新型冠状病毒核酸检测的质量控制分析

Quality control analysis for SARS-CoV-2

目的严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)核酸检测为COVID-19确诊的主要方法。SARS-CoV-2核酸检测阳性率低、检测结果与临床诊断不吻合等问题备受关注。方法通过查阅COVID-19相关诊疗方案、专家共识与相关文献,结合甘肃省人民医院国家卫生健康委员会胃肠肿瘤诊治重点实验室核酸检测的经验,从分析前、分析中以及分析后详细阐述SARS-CoV-2核酸检测中质量控制的关键点与现存问题。结果多方面因素影响SARS-CoV-2核酸检测质量,但分析前质量控制中的样本采集、样本运输、检测试剂盒与人员培训等是主要影响因素。结论综合因素导致SARS-CoV-2核酸检测存在漏检、假阴性与阳性率低的情况。

Objective The nucleic acid test of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)is the main standard for the diagnosis of Corona Virus Disease 2019(COVID-19).Recently,SARS-CoV-2 nucleic acid detection has resulted in a low positive rate and the inconsistency between the test results and clinical diagnosis has attracted much attention.Methods The key points of quality control and existing problems before,during and after analysis in nucleic acid detection of SARS-CoV-2 were described in detail.Results Factors affecting the quality of SARS-CoV-2 nucleic acid detection were various,mainly involved in sample collection,sample transportation,personnel training and testing kit.Conclusion The false negative results in the detection of SARS-CoV-2 were caused by different factors.The detailed discussion could be useful for reference to the colleagues all over the country as well as provide theoretical help for the development of nucleic acid detection in prefectural and county-level hospitals.