{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T19:18:18Z","timestamp":1793042298854,"version":"4.5.0"},"reference-count":22,"publisher":"Walter de Gruyter GmbH","issue":"10","license":[{"start":{"date-parts":[[2023,5,1]],"date-time":"2023-05-01T00:00:00Z","timestamp":1682899200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,9,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_cclm-2023-0072_abs_001\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Antibodies against glutamic acid decarboxylase isoform 65 (GAD-Ab) have been found in different severe neurological conditions associated with altered synthesis of \u03b3-aminobutyric acid (GABA). Serum GAD-Ab can be found in up to 90\u202f% of patients with type 1 diabetes mellitus (T1DM), mostly at relatively low concentrations, while high concentrations of GAD-ab are thought to be more frequently associate to a neurological condition, with levels 100-folds higher than those found in T1DM. Although CSF testing is recommended when suspecting a GAD-associated neurological syndrome, no commercial immunoassay is validated for this use and no cut-off is internationally recognized to support the diagnosis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2023-0072_abs_002\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this study we validated CSF testing of GAD-Ab on an automated chemiluminescence (CLIA) immunoassay that had previously shown good agreement with ELISA on serum.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2023-0072_abs_003\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We tested 43 CSF from patients with typical GAD-associated neurological disorders and patients with other neurological conditions, identifying a clinical cut-off of 18\u202fkIU\/L that discriminated GAD-disease with an area under the curve (AUC) of 0.921. CLIA showed good analytical performances on repeatability and recovery tests in CSF and confirmed an excellent agreement with ELISA.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2023-0072_abs_004\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>GAD-Ab associated neurological disorders are rare but CSF testing for GAD-Ab is a common request for neurologists when suspecting an insidious autoimmune central nervous system disease. CLIA platforms are expected to be increasingly adopted in clinical laboratories due to their flexibility and reliability, therefore studies on decisional levels should be implemented for improving the interpretation and utilization of laboratory data.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/cclm-2023-0072","type":"journal-article","created":{"date-parts":[[2023,4,28]],"date-time":"2023-04-28T12:14:14Z","timestamp":1682684054000},"page":"1802-1807","source":"Crossref","is-referenced-by-count":4,"title":["Analytical evaluation of a GAD65 antibodies chemiluminescence immunoassay for CSF in neurological syndromes"],"prefix":"10.1515","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7748-773X","authenticated-orcid":false,"given":"Giulia","family":"Musso","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine , University-Hospital of Padova , Padova , Italy"},{"name":"Department of Medicine-DIMED , University of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Zoccarato","sequence":"additional","affiliation":[{"name":"Neurology Unit, Ospedale Sant\u2019Antonio , University-Hospital of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicoletta","family":"Gallo","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , University-Hospital of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1284-7885","authenticated-orcid":false,"given":"Andrea","family":"Padoan","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , University-Hospital of Padova , Padova , Italy"},{"name":"Department of Medicine-DIMED , University of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Cosma","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , University-Hospital of Padova , Padova , Italy"},{"name":"QI.LAB.MED , Spin-off of the University of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Zuliani","sequence":"additional","affiliation":[{"name":"Department of Neurology , Ospedale San Bortolo , Vicenza , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piera","family":"De Gaspari","sequence":"additional","affiliation":[{"name":"Neuroimmunology Group , Pediatric Research Institute \u201cCitt\u00e0 della Speranza\u201d , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Pegoraro","sequence":"additional","affiliation":[{"name":"Department of Neurosciences DNS , University of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0270-1711","authenticated-orcid":false,"given":"Mario","family":"Plebani","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , University-Hospital of Padova , Padova , Italy"},{"name":"Department of Medicine-DIMED , University of Padova , Padova , Italy"},{"name":"QI.LAB.MED , Spin-off of the University of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Basso","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , University-Hospital of Padova , Padova , Italy"},{"name":"Department of Medicine-DIMED , University of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2023,5,1]]},"reference":[{"key":"2024012315074081694_j_cclm-2023-0072_ref_001","doi-asserted-by":"crossref","unstructured":"Graus, F, Saiz, A, Dalmau, J. 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