光激化学发光系统测定孕妇促甲状腺激素的性能评价  

Performance evaluation of light initiated chemiluminescence system for the determination of thyroid stimulating hormone among pregnant women

作　　者：钱俊[1] 胡德宇[1] 张向辉 宋芳 赵卫国 

机构地区：[1]上海交通大学医学院国际和平妇幼保健院,上海200030 [2]博阳生物科技(上海)有限公司,上海201210

出　　处：《检验医学》2013年第5期412-415,共4页Laboratory Medicine

摘　　要：目的比较光激化学发光(LiCA)系统和电化学发光(ECL)系统测定孕妇促甲状腺激素(TSH)的结果,评价国产LiCA TSH检测试剂盒的性能。方法依据《体外诊断试剂临床研究指导原则》及美国国家临床生化学院(NACB)准则,采用LiCA和ECL 2种试剂盒分别测定孕妇TSH血清样本384份,对结果进行统计学分析;同时评估LiCA TSH检测试剂盒的分析敏感性、功能敏感性、批内精密度、线性、回收率和干扰。结果 2种试剂盒定量测定TSH结果高度相关,临床符合率差异无统计学意义(P>0.05);LiCA TSH检测试剂盒分析敏感性、功能敏感性分别为0.001 1和0.017μIU/mL,高、低浓度质控品(QCH和QCL)批内精密度为1.42%和1.55%,回收率为97.01%和101.57%,线性分析显示Y=24.58X-22.9(r=0.998,P<0.05),250 mg/dL血红蛋白、500 mg/dL甘油三酯和10 mg/dL胆红素对检测结果无干扰。结论 LiCA与进口ECL系统定量测定孕妇TSH的性能无差异,适合临床应用。Objective To compare the determination results of thyroid stimulating hormone（TSH） by light initiated chemiluminescence （LiCA） system and electro-chemiluminescence （ECL） system among pregnant women, and evaluate the performance of domestic LiCA TSH kit. Methods Referring to IVD Clinic Research Guideline and the National Academy of Clinical Biochemistry （NACB） guideline, the serum samples of 384 pregnant women were determined by LiCA and ECL systems respectively, and the results were analyzed statistically. Meanwhile, the analytical sensitivity, functional sensitivity, within-run precision, linearity, recovery and interference of LiCA TSH kit were evaluated. Results There were high correlations in quantitative determination of TSH between the 2 systems with no statistical significance （ P 〉 0. 05 ）. The analytical sensitivity and functional sensitivity of LiCA TSH kit were 0. 001 1 and 0. 017 μIU/mL. The within-run precisions of high-level and low-level quality controls （QCH and QCL） were 1.42% and 1.55% , and the recoveries were 97.01% and 101.57%. The linearity analysis showed Y = 24.58X -22.9 （ r = 0. 998, P 〈 0.05 ）. 250 mg/dL hemoglobin, 500 mg/dL triglyceride and 10 mg/dL bilirubin had no interference to the determination results. Conclusions There is no significant difference between LiCA system and import ECL system for the quantitative determination of TSH among pregnant women. LiCA is suitable to the clinical application.

关 键 词：促甲状腺激素 光激化学发光 性能评价 孕妇 

分 类 号：R446.61[医药卫生—诊断学]