两种新冠病毒核酸检测系统检测结果的比对分析

目的 对不同新型冠状病毒(SARS-CoV-2)核酸检测方法进行比较和分析,探讨核酸提取扩增检测一体化的实时荧光定量PCR系统的应用价值。方法 2020年1月—10月于新型冠状病毒肺炎(coronavirus disease 2019,COVID-19)复核样本库中随机抽取确诊病例和排除病例的灭活咽拭子标本,共计10份。采用盲法随机编号,同时使用全自动医用PCR分析系统GeneXpert DX system和ABI QuantStudio Dx实时定量PCR检测系统进行检测,每组均进行平行检测,利用四格表法对结果进行一致性分析。结果 检测结束后揭盲,所有样本纳入统计分析,无剔除数据。经检测,两种方法对8例新冠病毒确诊病例咽拭子检测结果均为阳性,2例排除病例咽拭子检测结果均为阴性;两种方法检测结果一致性好(Kappa系数=1,P值=0.002);使用方法A检测前处理时间为30秒,结果报告时间为48分钟;在核酸检测过程中检测人员与样本接触时间短,气溶胶危险较低,试剂盒全程密封,实验完成后标本处理安全性高。结论 方法A与方法B在新型冠状病毒核酸检测中结果一致,方法A具备操作环节简单、生物安全风险系数小、检测更为快速等优点。

Comparative analysis of the detection results of two new coronavirus nucleic acid detection systems

Objective To compare and analyze the detection results of different SARS-CoV-2 nucleic acid detection methods, and to explore the clinical application value of the real-time fluorescence PCR instrument integrating nucleic acid extraction, amplification and detection. Methods From January to October 2020, randomly select 10 inactivated novel coronavirus throat swab samples from the new coronavirus pneumonia review sample library . Used the automatic medical PCR analysis system GeneXpert DX system instrument and corresponding detection reagent A and ABI QuantStudio Dx real-time quantitative PCR instrument and reagent B for detection. Each group was tested in parallel, Used the four-grid table method to analyze the consistency of the results. Results Unblinded after the test, all samples were included in statistical analysis, no data was excluded. The two methods tested positive for the throat swabs of 8 confirmed cases of the new coronavirus, and the throat swabs of the 2 excluded cases were negative. The test results of the two methods were in good agreement (Kappa coefficient=1, P value=0.002). Using method A, the pre-processing time was 30 seconds, and the result reporting time was 48 minutes. When using reagent A, the contact time between the tester and the sample during the nucleic acid detection was short, and the aerosol risk was low, the kit was sealed in the whole process, and the specimen processing safety was higher. Conclusion Method A and method B had the same results in the new coronavirus nucleic acid test, method A had advantages of simpler operation, less risk factor of biosafety and faster result issuance.