国产邻苯三酚红试剂检测尿蛋白的性能验证  

Performance verification of domestic pyrogallol red reagent in urine protein detection

作　　者：曾雅琦 陈特[1] 毕小云[1] 

机构地区：[1]重庆医科大学附属第一医院检验科,重庆400016

出　　处：《国际检验医学杂志》2013年第21期2840-2841,2843,共3页International Journal of Laboratory Medicine

基　　金：国家临床重点专科建设项目经费资助[财社2010(305)]

摘　　要：目的 评估国产邻苯三酚红试剂测定尿蛋白的分析性能.方法 收集不同尿液蛋白浓度的新鲜尿液标本,采用不精密度、回收率、最低检出限、线性范围以及临床可报告范围进行验证.结果 高、低2个浓度水平尿液样本总蛋白测定的批内CV值分别为2.34%及1.11%,批间CV值分别为3.21%及1.65%;平均回收率为97.5%,最低检出限为0.367 mg/dL,在11～298 mg/dL的浓度范围内线性良好,最大稀释倍数为20倍,临床可报告范围为11～5 960 mg/dL.结论 不精密度、回收率指标可满足临床要求,最低检出限、线性范围、最大稀释倍数及临床可报告范围可提供更好的质量保证,但高浓度标本需稀释处理.Objective To evaluate the analytical performance of domestic pyrogallol red reagent in urine protein detection. Methods Fresh urine samples of different urine protein concentration were selected. Non-precision,recovery rate,minimum delectability,linear range and clinical reportable range were adopted for verification. Results Intra-assay CV values of total protein detection of urine samples in highest and lowest concentration levels were 2.34 % and 1.11 %, respectively, and inter-assay CV values of those were 3.21 % and 1.65%, respectively. The average recovery rate was 97.5% and the minimum delectability was 0. 367 mg/dI.. Good linearity was found in the concentration range of 11-298 mg/dL and the maximum dilution ratio was 20. The clinical repo% table range was 11-5 960 mg/dL. Conclusion Non-precision and recovery rate may meet the clinical requirements. The minimum delectabilily,linear range,maximum dilution ratio and clinical reportable range can provide better quality guarantee, however, the samples of high concentration need to be diluted.

关 键 词：尿 蛋白 邻苯三酚红 性能验证 自动生化分析仪 

分 类 号：R446.1[医药卫生—诊断学]