半乳糖血症全自动筛查试剂盒的性能分析  

Performance analysis of automatic galactosemia screening kit

作　　者：孙亦彩 冯健明 徐倩 沈健 

机构地区：[1]山东省滨州市妇幼保健院新生儿疾病筛查中心,256618 [2]广东省广州市丰华生物工程有限公司

出　　处：《中国计划生育学杂志》2015年第9期620-624,639,共6页Chinese Journal of Family Planning

基　　金：国家863计划项目(2011AA02A112)

摘　　要：目的：对一种检测新生儿滤纸干血片样品中总半乳糖含量的全自动检测试剂盒进行性能分析。方法：采用荧光分析法检测总半乳糖含量，评判试剂盒的性能指标。结果：该试剂盒的有效检测范围为2．5～70mg／dl，检测试剂盒的分析灵敏度为0．1mg／dl。批内、批间的不精密度分别为≤10％与≤15％，校准品的不精密度≤20％。试剂盒在37℃放置7d后荧光值变化≤15％，稳定性好。本试剂盒检测结果与国外公司的同类试剂盒有很好的相关性，差异无统计学意义（P〉0．05）。结论：该试剂盒对比国外产品，操作简单快速，已实现自动化，适合应用于新生儿半乳糖血症大批量样本的筛查。Objective： To assess an automatic detection kit for quantitative determination of total galactose on dried blood spots of newborns, which was developed by Guangzhou Fenghua Bioengineering Co., Ltd. Methods The per formance of this kit was evaluated by quantitative determination of total galactose based on fluorescence assay. Results The effective linearity range of the kit was 2.5N 70 mg/dL, and the analytical sensitivity was not higher than 0.1 mg/ dI. The intra-assay and inter-assay coefficients of variation were no more than 10% and 15%, respectively. Coeffi cients of variation about calibrator were under 20%. When the kit was stored at 37 ℃ for 7 days, the change of fluorescence values were not higher than 15%. These results demonstrate the kit has a good stability. Moreover, it has a good correlation with those kits developed by foreign brand, with no significant difference （P〉0.05）. Conclusion As a simple and efficient automated kit, it is suitable for mass newborn screening application.

关 键 词：半乳糖血症 新生儿筛查 荧光分析法 试剂盒 出生缺陷干预 

分 类 号：R446.6[医药卫生—诊断学]