国产化学发光免疫分析系统检测甲状腺激素的性能评价  

Performance evaluation of chemiluminescence immunoassay system for detecting thyroid hormone

作　　者：袁帅[1] 裘宇容[1] 何宗忠[2] 

机构地区：[1]南方医科大学南方医院检验科,广东广州510515 [2]广州军区广州总医院一五七分院检验科,广东广州510515

出　　处：《热带医学杂志》2016年第9期1119-1122,1148,共5页Journal of Tropical Medicine

摘　　要：目的探讨国产全自动化学发光分析仪检测促甲状腺激素（TSH）、游离三碘甲状腺原氨酸（FT3）、游离甲状腺素（FT4）、总三碘甲状腺原氨酸（T3）、总甲状腺素（T4）的精密度、线性、灵敏度、稳定性及与比对系统的结果可比性。方法参照美国国家临床实验室标准化协会CLSI的EP5-A2、EP6-A、EP17-A、EP9-A2、及EP12-A2文件分别对此化学发光免疫分析系统的精密度、线性、灵敏度及该系统和罗氏分析系统结果的可比性进行评价,同时探讨两个系统结果的临床一致率。结果 TSH、FT3、FT4、T3、T4五个项目批内精密度的CV从1.09%-5.16%,总精密度的CV从3.22%-7.55%;TSH、T3、T4均线性相关性R〉0.99;5个项目的分析灵敏度均小于厂商宣称;TSH功能灵敏度为0.006 2μIU/ml浓度梯度的天间总CV为11.2%;五个项目的在机稳定性优良,9个随机时间点的相对偏差均〈±10%;方法学对比中,TSH、FT3、FT4、T3、T4五个项目的相关系数R为别为0.9864、0.9341、0.9658、0.9113及0.9489。五个项目的阴性一致率从96.55%-98.62%,阳性一致率从96.05%-98.31%,总一致率从96.27%-98.46%。结论该国产化学发光免疫分析系统的甲功五项各方面性能优良,适合临床实验室的推广使用。Objective To evaluate the precision, linearity, sensitivity, and stability of the detection of thyroid stimulating hormone（TSH）, free triiodothyronine（FT3）, free tetraiodothyronine（FT4）, triiodothyronine（T3） and tetraiodothyronine（T4） of domestic chemiluminescence immunoassay system. Methods The precision, linearity, sensitivity and concordance were evaluated according to CLSI EP5-A2, EP6-A, EP17-A, EP9-A2 and EP12-A2 guidelines. Besides, all results were also compared with Electrochemical luminescence immunoassay system. Results The CVs of TSH, FT3, FT4, T3 and T4 were in a range from 1.09% to 5.16% for within-run precision, and from 3.22% to 7.55% for total imprecision.The value of linearity correlation for TSH, T3 and T4 were all more than 0.99. Estimated sensitivity was less than the manufacturer claim. In TSH function sensitivity test, the total CV was 11.2% at 0.006 2 μIU / ml. The onboard stability was good, and relative bias was within ±10%. In comparison of two methods, the R values of the correlation on TSH,FT3, FT4, T3 and T4 were 0.9864, 0.9341, 0.9658, 0.9113 and 0.9489, respectively. The negative concordance was form 96.55% to 98.62%, the positive concordance was from 96.05% to 98.31% and the total concordance was from96.27% to 98.46%. Conclusions The performance evaluation of domestic chemiluminsecence immunoassay system for determination of all aspects of thyroid hormone assays on chemiluminsecence immunoassay system was obviously acceptable and suitable for promotion application of in clinical laboratory.

关 键 词：甲状腺激素 化学发光分析仪 性能评价 

分 类 号：R446[医药卫生—诊断学]