15种新型冠状病毒核酸检测试剂的检测性能比较  

Comparison of detection performance of 15 Novel Coronavirus nucleic acid testing reagents

作　　者：黄忠平 杨慧萍[1] 冯玉亮 徐朝花 马小珍[1] HUANG Zhong-ping;YANG Hui-ping;FENG Yu-liang;XU Chao-hua;MA Xiao-zhen(Sichuan Center for Disease Control and Prevention,Chengdu 610041,Sichuan Province,China.)

机构地区：[1]四川省疾病预防控制中心,成都610041

出　　处：《职业卫生与病伤》2023年第1期60-64,共5页Occupational Health and Damage

基　　金：四川省医学科技项目(项目编号:22ZDCX002)。

摘　　要：目的 比较15种新型冠状病毒(COVID-2019)核酸检测试剂的阳性率,为新冠核酸检测实验室选择检测试剂提供参考。方法 挑选2021—2022年四川新型冠状病毒阳性样本50份,选取15种新型冠状病毒核酸检测试剂(编号A~O),严格按照试剂说明书进行核酸检测,运用SPSS 22.0软件对实验结果进行卡方检验。评价15种试剂检测新型冠状病毒核酸阳性率和阴性率的差异是否具有统计学意义,检验水准α=0.05。结果 15种试剂的阳性检出率分别为试剂A 18.00%、试剂B 30.00%、试剂C 60.00%、试剂D 62.00%、试剂E 56.00%、试剂F 46.00%、试剂G 62.00%、试剂H 56.00%、试剂I50.00%、试剂J 30.00%、试剂K 54.00%、试剂L 60.00%、试剂M 32.00%、试剂N 68.00%和试剂O 40.00%,其中试剂N检出率最高(68.00%),差异具有统计学意义(χ^(2)=62.464,P<0.001);试剂检测限试剂阳性率比较差异无统计学意义(χ^(2)=7.808,P=0.099);模板占体系比例20.00%~62.50%对试剂阳性率的影响具有统计学意义(χ^(2)=19.043,P=0.002),其中模板占体系比例为33.33%阳性率最高(68.00%)。结论 15种试剂对低病毒载量样本的检测,N试剂阳性率检测性能最优,也有待提升。试剂H、K需改进对内参的检测。优化试剂模板占体系比例,改进对内参的检测,提升对低病毒载量样本阳性检出率,对新冠防控有重大意义。Objective To compare the positive rates of 15 Novel Coronavirus (COVID-2019) nucleic acid testing reagents,and to provide reference for the selection of detection reagents for COVID-19nucleic acid testing laboratories.Methods Fifty COVID-2019 positive samples were selected in Sichuan Province from 2021 to 2022,and tested by 15 COVID-2019 nucleic acid detection reagents(no.A-O) strictly in accordance with the reagent instructions.Chi-square test was performed on the experimental results by SPSS 22.0 software.Whether the differences in positive rates and negative rates of the 15 reagents for COVID-2019 nucleic acid detection were statistically significant was evaluated.And the test level was α=0.05.Results The positive detection rates of 15 reagents were18.00%for reagent A,30.00%for reagent B,60.00%for reagent C,62.00%for reagent D,56.00%for reagent E,46.00%for reagent F,62.00%for reagent G,56.00%for reagent H,50.00%for reagent I,30.00%for reagent J,54.00%for reagent K,60.00%for reagent L,32.00%for reagent M,68.00%for reagent N and 40.00%for reagent O,respectively.The rates were statistically significant(χ^(2)=62.464,P<0.001).The positive rate of reagent N was the highest (68.00%).There was no significant difference in the positive rate among different detection limits(χ^(2)=7.808,P=0.099).The proportion of template in the system of 20.00%~62.50%had a statistically significant effect on the positive rate of reagent(χ^(2)=19.043,P=0.002).And the proportion of template in the system of 33.33%had the highest positive rate (68.00%).Conclusions Among the15 reagents,reagent N had the best performance in positive detection rate for low viral load samples,which also needs to be improved.Reagents H and K need to improve the detection of internal reference.It is of great significance for the prevention and control of COVID-19 to optimize the proportion of reagent templates in the system,improve the detection of internal reference,and increase the positive detection rate of samples with low viral load.

关 键 词：新型冠状病毒 核酸检测试剂 荧光PCR 阳性率 

分 类 号：R446[医药卫生—诊断学]