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首页> 外文期刊>Endocrine journal >Clinical Evaluation of 3rd Generation Assay for Thyrotropin Receptor Antibodies: The M22-biotin-based ELISA Initiated by Smith
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Clinical Evaluation of 3rd Generation Assay for Thyrotropin Receptor Antibodies: The M22-biotin-based ELISA Initiated by Smith

机译：促甲状腺素受体抗体第三代测定的临床评价：Smith提出的基于M22-生物素的ELISA

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Recently a new procedure for measuring serum TSH receptor (TSHR) autoantibody (TRAb) was reported by Smith et al. in which the autoantibodies inhibit binding of a human monoclonal thyroid stimulating antibody M22 (labeled with biotin) to TSHR-coated ELISA plate wells (pTRAb_(3rd) assay). The aim of this study was to compare the performance of pTRAb_(3rd) assay with pTRAb_(2nd) assay based on inhibition of TSH-biotin binding to TSHR-coated ELISA plate wells. In addition, we evaluated the applicability of TRAb3rd assay to discriminate between untreated Graves' disease (GD) and painless thyroiditis (PT). Analysis of sera from 230 healthy controls indicated that only 1 (0.43%) gave inhibition of M22-binding values of greater than 15% (32.8% inhibition). To define the clinical cut-offpoint for a positive serum with autoantibodies to the TSHR, we performed receiver operating characteristic curve of the data from 244 untreated GD and three different control groups for pTRAb_(3rd) assay. With a sensitivity of 99.6% at a cut-off of 14.5%, 22.0% and 22.0% inhibition of M22 binding, the specificity of healthy controls without PT, with PT and with PT excluding postpartum PT and PT during remission of GD was 99.6%, 96.6% and 97.5%, respectively. The pTRAb_(3rd) assay was closely correlated to pTRAb_(2nd) assay in the 244 untreated Graves' sera (r = 0.911). The pTRAb_(3rd) assay detected 243 of 244 (99.6%) untreated GD, whereas 9.2% of PT and 6.7% of the subacute thyroiditis (SAT) were detectable. In contrast, pTRAb_(2nd) assay detected 242 of 244 (99.2%) Graves' same sera, while 16.8 % from PT's same sera and 13.3% from SAT were detectable. In conclusion, pTRAb_(3rd) assay has significantly (p = 0.0026) superior diagnostic accuracy for GD and PT, compared to that of pTRAb_(2nd) assay.
机译：最近，Smith等报道了一种测量血清TSH受体（TSHR）自身抗体（TRAb）的新方法。其中自身抗体抑制人单克隆甲状腺刺激抗体M22（用生物素标记）与TSHR包被的ELISA板孔的结合（pTRAb_（3rd）测定）。这项研究的目的是基于抑制TSH-生物素与TSHR包被的ELISA板孔的结合，比较pTRAb_（3rd）测定法与pTRAb_（2nd）测定法的性能。此外，我们评估了TRAb3rd检测方法在区分未治疗的Graves病（GD）和无痛性甲状腺炎（PT）方面的适用性。对来自230名健康对照者的血清进行的分析表明，只有1（0.43％）的M22结合值抑制率大于15％（32.8％的抑制率）。为了定义带有TSHR自身抗体的阳性血清的临床临界值，我们对244个未治疗的GD和三个不同对照组的数据进行了pTRAb_（3rd）测定的受试者工作特征曲线。对M22结合的抑制率分别为14.5％，22.0％和22.0％时，灵敏度为99.6％，健康对照者在没有PT，有PT和有PT且不包括产后PT和GD缓解期间PT的情况下的特异性为99.6％。 ，分别为96.6％和97.5％。在244个未经处理的Graves血清中，pTRAb_（3rd）分析与pTRAb_（2nd）分析紧密相关（r = 0.911）。 pTRAb_（3rd）分析检测到244种未经治疗的GD中有243种（99.6％），而可检测到9.2％的PT和6.7％的亚急性甲状腺炎（SAT）。相比之下，pTRAb_（2nd）检测可检测到244个中的242个（99.2％）Graves的相同血清，而PT的相同血清的16.8％和SAT的13.3％。总之，与pTRAb_（2nd）分析相比，pTRAb_（3rd）分析对GD和PT具有显着（p = 0.0026）更高的诊断准确性。

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