The Korean journal of internal medicine · 2011
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
Аннотация
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 Thyretain™ 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) (r(s) = 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.
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 Thyretain™ 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) (r(s) = 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.
Предметные рубрики MeSH
AdultAnimalsBiological AssayBiomarkersCHO CellsCase-Control StudiesCricetinaeCricetulusCross-Sectional StudiesFemaleGenes, ReporterGraves DiseaseHashimoto DiseaseHumansImmunoglobulins, Thyroid-StimulatingLuciferasesMaleMiddle AgedPostpartum ThyroiditisPredictive Value of TestsProtein BindingRadioimmunoassayReceptors, ThyrotropinRecombinant Fusion ProteinsRepublic of KoreaSensitivity and SpecificityThyroiditis, SubacuteTransfection