两种仪器检测自身免疫性甲减患者血清促甲状腺激素结果的比较评价

Comparison of serum TSH in patients with autoimmune hypothyroidism detected by BIOTYG-I and Roche E601

目的:探讨两种免疫分析系统检测自身免疫性甲状腺功能减退(甲减)患者血清促甲状腺激素(TSH)结果的一致性。方法:采用宝太BIOT-YG-I与罗氏E601免疫分析系统,检测80例自身免疫性甲减患者和40例正常人血清的TSH水平,通过Kappa检验分析两种系统检测结果的一致程度,并利用线性回归分析两种系统定量检测TSH的相对偏差。结果:两种系统检测TSH结果的符合率及一致性较高;两系统间TSH定量测定结果直线相关性良好(r≥0.975),在相应医学参考水平浓度测定结果的相对偏差均可被临床接受。结论:两种免疫分析系统检测TSH的结果一致性较高。

Objective： To compare the results of TSH serum samples in patients with autoimmune hypothyroidism detected by two different immune analyze systems BIOT-YG-I and Roche E601. Methods：TSH in serum samples from 80 patients with autoimmune hypothyroidism and 40 normal controls were quantified by BIOT-YG-I and Roche E601 systems. Kappa statistic was used to analyze the agreement between the results from two immune analyze systems. The relatively deviation at medical reference level of the quantitative results of TSH were further studied using linear regressive analysis. Results： The quantitative results from two immune analyze systems presents good accordance rate and the agreement as well as a significant linear correlation （r≥0.975）. TSH quantitative results from two systems are both clinically acceptable at medical reference level. Conclusion：The consistency of two immune analyze systems is high for detecting TSH serum.