3种实时荧光PCR仪对120份新型冠状病毒检测标本的检测结果比较

Comparison and analysis on 120 specimens for SARS-CoV-2 detection resultswith three different fluorescent quantitative PCR instruments

目的对不同厂家生产的3种实时荧光PCR仪检测的同一批新型冠状病毒检测标本结果进行比较分析,考察3种实时荧光PCR仪对新型冠状病毒核酸检测结果的差异。方法采用同一厂家同一批号新型冠状病毒核酸检测试剂,运用3种不同型号实时荧光PCR仪对120例新型冠状病毒肺炎患者及密切接触者的咽拭子、尿液、唾液、粪便标本进行检测,采用SPSS20.0统计软件对检测结果和检测一致性进行分析。结果3种仪器检出率分别为42.50%、35.00%、38.33%。有95例患者标本通过3种仪器扩增后检测结果一致。以仪器A检测结果为参照,仪器B有21例检测结果不同,两者检出率差异无统计学意义(P>0.05),检测结果一致性一般(K=0.732);仪器C有14例检测结果不同,两者检出率差异无统计学意义(P>0.05),检测结果一致性好(K=0.821)。结论由于不同厂家生产的仪器原理和仪器使用维护状况不同导致检测结果存在一定差异,提示仪器厂家需进一步优化仪器性能,提高检测准确性;同时各检测机构应按照要求对PCR仪进行校准维护,确保仪器状态正常,并尽可能采取多种质控手段以确保检测结果准确性。

Objective To compare and analyze the result of same samples detected SARS-CoV-2 by three different fluorescent quantitative PCR instruments,and to investigate the differences of instrument factor on detection of SARS-CoV-2,in order to provide reference for laboratory.Methods Three kinds of real-time fluorescent PCR instruments were used to parallel detect 120 specimens,including oropharyngeal swabs,urine,saliva and feces,and the results were analyzed with SPSS20.0.Results The positive detection rates of the three instruments were 42.50%,35.00%and 38.33%.The results of 95 samples detected by three instruments were consistent.Taking the results of instrument A as a reference,21 samples of instrument B showed different results,and there was no significant difference on the positive detection rate between them(P>0.05),and the test results were generally consistent(K=0.732).A total of 14 samples of instrument C had different test results with instrument A,and there was no significant difference on the positive detection rate between them(P>0.05),and the test results had better consistency(K=0.821).Conclusion Due to the different principle of the instrument and the different use conditions of the three instruments,there are differences results.It is suggested that the instrument manufacturers should further optimize the instrument performance and improve the accuracy of the test.At the same time,laboratory should calibrate and maintain the PCR instruments according to the requirements to ensure the instrument status and take different quality control measures to ensure that accuracy of test results.