Objective To establish a convenient direct assay method of determining thyrotropin receptor autoantibody (TRAb) in sera from patients with autoimmune thyroid disease ( AITD) by Indirect Enzyme-Linked Immunosorbent Assay ( ELISA) , using new recombinant human TSH receptor ectodomain (hTSHRecd) to determine TRAb.Methods Serum samples were drawn from 59 female patients with GD hyperthyroidism(23 cases for first diagnosis) and 63 female patients with primary hypothyroidism in disease group , 43 of non-AITD(thyroid cyst or adenoma , with normal thyroid function ) in control group and 50 female healthy individuals ( normal control group ) .The novel assay, an ELISA using the rhTSHRecd we prepared previously , was compared to the conventional radio receptor assay (RRA).Results By ELISA, the optical density value (OD450) in two controls of the healthy individuals and the thyroid cyst or adenoma patients was 0.27 ±0.12 and 0.32 ±0.26, respectively, and it was 0.96 ±0.78, 0.48 ±0.39 in GD hyperthyroidism and hypothyroidism patients respectively .Both of TRAbs in GD hyperthyroidism and hypothyroidism groups were significantly higher than those of the two control groups (GD t1 =6.79, t2 =6.30;hypothyroidism t1 =4.27, t2 =3.26, all P<0.01).TRAb positive rate of AITD patients determined by ELISA and RRA was 76.27%and 81.36%in GD hyperthyroidism group , 86.96%and 91.30%in GD hyperthyroidism for first diagnosis , and 34.92%and 39.68%in hypothyroidism group, respectively, and the differences were not significant (χ2 value was 0.57, 0.00, 0.57, respectively, all P>0.05).The two assays correlated closely(r=0.577925, P<0.05).Conclusion rhTSHRecd correlates well with the serum of AITD patients .Compared with RRA , ELISA is characterized of being highly efficient , convenient , cheap and no isotope pollution, which may be superior to RRA for clinical TRAb assay .%目的应用重组人促甲状腺素受体胞外段（hTSHRecd）蛋白在自身免疫性甲状腺病（AITD）患者中用以间接酶联免疫吸附法（ELISA）检测TSH受体抗体（TRAb），建立一种简便快捷、敏感性及特异性均高的新的TRAb测定方法。方法病例组：女性，Graves甲亢（ GD）患者59例，其中初诊23例；原发性甲状腺功能减退患者63例。对照组：非AITD甲状腺病（甲状腺囊肿或腺瘤，甲状腺功能正常）43例；正常对照50例。将重组hTSHRecd蛋白稀释成10μg/mL，包被酶标板，利用间接ELISA法测定上述各组样本血清TRAb，以放射受体分析（ RRA）检测法为对照。结果间接ELISA法测定TRAb，各组OD450值分别为：正常对照组0．27±0．12，非AITD对照组0．32±0．26，GD甲亢组0．96±0．78，甲减组0．48±0．39。 GD甲亢及甲减组与两个对照组相比均有显著性差异（GD甲亢t1＝6．79，t2＝6．30；甲减t1＝4．27，t2＝3．26，均P＜0．01）。用ELISA法和RRA法在AITD患者组中检测TRAb的阳性率分别为：GD甲亢组76．27％、81．36％，经比较无显著性差异（χ2＝0．57，P＞0．05）；初诊GD甲亢组86．96％、91．30％，经比较无显著性差异（χ2＝0．00，P＞0．05）；甲减组34．92％、39．68％，经比较无显著性差异（χ2＝0．57，P＞0．05）。用两种方法测得的TRAb活性值有相关性（r＝0．577925，P＜0．05）。结论重组hTSHRecd蛋白与AITD患者血清有良好的反应性。间接ELISA法检测高效、简便、费用低，无同位素污染，在作为临床常规检验中优于RRA。
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