检测系统线性验证在临床检验工作中的意义

The significance of detection systems linear verification in clinical laboratory

目的通过对实验室检测系统检测项目的线性验证，来发现检测过程中线性问题，寻找问题来源和解决问题，从而让临床医务人员了解实验室报告的结．果与谊分析物的真实浓度水平或数量或活性是怎样的线性关系。同时也体_现检测系统线性验证的重要性。方法按美国临床实验室标准化委员会（CLSI）EP6一A《定量测量方法线性评价：一种统计学方法，批准指南》的文件要求，以德国拜耳CentaurXP化学发光仪13项目为例，对谊项目进行线性验证（AMR）。结果在检测系统线性验证的过程中，出现验证通过和不通过两种情况，如果出现不通过，需要改变该项目检测的线性范围。结论通过对检测系统线性验证的过程，可以及时发现检测系统在实际工作中存在的线性缺陷和问题。从而减少误差，提醒实验室工作人员合理应用线性，指导临床工作并理解线性验证的重要性。

Objective Using Evaluation of linearity in the clinical laboratory, to find the reasons of undetable high concentrations and low concentrations or abnormale linearity, to make clinicians understand the results of the laboratory report and the true concentration level or amount of the analyte or activity linear relationshipand to demonstrate the importance of the detection system linearity verification. Methods Based on the experimental items of T3 on Bayer Centaur XP,thc experiment data were evaluated with The American clinical （CLSI） EP6- A guideline. Result There＇ re two situations in Analysis of the linear range, verified through or not, the latter needs to change its＇ linear range. Conclusions By Analysising of the linear range, we can find detection system defects and problems in practical work, reduce the error, also he alert laboratory workers reasonable application of the linear guide clinical work and understand the importance of linear validation.