基因扩增技术分析前质量控制的相关环节

Related Links of Quality Control before Polymerase Chain Reaction Analysis

基因扩增技术（polymerase chain reaction 简称 PCR）是近年来分子生物学水平的一种新的疾病检测手段，具有灵敏、特异、微量、简便、快速等优点，操作中影响因素颇多，质量控制难以掌控，尤其是分析前质量控制涉及环节较多，是目前实验室质量控制中最薄弱也是最需要重视的环节。控制好这些环节，对提高 PCR 检验的准确度、可信度，提高分子生物学诊治水平，提高检验人员的业务水平，减少医患纠纷以及对 PCR 实验室的技术准入、验收都是非常重要的，也是非常必要的。笔者从 PCR 检验申请单正确填写，患者的准备，标本的采集、处理、运送、储存、不合格标本的拒收，实验室技术人员的要求，仪器设备的校准、维护，试剂、耗材的质检，标准化操作程序（SOP）的编写和执行、实验室安全等分析前的相关环节对PCR 检验质量的影响予以阐述，供同行参考。

Polymerase Chain Reaction （PCR）in recent years is a new disease detection methods basedon molecular biology level.It has the advantage of sensitive,specific,trace,simple,fast,but in the operation due to multiple factors,quality control is not easy to control.Especially in the first stage of quality control,it engages alot of operations and is weakest stage such needs most concern.It is necessary and important to have a good quality control;it not only improve the reliability and accu-racy of PCR testing,treatment of molecular biology,the professional level of work staff,but also reduce patient disputes and increase technology access,acceptance of the PCR laboratory.In this paper,the author from the factors which influence the first stage of PCR：whether correctly fill PCR test application form,patient preparation,handling,transportation,storage of good sample,unqualified specimen rejection,the requirement of laboratory technicians,calibration and maintenance on the in-struments;quality check on reagents,consumables quality inspection,standard operating procedures （SOP）writing,and la-boratory safety.Hope this paper can do a good reference for other same profession.