尿微量白蛋白检测试剂盒性能评价  

Performance evaluation for urine microalbuminuria measurement kit

作　　者：解春宝[1] 传良敏[1] 罗江蓉[2] 黄燚[1] 黄文芳[1] 

机构地区：[1]四川省医学科学院四川省人民医院检验科,四川成都610072 [2]四川省医学科学院四川省人民医院急诊科,四川成都610072

出　　处：《中国卫生检验杂志》2015年第11期1770-1771,共2页Chinese Journal of Health Laboratory Technology

摘　　要：目的评价深圳迈瑞免疫比浊法检测尿微量白蛋白的性能。方法评价深圳迈瑞免疫透射比浊法检测尿微量白蛋白的正确度、日内不精密度、日间不精密度、线性范围以及最大稀释度。结果迈瑞尿微量白蛋白检测试剂盒与西门子特定蛋白分析仪及配套试剂检测结果的偏倚为0.017 5 mg/L,相关系数(r)为0.996,决定系数(r2)为0.993。精密度试验显示,迈瑞尿微量白蛋白检测试剂盒的日内不精密度为1.04%~1.17%,日间不精密度为1.74%~2.71%。线性试验显示,该试剂盒在浓度为4 mg/L^300 mg/L时呈线性。如果以回收率≤(100%±20%)作为判定标准,则最大稀释度试验显示该试剂盒的最大稀释度为30倍。结论深圳迈瑞尿微量白蛋白检测试剂盒正确度高、精密度好、线性范围宽、最大稀释度高,其性能完全能满足临床的使用要求。Objective To evaluate the performance of Shenzhen mindray immune turbidimetry for microalbuminuria measurement. Methods The accuracy, within -day imprecision, inter -day imprecision, hnearity and maximum dilution degree of the Shenzhen mindray immunoturbidimetric method in microalbuminuria measurement were evaluated. Results Between Shenz- hen mindray regent and the reagent of Siemens specific protein analyzer, the bias, correlation coefficient （r）, determination co- efficient （ r^2 ） was 0.017 5 mg/L, 0. 996 and O. 993, respectively. The accuracy test showed that within - day CV of Shenzhen mindray regent was 1.04% - 1.17%. The inter - day CV of Shenzhen mindray regent was 1.74% -2.71%. The kit was linear in the range of 4 mg/L - 300 mg/L. If the criteria was recovery ~〈 （ 100% ＋ 20% ）, the dilution test showed that the maximum dilution degree was 30 times. Conclusion Shenzhen mindray immune turbidimetry kit has good accuracy, precision, linear range, maximum dilution degree for microalbuminuria measurement, and suitable for clinical use.

关 键 词：尿微量白蛋白 性能 评价 

分 类 号：R446.12[医药卫生—诊断学]