荧光酶联免疫分析技术测定人甲状腺过氧化物酶抗体

目的以重组人甲状腺过氧化物酶（hTPO）为抗原建立定量检测hTPO抗体（hTPOAb）的板式荧光酶联免疫技术（FEIA），用于甲状腺疾病的临床检测。方法用该法测定326名健康人和各类甲状腺疾病患者279例，包括慢性淋巴细胞性甲状腺炎（HT）119例，初诊Graves病（GD）116例，结节性甲状腺肿28例，亚急性甲状腺炎10例，单纯性甲状腺肿6例的血清hTPOAb水平。组间比较采用秩和检验，组间阳性率的比较用，检验。结果（1）确立该法阳性切限值为第95百分位数（％）4000U／L（即hTPOAb浓度值大于4000U／L定为阳性）。（2）批内、批间变异系数（CV）分别为4．59％～6．52％、17．37％～17．45％。（3）该法与商品试剂盒雅培微粒荧光法检测同批血清hTPOAb结果显著相关（r=0．80，P〈0．01）。（4）用该法测定各类甲状腺疾病患者hTPOAb浓度值结果以中位数表示，HT为7000U／L，阳性率85．70％；初诊GD为4000U／L，阳性率39．65％；结节性甲状腺肿为4000U／L，阳性率28．57％；亚急性甲状腺炎为4000U／L，阳性率30．00％；单纯性甲状腺肿为3500U／L，阳性率0。HT患者血清hTPOAb阳性率与其他各甲状腺疾病组之间的差异有统计学意义（，=53．45，39．30，15．41和21．74，P均〈0．01）。结论该定量检测hTPOAb的FEIA应用于临床甲状腺疾病患者的血清学检查，在HT中有很高的阳性率，故可作为HT的诊断手段。

The clinical application of fluorescent-enzyme immunoassay to detect human thyroid peroxidase autoantibody quantitatively

Objective To establish a fluorescent-enzyme immunoassay (FEIA) with recombinant human thyroid peroxidase (hTPO) as the antigen. Methods Sera of 326 healthy people, 119 cases of Hashimoto's thyroiditis (HT), 116 cases of Graves disease (untreated), 28 cases of nodular goiter, 10 ca-ses of subacute thyroiditis and 6 cases of simple goiter were measured by the FEIA with recombinant hTPO as the antigen. Rrank sum test and χ~2-test were used in inter-groups. Results (1) Concentration above 4000 U/L was considered to be positive. (2) The intra-assay coefficient of variation (CV) and the inter-as-say CV were 4.59%～6.52% and 17.37%～17.45%. (3) The values measured by the FEIA were posi-tively correlated with the values measured by hTPO antibody (hTPOAb) commercial kit (r=0.80, P<0.01). (4) The concentration range of hTPOAb was showed in the form of medium. The results and the positive ratio were 7000 U/L and 85.70% in HT; 4000 U/L and 39.65% in Graves disease (untreated);4000 U/L and 28.57% in nodular goiter; 4000 U/L and 30.00% in subacute thyroiditis; 3500 U/L and zero in simple goiter. The positive ratio of HT group was much higher than that of other groups (χ~2 = 53.45,39.30, 15.41 and 21.74, all P < 0.01). Conclusions The method can be applied in the serum measure-ment of thyroid disease. HT presented the highest positive rate, therefore, the FEIA was an effective method in diagnosing HT.