2011
DOI: 10.1089/thy.2011.0056
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Similar Clinical Performance of a Novel Chimeric Thyroid-Stimulating Hormone Receptor Bioassay and an Automated Thyroid-Stimulating Hormone Receptor Binding Assay in Graves' Disease

Abstract: Similar and excellent performance was noted for the Mc4-TSAb and M22-TRAb assays in a large group of patients with GD. However, there was 9.4% discordance with regard to false negatives for GD and 3.8% discordance between the two tests with regard to false positives for PT. With regard to the relatively high rate of discordancy, a combination of both assays could reduce the presence of TSHRAb-seronegative GD.

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Cited by 30 publications
(20 citation statements)
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References 14 publications
(18 reference statements)
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“…In contrast, it amounted to about 26% (31% minus about 5% assumed cases of yet undiagnosed heart failure) in the peptide-based assay. Thus, the percentage of false-positives obtained with the novel cell-based competition ELISA compares quite well to what is found with even the most advanced assays for anti-TSH antibodies in Graves disease, 23 whereas it seems to be rather too high for the peptide-based assay.…”
Section: Discussionsupporting
confidence: 63%
“…In contrast, it amounted to about 26% (31% minus about 5% assumed cases of yet undiagnosed heart failure) in the peptide-based assay. Thus, the percentage of false-positives obtained with the novel cell-based competition ELISA compares quite well to what is found with even the most advanced assays for anti-TSH antibodies in Graves disease, 23 whereas it seems to be rather too high for the peptide-based assay.…”
Section: Discussionsupporting
confidence: 63%
“…The clinical sensitivity of the TSI method was absolute (100%), slightly higher than those previously reported for current IMAs and BAs with a similar diagnostic specificity [8,9,[28][29][30][31] (Tables 1 and 3).…”
Section: Discussionmentioning
confidence: 47%
“…We did not compare TSI Immulite with BAs, and, consequently, cannot clarify whether positive TSI in our non-GD patients were due to the presence of B-TRAb binding the N-terminal domain of the chimeric receptor or to the presence of S-TRAb. It is worth noting that a new BA is commercially available for S-TRAb [Thyretain™] [30]. Though based on chimeric receptor similar to the one used in Immulite assay, it detects only the stimulating activity (not immunoreactivity) via cAMP measurement, hence not detecting B-TRAb.…”
Section: Discussionmentioning
confidence: 99%
“…Many clinicians in Europe, advocate the use of TRAb as a cost-effective primary test in the initial workup of hyperthyroidism, as it is useful in distinguishing GD from subacute painless thyroiditis 7. Our patient had the high M22-TRAb assay done in our hospital laboratory, which has been shown to have similar and excellent performance in diagnosing patients with GD as compared with the Mc4-TSAB assay 8. Functionally, TRAb may be divided into stimulatory antibodies that stimulate the thyroid (TSAb) and inhibitory antibodies that block the action of TSH (TBAb) and neutral antibody.…”
Section: Discussionmentioning
confidence: 97%