质控图在实时荧光定量PCR定性检测实验室质控中的应用  

Application of quality control chart to internal quality control of qualitative detection by real-time PCR

作　　者：曹颜霞 李艳红 郭丽群 马伟华 刘贤段 周晗 刘斐 张晴 任晓雨 张金男 CAO Yan-xia;LI Yan-hong;GUO Li-qun;MA Wei-hua;LIU Xian-duan;ZHOU Han;LIU Fei;ZHANG Qing;REN Xiao-yu;ZHANG Jin-nan(Laboratory Department,Zhoucun District Center for Disease Prevention and Control,Zibo City,Shandong 255300,China)

机构地区：[1]淄博市周村区疾病预防控制中心检验科,山东255300

出　　处：《预防医学论坛》2024年第10期792-795,共4页Preventive Medicine Tribune

摘　　要：目的以循环数阈值(CT值)作为检测值绘制质控图,探讨质控图作为实时荧光定量聚合酶链式反应(PCR)定性检测室内质控措施的可行性。方法收集本实验室2022年12月-2023年3月所有批次新型冠状病毒样本,对样本采用实时荧光定量PCR方法进行新型冠状病毒检测,对弱阳性质控品结果的两组靶基因CT值进行正态分布检验。统计前20次质控结果,分别计算开放读码框1ab(ORF1ab)基因和核壳蛋白(N)基因两组CT值的均值(x±s)、标准差(s)。以x±2s为警告线,x±3s为控制线,绘制质控图,并利用质控图进行回顾性分析。结果弱阳性质控品ORF1ab基因和N基因的CT值均符合正态分布。质控图表明118批次质控结果中,ORF1ab基因出现8次13s失控;N基因出现6次13s失控、1次10x失控。结论在实时荧光定量PCR定性检测过程中,应用质控图进行室内质控具有可行性,能够有效监控检测过程中的异常情况,有利于检测系统处于持续稳定状态。Objective To explore the feasibility of the quality control chart used as an internal quality control method of nucleic acid qualitative detection by real-time PCR and the control chart used cycle threshold(CT)as test values.Methods All batches of SARS-CoV-2 samples from the laboratory between December 2022 and March 2023 were collected,and the samples were tested for SARS-CoV-2 using real-time fluorescent quantitative PCR.A normal distribution test was conducted on the CT values of the 2 target genes in the results of the weak positive quality control samples.According to the first 20 tests,the mean value(x),standard deviation(s)and coefficient of variation(CV)of ORF1ab gene CT values and N gene CT values were calculated respectively and the quality control charts were plotted.The control chart was drawn with“x±2s”warning limit,“x±3s”control limit and was used to analyze the positive quality control results retrospectively.Results The CT values of ORF1ab gene and N gene fitted a normal distribution.The quality control results of 118 batch tests were plotted with“1_(3s)”out of control for 8 times in ORF1ab gene chart and with“1_(3s)”out of control for 6 times,“10x”out of control for 1 time in N gene chart.Conclusion The application of the control chart to internal quality control is feasible in the process of nucleic acid qualitative detection by real-time PCR and could effectively monitor the abnormal accidents in the tests and is helpful for the test system in a continuous stability.

关 键 词：质控图 室内质控 实时荧光定量 实验室检测 

分 类 号：R115[医药卫生—公共卫生与预防医学]