自建新生儿苯丙氨酸荧光定量检测系统的应用评价  

Application Evaluation of Self-built Fluorescent Quantitative Determination System for Neonatal Phenylalanine

作　　者：谭玉华 刘海平[2] 张正武 卢顺舵 吴木清 彭中华 朱延彬 吴道贫 

机构地区：[1]广州市丰华生物工程有限公司,广州510730 [2]佛山市妇幼保健院佛山市新生儿筛查中心,广东佛山528000

出　　处：《现代检验医学杂志》2010年第2期66-68,共3页Journal of Modern Laboratory Medicine

基　　金：广东省科技计划项目（2008年粤港关键领域重点突破项目,2008A030600003）;广州经济技术开发区、广州高新技术产业区、广州出口加工区、广州保税区科技项目（广州市生物产业发改委资金配套类,2008Ss-P126）;广东省科技计划项目（省国际合作项目,2009B050700047）.

摘　　要：目的为推动国内新生儿苯丙酮尿症（PKU）筛查技术的发展和新生儿PKU筛查的普及，自建新生儿苯丙氨酸荧光定量检测系统，并对自建系统进行基本的分析性能进行评价。方法参考美国临床实验室标准化委员会（NCCLS）文件和相关文献，以labsystems配套检测系统作为可溯源参比系统，对自建系统的精密度、灵敏度、线性进行评价，并用临床样本进行比对试验和偏倚评估，回归相关系数大于0．975，偏倚以中国卫生部临检中心苯丙氨酸室间质评的1／4允许系统误差（靶值±30％）作为检测系统可比性的临床接受标准；通过检测1353例正常新生儿样本，建立参考值，并对引用参考值进行确认。结果自建检测系统分析内、分析间不精密度均小于15％；检测灵敏度为0．55mg／dl；在1．00～15．00mg／dl内，回归系数r=0．9991；与参比系统比对试验回归方程为Y（自建）=1．0078X（参比）-0．0416，r=0．9987，相对偏倚小于7．50％。参考值可以直接引用2．00mg／dl作为切值判断。结论自建新生儿苯丙氨酸荧光定量检测系统的基本性能可以满足临床需要，值得推广应用。Objective To promote domestic neonatal phenylketonurla （PKU） screening technology development, diffuse neonatal PKU screening,establish a fluorescence quantitative detection system for neonatal phenylalanlne ,and evaluate the performance of the self-built system. Methods Referencing to the National Committee for Clinical Laboratory Standards （NCCLS） evaluation protocols and pertinent literature,comparison test and bias estimation for self-built test system and traceable labsystems reference system. The precision, analytical sensitivity and linearity range of phenylalanine on selfbuilt test system were verificated. The correlation coefficients was above 0. 975. And 1/4 NCCL phenylalanine External Quality Assessment permitted systematic bias （target value± 30%） was used as the acceptance judge standard. The reference value was established and the labsystems kit reference value was confirmed by testing samples of 1 353 cases of normal newborns. Results Intra-assay and inter-assay coefficient of self-built system were less than 15%. The analytical sensitivity was 0. 55 mg/dl. The regression coefficient （r） was 0. 999 1 in 1.00 -15.00 mg/dl. Compared the reference system,the regression equation was Y（self-built） = 1. 007 8X（reference）-0. 041 6,r=0. 998 7,the relative bias was less than 7. 50%. 2.00 mg/dl could be directly referenced as a cut value. Conclusion Self-built fluorescent quantitative detection system for neonatal phenylalanine corresponds to clinical needs.

关 键 词：苯丙氨酸 荧光 检测系统 性能评价 

分 类 号：R392-33[医药卫生—免疫学]