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KMID : 0338420110260020179
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The Korean Journal of Internal Medicine
2011 Volume.26 No. 2 p.179 ~ p.186
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Diagnostic Value of a Chimeric TSH Receptor (Mc4)-Based Bioassay for Graves’ Disease
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Lee Ji-In
Jang Hye-Won
Kim Soo-Kyoung
Choi Joon-Young
Kim Ji-Young
Hur Kyu-Yeon
Kim Jae-Hyeon
Min Yong-Ki
Chung Jae-Hoon
Kim Sun-Wook
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Abstract
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Background/Aims: Graves’ disease (GD) is caused by thyroid-stimulating hormone receptor (TSHR) and thyroid-stimulating immunoglobulin (TSI). We used a recently introduced, technically enhanced TSI bioassay to assess its diagnostic value and determine the cut-off in patients in high iodine intake area.
Methods: In a cross-sectional setting, we collected serum from 67 patients with untreated GD, 130 with GD under treatment, 22 with GD in remission, 42 with Hashimoto’s thyroiditis, 12 with subacute thyroiditis, 20 with postpartum thyroiditis, and 93 euthyroid controls. TSI was measured using the ThyretainTM bioassay, which is based on Chinese hamster ovary cells transfected with chimeric TSHR (Mc4). TSI levels are reported as a specimen-to-reference ratio percentage (SRR%).
Results: The TSI levels in patients with GD (either treated or not) were significantly higher than those of the remaining patients (p < 0.05). The new bioassay showed a sensitivity of 97.0% and a specificity of 95.9% with a cut-off value of 123.0 SRR% for GD. A weak correlation was found between TSI and thyrotropin-binding inhibiting immunoglobulin (TBII) (rs = 0.259, p = 0.03), but no correlation was found between TSI and tri-iodothyronine or free thyroxine.
Conclusions: The Mc4-CHO bioassay showed comparable diagnostic value for GD with the conventional TBII assay. We propose a cut-off of 123.0 SRR% in areas where iodine intake is high.
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KEYWORD
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Graves disease, Immunoglobulins, thyroid-stimulating, Biological assay, Receptors, thyrotropin, Thyrotropin-binding inhibitory immunoglobulin
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