3种新型冠状病毒核酸检测试剂对120份样本检测结果的比较与分析

目的对市售的3种国产新型冠状病毒核酸检测试剂(实时荧光RT-PCR法)的检测结果进行比较和分析,以供检测机构参考。方法采用3种核酸检测试剂(实时荧光RT-PCR法)对120份新冠肺炎病人和密切接触者的咽拭子、尿液、唾液和粪便样本进行平行检测,运用SPSS20软件采用卡方检验对检测结果进行分析。结果 120份样本中,3种试剂阳性率分别为42.50%(51/120)、39.17%(47/120)和41.67%(50/120),阳性检出率无统计学差异(χ²=0.298,P>0.05),对4种样本检测阳性检出率,差异无统计学意义(P>0.05)。3种试剂检测结果一致的有89份。检测结果一致性从高到低为:A试剂和C试剂>B试剂和C试剂>A试剂和B试剂。结论由于不同厂家试剂灵敏度和准确性不同导致检测结果和检测一致性存在差异,提示试剂厂家需进一步优化性能,提高检测灵敏度和准确性,同时各检测机构应采取多种质控方法以确保新冠病毒核酸检测准确性,以便更好地为疫情防控、病人救治提供科学依据。

Comparison and analysis of results of 120 specimens with three SARS-CoV-2 nucleic acid detection reagents

To provide reference for laboratory by comparing and analyzing the test result of three SARS-CoV-2 nucleic acid detection reagents (real-time RT-PCR).Three kinds of nucleic acid detection reagents (real-time RT-PCR) were used to parallel detect 120 Corona Virus Disease 2019(COVID-19) specimens, including swabs, urine, saliva and feces,and the results were analyzed with SPSS20. As results the positive rates for the A,B,C reagents were 42.50%(51/120), 39.17%(47/120), and 41.67%(50/120), respectively, 89 cases were shown in the same results and there was no significant difference among three reagents(χ²=0.298,P>0.05), there was no significant difference in the positive detection rate of the four types samples, also(P>0.05). The consistency of test results from high to low is: A reagent and C reagent> B reagent and C reagent> A reagent and B reagent. There are differences in the test results and test consistency between different manufacturers due to different sensitivity and accuracy. The reagent performance should be further optimized to improve detection sensitivity and accuracy should be improved. At the same time, laboratory should take various quality control methods to ensure the accuracy of SARS-CoV-2 nucleic acid detection,in order to provide better scientific basis for disease prevention and control.