基于危害分析及关键控制点体系的核酸检测实验室质量控制研究

Research on quality control of nucleic acid testing laboratory based on HACCP system

目的通过危害分析及关键控制点(hazard analysis and critical control point,HACCP)体系系统化控制核酸检测实验室质量,以期能够实现核酸检测实验室质量的提升,为有效制定核酸检测质量控制对策提供借鉴。方法根据HACCP体系初步探究核酸检测实验室质量控制,重点分析HACCP体系在核酸标本接收、准备试剂、提取标本核酸、核酸扩增、结果判读、核酸检测结果报告环节制定的监控程序、验证措施以及纠偏措施等重要控制点。结果通过分析2021年12月-2022年12月的检测数据,结果显示,各批次核酸检测阳性质控品均满足判定规则,每一批次的实验均处于在控状态。对HACCP体系下实验室数据进行统计,计算其标准差、均值以及变异系数,对箱型图绘制后,展开离群值检验,结果发现,均值没有产生离群值。结论核酸检测实验室中应用HACCP体系,能够有效控制核酸检测实验室质量,全面掌控核酸检测实验室重要控制点,实现实验室生物安全水平与质量的提升,保证核酸检测实验室质控的有效性与科学性,继而有效控制核酸检测实验室质量。

Objective To systematically control the quality of nucleic acid testing laboratories through the HACCP system,in order to improve the quality of nucleic acid testing laboratories and provide reference for effectively formulating quality control strategies for nucleic acid testing.Methods Preliminary exploration of quality control in nucleic acid testing laboratories based on the HACCP system,with a focus on analyzing the monitoring procedures,validation measures,and corrective measures developed by the HACCP system in the stages of nucleic acid sample reception,preparation of reagents,sample nucleic acid extraction,nucleic acid amplification,result interpretation,and nucleic acid testing result reporting.Results By analyzing the testing data December 2021 to December 2022,the results showed that all batches of nucleic acid positive quality control products met the judgment rules,and each batch of experiments was in a controlled state.Statistical analysis was conducted on laboratory data under the HACCP system,calculating their standard deviation,mean,and coefficient of variation.After plotting the box plot,outlier tests were conducted,and it was found that the mean did not produce outliers.Conclusion The application of HACCP system in nucleic acid testing laboratories can effectively control the quality of nucleic acid testing laboratories,comprehensively control important control points of nucleic acid testing laboratories,improve the level and quality of laboratory biosafety,ensure the effectiveness and scientificity of quality control in nucleic acid testing laboratories,and then effectively control the quality of nucleic acid testing laboratories.