{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T04:56:24Z","timestamp":1789016184801,"version":"build-2803163510"},"reference-count":15,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,7,2]],"date-time":"2024-07-02T00:00:00Z","timestamp":1719878400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Objectives<\/jats:title><jats:p>Intravenous immunoglobulins (IVIgs) contain various autoantibodies, including those against glutamic acid decarboxylase (GADAb), a valuable biomarker of type 1 diabetes mellitus. Passive transfer of GADAb from IVIgs to patients poses a risk of misdiagnosis, and information on the specific titres of GADAb and their impact on diagnostic accuracy remains limited. This study aimed to provide further insights into the origin of GADAb detected in patient serum following IVIg infusion.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>GADAb titres in IVIg products from Japan and the United States were measured using enzyme\u2010linked immunosorbent assay\u2010based assays. For reliable quantification, GADAb titres in pooled plasma were quantified and compared with those in the IVIg products. The determined titres were used to estimate the likelihood of passively detecting acquired GADAb in individuals receiving IVIgs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>GADAbs were prevalent in IVIg products; however, the titres varied significantly among different lots and products. Importantly, IVIg\u2010derived GADAb was estimated to remain detectable in patient serum for up to 100\u2009days following a dosage of 2000\u2009mg\/kg.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Clinicians should consider that IVIg preparations may contain GADAb, which can lead to false\u2010positive results in serological assays. Careful interpretation of the assay results is key to the definitive diagnosis of type 1 diabetes mellitus.<\/jats:p><\/jats:sec>","DOI":"10.1111\/vox.13710","type":"journal-article","created":{"date-parts":[[2024,7,3]],"date-time":"2024-07-03T00:53:55Z","timestamp":1719968035000},"page":"1106-1110","source":"Crossref","is-referenced-by-count":1,"title":["Antibodies against glutamic acid decarboxylase in intravenous immunoglobulin preparations can affect the diagnosis of type 1 diabetes mellitus"],"prefix":"10.1111","volume":"119","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-7012-9985","authenticated-orcid":false,"given":"Tatsuki","family":"Miyamoto","sequence":"first","affiliation":[{"name":"Research and Development Division Japan Blood Products Organization  Kobe Hyogo Japan"},{"name":"Pharmacovigilance Division Japan Blood Products Organization  Minato\u2010ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Fukunaga","sequence":"additional","affiliation":[{"name":"Research and Development Division Japan Blood Products Organization  Kobe Hyogo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ai","family":"Munakata","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division Japan Blood Products Organization  Minato\u2010ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsushi","family":"Murai","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division Japan Blood Products Organization  Minato\u2010ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,7,2]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"European Medicines Agency.Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) \u2013 Rev.6.2022.https:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/guideline\u2010core\u2010smpc\u2010human\u2010normal\u2010immunoglobulin\u2010intravenous\u2010administration\u2010ivig\u2010rev\u20106_en.pdf. 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