聚合酶链反应核酸扩增类体外诊断试剂的体系设置要求

The system setting for diagnostic reagents of polymerase chain reaction nucleic acid amplification

随着聚合酶链反应（PCR）技术的发展，PCR核酸扩增类体外诊断试剂在临床应用中的地位越来越重要。由于检测目标的复杂性以及临床对测量线性、准确度、分析特异性、亚型检测能力、精密度、检测限／定量限和干扰物质等要求，针对PCR扩增类试剂有严格的控制体系。国际学术界为了确保定量PCR实验数据的质量，已有关于实时定量PCR实验需要满足的最低要求试验信息量（MIQE）等标准，对样本处理、实验设计、体系设置及质量控制等提出了明确的要求。但在核酸扩增类体外诊断试剂的应用中，对体系设置的要求尚有很多不明确之处。本文针对PCR扩增类检测试剂在开发、生产及使用中的规范要求，依次对PCR体系设置、质量控制体系建立、核酸提取和纯化的方法学要求等进行了归纳与分析，以推动相关设计与检测标准的建立。

Diagnostic reagents of polymerase chain reaction （PCR） nucleic acid amplification is growing more and more important in the field of clinical diagnosis along with the development of the PCR technology. During to the complexity of the detection target and the clinical requirements for measuring linearity, accuracy, specificity, subtype detection, precision, limit of detection/quantification and interfering substance, the diagnostic reagents of nucleic acid amplification have a very strict control system. In order to ensure the quality of the experimental data of quantitative PCR, there have been standards such as The Minimum Information for Publication of Quantitative Real-Time PCR Experiments （ MIQE）, aiming to putting forward specific requirements for sample processing, experimental designing, system setting and quality control. But in the clinical application of nucleic acid amplification products, lots of requirements are not clear for the PCR system setup. This article discussed the requirements of PCR system setting, quality control system and Methodology of nucleic acid extraction and purification, aiming to promote the related desizn and the establishment of the standards of relevant.