临床化学方法验证与表格化管理  

Method Validation and Tabular Management in Clinical Chemistry Laboratory

作　　者：邱玲[1] 程歆琦[1] 鄢盛恺[1] 沈瑛[1] 刘茜[1] 刘荔[1] 刘福成[1] 葛增梅[1] 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院检验科,北京100730

出　　处：《现代检验医学杂志》2006年第4期5-9,共5页Journal of Modern Laboratory Medicine

摘　　要：目的 建立一套简便实用的临床化学方法验证操作流程和表格化管理系统．方法 采用可溯源多水平线性校准物测定的方法进行校准验证，采用连续5d每天测定4次高低两水平血清的方法检测精密度，采用连续5d依次测定高值和三个低值血清的方法检测样品探针携带污染，采用连续5d每天测定8例病人血清的方法进行两方法之间的比对，选择50例健康人验证项目的参考范围。结果 以血清清蛋白（ALB）为例，校准验证备测定点与靶值的偏差均在±5％以内。r=1．000，定量检测下限为0．4g／L）高、低水平批内变异分别为0．74%和0．77%，总变异分别为0．90％和0．85％，样本携带污染为-0．1％，两台仪器比对。r=0．995。斜率为1．027。截距0．130。平均百分偏差为-5．10%。对方法参数进行调整后，r=0．997。斜率1．015。截距0．043。平均百分偏差为2．41％．50例健康人ALB测定的参考范围为35．0～54．6g／L．结论 试探作程序可以基本上满足临床化学实验室方法验证的需求。通过表格化管理可以规范实验流程，方便结果分析，有利于提高实验室管理的工作水平。Objective To develop a convenient and practical workflow and tabular management system for method validation. Methods To determine traceable multi-levels calibrators for calibration verification. To analyze within-run and total CV by measuring high and low level quality control serums four times per day in five days. To detect the carry over of sample probe by determining one high level and three low level quality control serums continuously in five days. Method comparison and bias estimation were performed by analyzing eight patients serum per day using both test method and comparison method in five days. To verify the reference range interval by analyzing 50 healthy samples. Results Taking ALB as an example,the biases of the measured values of calibrators were all within 5% of their target values for representation in the calibration curve（r=1. 000）. The limit of quantitation was 0. 4g/L. Within CVs of the high and low level quality control serums were 0. 74% and 0. 77% ,total CVs were 0. 90% and 0. 85%. The carry over was -0. 1%. Method comparison result showed a good correlation between the test method and the comparison method （r=0. 995,slope=1. 027,Y-intercept =0. 130,bias %= 5. 10%; after modification,r= 0. 997,slope=1. 015,Y-intercept= 0. 043,bias%= 2. 411%）. The reference range was 35.0～54. 6g/L（mean±3s）. Conclusion This workflow is simple and appropriate for method validation in clinical chemistry laboratory. Tabular management is also practical and useful for standardization and management in clinical chemistry laboratory.

关 键 词：临床化学 方法验证 实验室管理 

分 类 号：R446.112[医药卫生—诊断学]