对比分析化学发光免疫法与免疫放射测量法

A comparative study of chemiluminescence immunoassay method and immunoradiometric assay method

目的 比较化学发光免疫分析（CLI）与免疫放射测量分析（IRMA）检测血清促甲状腺激素（TSH）在临床应用中的作用。方法 分别用CLI和IRMA对83例临床初诊怀疑甲状腺机能亢进（甲亢）患者的血清TSH进行检测和对比分析。结果 这两种方法的测定值具有高度相关性（r=0.9081，P<0.001）， CLI诊断甲亢的灵敏度和特异性为70.6%和84.4%；IRMA的灵敏度和特异性为93.2%和51.1%，没有优劣之分，但存在系统偏差，CLI特异性较好，IRMA灵敏性较高。结论 对于甲亢与甲状腺功能正常的鉴别，化学发光免疫分析与免疫放射测量分析具有相似的能力。

Objective To compare the validity of chemiluminescence immunoassay (CLI) and immunoradiometric assay (IRMA) in determining Thyroid-stimulating hormone for the purpase of differentiating hyperthyroidism from euthyroidism. Methods Serum TSH levels of 83 patients with suspected hyperthyroidism, determined by the 2 methods were compared and analyzed. Results The values from the 2 methods were closely correlated with each other (r=0.9081, P<0.001). The sensitivity and specificity of TSH values in diagnosis of hyperthyroidism was 70.6% and 84.4% respectively by CLI and was 93.2% and 51.1% respectively by IRMA. There was no significant difference between TSH values measured by these 2 methods, but CLI proved to be of higher specificity and IRMA of higher sensitivity. Conclusion The level by CLI and IRMA is equivalent in differentiating hyperthyroidism from euthyroidism, in spite of the discrepancy between the two methods, there might be false positive results in IRMA but negative ones in CLI.