重组人甲状腺球蛋白检测TgAb间接ELISA法的建立及其初步应用

目的:探讨用重组人甲状腺球蛋白(hTg)建立检测甲状腺球蛋白抗体(TgAb)的间接ELISA法及其临床意义。方法:用该法测定300例健康体检者(正常对照组)和各种甲状腺疾病患者484例;其中桥本甲状腺炎(HT)219例,Graves’病(GD)212例(初诊91例、复诊121例),非自身免疫性甲状腺疾病(AITD)患者53例。结果:确立本法正常界限值为0.74(A405值),血清TgAb水平HT组与正常对照组、非AITD组、GD组相比差异均有统计学意义(均P<0.01);GD组与正常对照组、非AITD组相比差异均有统计学意义(P<0.05或P<0.01);非AITD组与正常对照组相比差异无统计学意义(P>0.05)。HT、GD初诊、GD复诊患者的阳性率分别为70.8%、38.8%和28.6%,3类非AITD患者阳性率均不超过5.3%。结论:以重组hTg为抗原建立检测TgAb的ELISA法有助于各种甲状腺疾病的临床鉴别。

Establishment of an Indirect ELISA Using Recombinant Human Thyroglobulin for Detecting TgAb and Its Preliminary Application

Objective: To explore the method of indirect enzyme-linked immunosorbent assay (ELISA) with recombinant prokaryotic thyrogloblin for measuring TgAb and its clinical significance. Methods: Three hundreds health sera samples were measured using ELISA to verify cut-off values,and 484 sera samples from patients with thyroid diseases were measured with the same metod which included 219 HT,121 untreated GD,91 treated GD,and 53 nonautoimmune thyroid disease. Results: The cut-off value of TgAb in normal control group was 0.74 using ELISA method. The TgAb value in HT was higher than that in normal control group,non-AITD and GD groups,respectively. The TgAb value in GD was higher than that in normal and non-AITD groups. There was no significant difference in TgAb value between non-AITD and normal groups. The positive rates in HT,untreated GD,treated GD and non-AITD were 70.8%,38.8%,28.6%,less than 5.3%,respectively. Conclusion: ELISA with recombinant hTg to detect TgAb can be used in identifying thyroid diseases.