总蛋白双缩脲法单试剂盒与双试剂盒检测结果的一致性评估  

Consistency Evaluation of Total Protein Biuret Method Single Kit and Double Kit Test Results

作　　者：范婵[1] 刘艳婷[1] 赵印 肖光军[1] 杨娜[1] 李祥坤[1] 曹丹 FAN Chan;LIU Yan-ting;ZHAO Yin;XIAO Guang-jun;YANG Na;LI Xiang-kun;CAO Dan(Department of Laboratory Medicine,Suining Central Hospital,Suining 629000,Sichuan,China;Department of Laboratory Medicine,Xinjin County Chinese Medicine HospitaI,Xinjin 611430,Sichuan,China)

机构地区：[1]遂宁市中心医院检验科,四川遂宁629000 [2]新津县中医院检验科,四川新津611430

出　　处：《医学信息》2018年第20期152-154,共3页Journal of Medical Information

摘　　要：目的探讨总蛋白双缩脲法单试剂盒与双试剂盒检测结果的一致性。方法参照美国临床和实验室标准协会(CLSI)EP9-A2文件的要求,以双试剂盒为参比方法、单试剂盒为待评方法,使用患者新鲜血浆标本进行方法比对及偏倚评估。结果回归方程Y=1.0064X+0.2168,相关系数r=0.9984,不同医学决定水平处的偏倚均小于我国卫生行业标准《WS/T 403-2012临床生物化学检验常规项目分析质量指标》所规定的总允许误差的1/2。结论总蛋白双缩脲法单试剂盒与双试剂盒的检测结果具有良好的一致性,差异临床可接受,其检测报告可使用相同的参考区间,但仍建议临床实验室使用双试剂盒检测患者样本。Objective To investigate the consistency of the results of the total protein biuret method single kit and double kit.Methods According to the requirements of the American Society for Clinical and Laboratory Standards（CLSI）EP9-A2 document,the double kit were used as the reference method,the single kit was used as the method to be evaluated,and the patient＇s fresh plasma samples were used for method comparison and bias evaluation.Results The regression equation Y=1.0064X＋0.2168,the correlation coefficient r=0.9984,the bias at different medical decision levels is less than the total specified in China＇s health industry standard “WS/T 403-2012 Clinical Biochemical Inspection Conventional Project Analysis Quality Index”.Allow 1/2 of the error.Conclusion The results of single kit and double kit of total protein biuret method were in good agreement with each other,the difference was acceptable in clinic.The same reference range could be used for the test report,but it was still recommended that the clinical laboratory should use double kit to detect the patient sample.

关 键 词：总蛋白 双缩脲法 偏倚评估 一致性 

分 类 号：R446.1[医药卫生—诊断学]