磁分离-酶标记-化学发光法测定促甲状腺素的应用

目的评估促甲状腺素(TSH)在甲状腺机能亢进症(甲亢)中的诊断地位。方法采用高灵敏度的化学发光免疫夹心法检测TSH,比较TSH在诊断甲亢时的ROC曲线下面积。结果化学发光免疫分析(CLIA)的灵敏度为0.01mIU/L,批内、批间精密度CV值分别为2.39%和4.09%,与质控靶值回归方程y=0.9284x-0.0551(r2:0.9984)、与游离三碘甲状腺原氨酸(FT3)和游离甲状腺素(FT4)相比,TSH具有最大的ROC曲线下面积及最小的交叉重叠范围。在甲状腺机能减退症(甲减)的诊断中,TSH与FT4具有相同的诊断效率(P>0.05),而在甲亢的诊断中,TSH比FT3、FT4更有效(P<0.05)。结论由于高灵敏度与高精密度方法学的应用,可检测到低浓度的TSH值,使TSH不但应用于甲减的诊断,而且也能应用于甲亢,甚至亚临床型及潜在型甲亢或甲减的诊断。

Application of magnetic separation-enzymatic labeled-chemiluminecence technology to measure thyrotropin

Objective To evaluate the analytical performance of TSH for diagnostic accuracy in hyperthyroidism.Methods Utilizing highly sensitive "third generation" chemiluminescent immunoenzymatic sandwich assay to measure TSH concentrations, matched the areas under receiver operator characteristic (ROC) curves.Results The functional sensitivity was 0.01 mIU/L, the intraassay and interassay imprecision were 2.39% and 4.09%. The assay showed good linearity across the quality control target data Y=0.928 4X-0.055 1 (r 2=0.998 4) TSH had the largest ROC value and the least overlapping range among the FT_3 and FT_4, which in the normal,hyperthyroidism,hypothyroidism groups.TSH and FT_4 were equal in their diagnostic validity in hypothyroidism (P>0.05), TSH had an advantage over FT_3,FT_4 among hyperthyroidism(P<0.05).Conclusion Since sensitive and precise methods become available, low TSH concentrations can be detected.CLIA method has dramatically expanded the clinical role of TSH to identify not only hypothyroidism but also hyperthyroidism even subclinical and latent hyperthyroidism or hypothyroidism.