基于分子检测技术的实验室质量改进与管理

临床医生获得与疾病相关的分子检测数据以及据此做出准确诊断，是后续实行精准治疗的前提和基础。分子检测结果的准确与否不仅要依靠先进检测设备和检测技术，还要高度重视实验室管理和数据的质量控制。高质量的分子检测数据是包括技术人员的综合专业素质、实验操作流程的规范性、实验室内部质量管理等方面集中反映。正确处置这些要素对检测结果的准确性和可重复性起着重要作用。本文就核酸分子检测中常用的突变扩增阻滞系统(amplification refractory mutation system，ARMS)技术结合实时荧光定量PCR(ARMS-PCR)检测技术和二代测序技术在应用过程中出现的问题进行分析和讨论，旨在与业内人士一起学习交流，以提高检测结果的可靠性，为临床提供可靠的实验室诊疗依据。

Improvement in quality control and laboratory management for molecular test platform

The data derived from molecular test and analysis of a person′s genetic makeup, or the genetic profile of individual′s tumor are the basis for clinic physician to proceed with precision medicine accordingly. However, to obtain accurate molecular data, it is not only relied on the advanced equipment and methods, but also requires the appropriate procedures for laboratory management and quality control. Under these circumstance, a laboratory technician with appropriate certification should be equipped with professional skills/knowledge and perform the test by following the standard of experimental procedures strictly, and then high quality data should be obtained. Thus, both complying systematically standard operating procedure and meanwhile paying serious attention to each step are critical for the accuracy and repeatability of test results. In this paper, we discussed the issues occurred in the laboratory when next generation sequencing and ARMS-PCR were conducted to draw everyone′s attention and in return to improve the quality of performance for reliable results.