Clinical evaluation of 3rd generation assay for thyrotropin receptor antibodies: The M22-biotin-based ELISA initiated by Smith
Clinical evaluation of 3rd generation assay for thyrotropin receptor antibodies: The M22-biotin-based ELISA initiated by Smith
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DOI：
10.1507/endocrj.52.525
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发表时间：
2005-10-01
影响因子：
2
通讯作者：
Tanaka, M
中科院分区：
文献类型：
--
作者：
Kamijo, K;Ishikawa, K;Tanaka, M
最近，Smith等人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促甲状腺抗体M22（生物素标记）与TSHR包被的ELISA板孔的结合（pTRAb（第3次）测定）。本研究的目的是比较pTRAb3rd法和pTRAb（2nd）法在抑制tsh -生物素与tshrr包被的ELISA板孔结合上的性能。此外，我们评估了TRAb(3)检测在鉴别未经治疗的Graves病（GD）和无痛性甲状腺炎（PT）方面的适用性。230例健康对照血清分析显示，只有1例（0.43%）对m22结合值的抑制大于15%（32.8%）。为了确定TSHR自身抗体阳性血清的临床分界点，我们对244例未经治疗的GD和3个不同对照组的数据进行了受试者工作特征曲线（pTRAb（3rd）测定）。在M22结合抑制率为14.5%、22.0%和22.0%的临界值下，敏感性为99.6%，未接受PT治疗、接受PT治疗、不包括产后PT治疗和GD缓解期PT治疗的健康对照组的特异性分别为99.6%、96.6%和97.5%。244例未经治疗的Graves血清中pTRAb(3)与pTRAb(2)密切相关（r = 0.911）。pTRAb（3rd）检测检测出244例未经治疗的GD中的243例（99.6%），而PT的9.2%和亚急性甲状腺炎（SAT）的6.7%被检测到。相比之下，pTRAb(2)法在244例Graves相同血清中检出率为242例（99.2%），而在PT相同血清中检出率为16.8%，在SAT中检出率为13.3%。综上所述，pTRAb(3)法对GD和PT的诊断准确率显著高于pTRAb(2)法（p = 0.0026）。
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 pTRAb3rd 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 TRAb(3rd) 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-off point 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.