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用“第三代”化学发光免疫分析“夹心法”,评估化学发光检测 TSH的实验性能。结果显示该法精密度 :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 1m IU /L ,交叉污染率 <0 .0 1%,与 RIA法对比试验 Y=0 .8942 X+0 .2 0 31(r=0 .986 7)。因此 ,化学发光法具高灵敏度和高特异性 ,使测得的 TSH量不但能区分甲减 ,且能用于诊断甲亢 ,甚至亚临床型或潜在型甲状腺功能亢进或减退。
The “third generation” chemiluminescence immunoassay “sandwich method” was used to evaluate the performance of chemiluminescence in detecting TSH. The results showed that the precision of the method: Intra-and inter-batch CV were 2.08 ~ 2.74% and 3.85 ~ 4.43%. The recovery rate was 100.6%, the sensitivity was 0.1m IU / L, the cross-contamination rate was <0.1%, and the comparison with RIA method was Y = 0.8842 X + 0.2201 (r = 0.986 7). Therefore, the chemiluminescence method with high sensitivity and specificity, the measured amount of TSH can not only distinguish hypothyroidism, and can be used to diagnose hyperthyroidism, and even subclinical or latent hyperthyroidism or diminished.