{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T14:53:46Z","timestamp":1776092026644,"version":"3.50.1"},"reference-count":41,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,7,6]],"date-time":"2018-07-06T00:00:00Z","timestamp":1530835200000},"content-version":"vor","delay-in-days":186,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alz &amp;amp; Dem Diag Ass &amp;amp; Dis Mo"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Cerebrospinal fluid \u03b1\u2010synuclein level is increased in sporadic Creutzfeldt\u2010Jakob disease cases. However, the clinical value of this biomarker remains to be established. In this study, we have addressed the clinical validation parameters and the interlaboratory reproducibility by using an electrochemiluminescent assay.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Cerebrospinal fluid \u03b1\u2010synuclein was quantified in a total of 188 sporadic Creutzfeldt\u2010Jakob disease and non\u2013Creutzfeldt\u2010Jakob\u2010disease cases to determine sensitivity and specificity values and lot\u2010to\u2010lot variability. Two round robin tests with 70 additional cases were performed in six independent laboratories.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A sensitivity of 93% and a specificity of 96% were achieved in discriminating sporadic Creutzfeldt\u2010Jakob disease. No differences were detected between lots. The mean interlaboratory coefficient of variation was 23%, and the intralaboratory coefficient of variations ranged 2.70%\u201311.39%. Overall, 97% of samples were correctly diagnosed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The herein validated \u03b1\u2010synuclein assay is robust, accurate, and reproducible in identifying Creutzfeldt\u2010Jakob disease cases. Thus, it is ready for implementation in the clinical practice to support the diagnosis of Creutzfeldt\u2010Jakob disease.<\/jats:p><\/jats:sec>","DOI":"10.1016\/j.dadm.2018.06.005","type":"journal-article","created":{"date-parts":[[2018,7,7]],"date-time":"2018-07-07T16:30:40Z","timestamp":1530981040000},"page":"461-470","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Interlaboratory validation of cerebrospinal fluid \u03b1\u2010synuclein quantification in the diagnosis of sporadic Creutzfeldt\u2010Jakob disease"],"prefix":"10.1002","volume":"10","author":[{"given":"Niels","family":"Kruse","sequence":"first","affiliation":[{"name":"Institute for Neuropathology, University Medical Center G\u00f6ttingen G\u00f6ttingen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Heslegrave","sequence":"additional","affiliation":[{"name":"Department of Molecular Neuroscience Institute of 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