{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T16:19:16Z","timestamp":1787242756588,"version":"build-2736575974"},"reference-count":45,"publisher":"The Endocrine Society","issue":"5","license":[{"start":{"date-parts":[[2024,7,19]],"date-time":"2024-07-19T00:00:00Z","timestamp":1721347200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"QuidelOrtho Corp"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,4,22]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Bioassays provide information on the functionality of thyrotropin receptor antibodies (TSH-R-Ab) and thus may offer more clinical utility than binding assays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>In this prospective, blinded, US-based study, the clinical performance of several TSH-R-Ab assays was compared.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>US endocrinology clinic.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Subjects<\/jats:title>\n                    <jats:p>One hundred sixty-two unselected, consecutive, well-documented patients with various thyroid diseases and healthy controls.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention(s)<\/jats:title>\n                    <jats:p>Blinded TSH-R-Ab measurements.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcome Measure(s)<\/jats:title>\n                    <jats:p>Sensitivity and specificity of 4 TSH-R-Ab assays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The 4 TSH-R-Ab assays were negative in all 42 patients without autoimmune thyroid disease (AITD). In 104 patients with Graves\u2019 disease (GD), irrespective of the disease duration, TSH-R-Ab positivity was present in 65 (63%), 67 (65%), and 87 (84%) for the Cobas and Immulite binding assays and stimulatory TSH-R-Ab [thyroid-stimulating immunoglobin (TSI)] bioassay, respectively (TSI vs Immulite P &amp;lt; .0025, TSI vs Cobas P &amp;lt; .0009). Fifteen newly diagnosed GD patients were all positive in the TSI bioassay, but only 11 (73%) were positive in the Cobas and Immulite binding assays. Nine GD patients with biochemical subclinical hyperthyroidism were TSI-positive but Immulite- and Cobas-negative. Two GD patients were blocking TSH-R-Ab [thyroid-blocking immunoglobin (TBI)]-positive and TSI-negative, and the Immulite and Cobas were positive in both. Additional serum samples from AITD patients that consisted of 30 TBI-positive and 10 TSI-positive samples were blindly tested in the binding assays. Only 6 of the 10 TSI-positive samples were positive in both binding assays, and 30 and 28 of the TBI-positive samples were positive in the Cobas and Immulite assays, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Binding TSH-R-Ab assays are less sensitive than TSI bioassays and are not specific for stimulating antibodies. Measuring the function of TSH-R-Ab in a bioassay can provide useful information to clinicians.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgae448","type":"journal-article","created":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T17:54:28Z","timestamp":1721238868000},"page":"e1619-e1624","source":"Crossref","is-referenced-by-count":9,"title":["US-based, Prospective, Blinded Study of Thyrotropin Receptor Antibody in Autoimmune Thyroid Disease"],"prefix":"10.1210","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8218-2789","authenticated-orcid":false,"given":"Mark A","family":"Lupo","sequence":"first","affiliation":[{"name":"Thyroid & Endocrine Center of Florida , Sarasota, FL 34239 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul D","family":"Olivo","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Molecular Pathogenesis, Washington University School of Medicine , St. Louis, MO 63110 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian","family":"Luffy","sequence":"additional","affiliation":[{"name":"Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg-University Medical Center , Mainz 55131 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Wolf","sequence":"additional","affiliation":[{"name":"Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg-University Medical Center , Mainz 55131 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0441-430X","authenticated-orcid":false,"given":"George J","family":"Kahaly","sequence":"additional","affiliation":[{"name":"Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg-University Medical Center , Mainz 55131 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