化学发光测定TSH的实验评价与临床应用(英文)

EVALUATION AND CLINICAL PRACTICE OF CHEMILUMINESCENT IMMUNOASSAY DETECT THYROTROPIN

目的 :评估化学发光测定TSH的实验性能 ,拓宽TSH在临床诊断上的应用。方法 :采用“第三代”化学发光免疫分析“夹心法”。结果 :该法精密度试验批内与批间CV分别为 2 0 8- 2 74%与 3 85 - 4 43 % ,回收率10 0 6 % ,灵敏度 0 0 1mIU/L ,交叉污染率 <0 0 1% ,与RIA法对比试验Y =0 8942X + 0 2 0 31(r=0 986 7)。结论 :化学发光法能提供高灵敏度与高性能的测定TSH方法 ,同时通过TSH测定不但能区分甲状腺功能减退而且能应用于诊断甲状腺功能亢进 ,甚至亚临床型或潜在型甲状腺功能亢进或减退。

Objective: To establish the chemiluminescent immunoassays for edtection of thyroid-stimulating hormone and enlarge upon clinical diagnostic value. Methods: Using highly sensitive 'third generation' chemiluminescent immunoenzymatic 'Sandwich' assay. Results: The intraassay and interassay imprecision were 2.08-2.74% and 3.825-4.43% The average rate of spiking recovery was 100.6%. The functional sensitivity was 0.01 mIU/L. The carryover was found to be<0.01%. This assay showed good linearity across the analytical radioimmunoassay Y=0.8942X+0.203(r=0.9867). Conclusion: This assay can offer highly sensitive quantitative detect thyrotropin with which to distinguish hypothyroidism from nonthyroideal disease and applied to diagnosis hyerthyroidism even subclinical and latent hyerthyroidism or hypothyroidism.