NCCLS Ep9-A在方法学比较中的应用及两种促甲状腺激素测定方法的比较  

Application of the NCCLS Ep9-A in Method Comparison of Two Methods in Determination of the Patient＇s TSH

作　　者：康钦炯[1] 车辉娟[2] 马锦 

机构地区：[1]西安交通大学医学院第一附属医院检验科,西安710061 [2]西安市中心医院血液病研究所,西安710002 [3]蓝田县人民医院检验科,陕西蓝田710500

出　　处：《现代检验医学杂志》2010年第5期79-80,共2页Journal of Modern Laboratory Medicine

摘　　要：目的 对电化学发光免疫法与放免法检测血清促甲状腺激素作对比分析.方法 依据美国国家临床实验室标准协会（NCCLS）EP9-A文件,每天取临床样本8份,分别用两种方法测定样本促甲状腺激素含量,共7 d,记录检验结果,去除离群点,计算线性方程和相关系数,行偏倚估计.结果 两种方法测定促甲状腺激素的回归方程为Y= 0.890 5X＋0.152 6,相关系数r2=0.973 1,TSH浓度为0.27,4.20,21.00 μU/ml时,两种方法的预期相对偏倚为3.70%,11.19%,12.10%.结论 电化学发光法与放免法在测定血清促甲状腺激素时,测定结果的相对偏倚随其浓度增加而增加.Objective To evaluate the efficiencies of electrochemiluminescent assay （ECL） and Radioimmunoassay（RIA） for detecting of the levels of serum TSH. Methods According to the NCCLS approved guideline EP9-A,56 patient samples were analyzed in duplicate using both ECL and RIA in 7 days. The coefficient of correlation was calculated as well as the bia between the methods. Results The computed line was described by the equation：Y = 0. 890 5X＋ 0. 152 6,r^2= 0. 973 1. The bias between ECL and RIA methods were 3.70% at 0. 27 μU/ml,11. 19% at 4.24 μU/ml and 12.10% at 21.00 μU/ml. Conclusion In determination of the patient＇s TSH,the bias between ECL an RIA went up when the concentration of TSH was increased.

关 键 词：促甲状腺激素 电化学发光免疫法 放免法 

分 类 号：R392.11[医药卫生—免疫学]