{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T01:22:09Z","timestamp":1783560129658,"version":"3.55.0"},"reference-count":25,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,10,29]],"date-time":"2024-10-29T00:00:00Z","timestamp":1730160000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Endocrinol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Thyroid-blocking immunoglobulins (TBI) are present in 10%\u201315% of patients with autoimmune thyroid disease (AITD). TBI affect thyroid function. The analytical performance of a novel TBI bioassay was evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Sera from AITD patients were tested with a cell-based TBI reporter bioassay (Thyretain<jats:sup>\u00ae<\/jats:sup>) with the expression of a luciferase transgene as readout and a new \u201cTurbo\u2122\u201d TBI bioassay with a readout based on a cyclic AMP-activated luciferase. All samples were also run on two TSH-R binding immunoassays. A Passing\u2013Bablok regression, a Bland\u2013Altman plot, and user\/lot comparisons were performed. In addition, dose\u2013response curves for Turbo and Thyretain were fitted using serial dilutions, and half-maximal and 80% inhibitory concentrations (IC<jats:sub>50<\/jats:sub>\/IC<jats:sub>80<\/jats:sub>) were compared.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 1,011 unselected AITD patients, 131 patients (212 samples) were TBI positive. Of the 212 samples, 149 (70.3%), 47 (22%), and 16 (7.5%) were hypothyroid, euthyroid, and hyperthyroid, respectively. The three thyrotropin receptor antibody (TSH-R-Ab) assays were negative in 90 controls devoid of autoimmune thyroid disorders. In contrast, the Turbo cyclic adenosine 3\u2032,5\u2032-monophosphate (cAMP) TBI, Thyretain TBI, and the binding assays detected TBI in 212 (100%), 168 (79%), and 138\/180 (65%) samples, respectively (<jats:italic>p<\/jats:italic>&amp;lt; 0.001). Turbo highly correlated with thyroid function (<jats:italic>p<\/jats:italic>&amp;lt; 0.001). The percentage inhibition in both Turbo and Thyretain correlated with TSH-R-Ab binding assay positivity (both <jats:italic>p<\/jats:italic>&amp;lt; 0.001). The two bioassays correlated (<jats:italic>r<\/jats:italic> = 0.8, <jats:italic>p<\/jats:italic>&amp;lt; 0.001), and the Bland\u2013Altman plot displayed no significant bias (0.24). Values scatter with slight systemic deviation between TBI mean values of 10%\u201350% inhibition, with higher Turbo than Thyretain results. Intra-assay validation demonstrated adequate precision with a very low coefficient of variation (average CV 5.4%) and lower CV with samples with a high inhibitory effect (CV<jats:sub>Average<\/jats:sub>= 1.7% for a sample with 95% inhibition Thyretain). CV did not differ between users (<jats:italic>p<\/jats:italic> = 0.35) and lots (<jats:italic>p<\/jats:italic> = 0.121). The IC<jats:sub>50<\/jats:sub>\/IC<jats:sub>80<\/jats:sub> values were 1.55 ng\/mL\/3.48 ng\/mL for Turbo and 6.76 ng\/mL\/18.46 ng\/mL for Thyretain, respectively, demonstrating the markedly higher sensitivity of Turbo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The novel, easy-to-perform, rapid, and reliable Turbo TSH-R blocking bioassay detected significantly more TBI than the established immunoassays, emphasizing its higher analytical performance and clinical utility in the management of patients with AITD.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fendo.2024.1463379","type":"journal-article","created":{"date-parts":[[2024,10,29]],"date-time":"2024-10-29T04:37:30Z","timestamp":1730176650000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":6,"title":["A novel bioassay for thyroid-blocking 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