Published January 1, 2015 | Version v1
Journal article Open

Validation of a quantitative cerebrospinal fluid alpha-synuclein assay in a European-wide interlaboratory study

  • 1. Univ Med Ctr Gottingen, Dept Neuropathol, D-37075 Gottingen, Germany
  • 2. Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad,Clin Neurochem Lab, Inst Neurosci & Physiol,Dept Psychiat & Neurochem, Molndal, Sweden
  • 3. Statens Serum Inst, Dept Autoimmunol & Biomarkers, DK-2300 Copenhagen S, Denmark
  • 4. Univ Coimbra, CHUC, Fac Med, CNC Ctr Neurosci & Cell Biol,Dept Neurol,Neuroche, Coimbra, Portugal
  • 5. Dept Neurosci DINOGMI, Clin Neurol Unit, Genoa, Italy
  • 6. Univ Perugia, Ctr Memory Disturbances & Alzheimers Ctr, Dept Med, Neurol Sect,Lab Clin Neurochem, I-06100 Perugia, Italy
  • 7. Univ Med Ctr, Dept Neurol, Ljubljana, Slovenia
  • 8. Univ Antwerp, Inst Born Bunge, Reference Ctr Biol Markers Dementia BIODEM, B-2020 Antwerp, Belgium
  • 9. Dokuz Eylul Univ, Hlth Sci Inst, Dept Neurosci, Izmir, Turkey
  • 10. Akershus Univ Hosp, Dept Neurol, Lorenskog, Norway
  • 11. Aristotle Univ Thessaloniki, Neurol Dept 3, GR-54006 Thessaloniki, Greece
  • 12. Inst Mol Med, Diagnost Med Mol, Genomed, Lisbon, Portugal
  • 13. Slovak Acad Sci, Inst Neuroimmunol, Bratislava, Slovakia

Description

Decreased levels of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) in Parkinson's disease and related synucleinopathies have been reported, however, not consistently in all cross-sectional studies. To test the performance of one recently released human-specific enzyme-linked immunosorbent assay (ELISA) for the quantification of aSyn in CSF, we carried out a round robin trial with 18 participating laboratories trained in CSF ELISA analyses within the BIOMARKAPD project in the EU Joint Program -Neurodegenerative Disease Research. CSF samples (homogeneous aliquots from pools) and ELISA kits (one lot) were provided centrally and data reported back to one laboratory for data analysis. Our study showed that although factors such as preanalytical sample handling and lot-to-lot variability were minimized by our study design, we identified high variation in absolute values of CSF aSyn even when the same samples and same lots of assays were applied. We further demonstrate that although absolute concentrations differ between laboratories the quantitative results are comparable. With further standardization this assay may become an attractive tool for comparing aSyn measurements in diverse settings. Recommendations for further validation experiments and improvement of the interlaboratory results obtained are given. (C) 2015 Elsevier Inc. All rights reserved.

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