

The QC program was launched in November 2009. At present more than 100 laboratories are participating.

View results from the completed rounds >>> 

Publications

CSF biomarker variability in the Alzheimer's Association quality control program
Mattsson N, Andreasson U, Persson S, et al.
Alzheimers Dement. 2013;9(3):251–261. 

The Alzheimer's Association external quality control program for cerebrospinal fluid biomarkers
Mattsson N, Andreasson U, Persson S, et al.
Alzheimers Dement. 2011;7(4):386–395.e6. 

Participants

List of leading Investigators of laboratories that are active in The Alzheimer's Association QC Program (PDF) >>> 

Join the program

For questions regarding the program and/or if you would like to participate in the Alzheimer´s Association QC Program, please contact us by e-mail:  NeurochemistryLab@neuro.gu.se

NOTICE! It is not too late to join the Alzheimer’s Association QC program.

Frequently asked questions