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

2015; Elsevier BV; Volume: 36; Issue: 9 Linguagem: Inglês

10.1016/j.neurobiolaging.2015.05.003

1558-1497

Niels Kruse, Staffan Persson, Daniel Alcolea, Justyna M.C. Bahl, Inês Baldeiras, Elisabetta Capello, Davide Chiasserini, Luisella Bocchio‐Chiavetto, Andreja Emeršič, Sebastiaan Engelborghs, Erden Eren, Tormod Fladby, Giovanni B. Frisoni, María‐Salud García‐Ayllón, Şermin Genç, Olymbia Gkatzima, Niels H. H. Heegaard, André M. Janeiro, Branislav Kováčech, H. Bea Kuiperij, Maria João Leitão, Alberto Lleó, Madalena Martins, Mafalda Matos, Hanne M. Møllergård, Flavio Nobili, Annika Öhrfelt, Lucilla Parnetti, Catarina R. Oliveira, Uroš Rot, Javier Sáez‐Valero, Hanne Struyfs, Julia T. Tanassi, Peggy Taylor, Magda Tsolaki, Eugeen Vanmechelen, Marcel M. Verbeek, Norbert Žilka, Kaj Blennow, Henrik Zetterberg, Brit Mollenhauer,

Neurological disorders and treatments

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.