摘要
目的分析国产高敏HCV-RNA核酸检测试剂与国产普敏、进口高敏HCV-RNA核酸检测试剂的一致性。方法选取2021年1月至9月中国科学技术大学附属第一医院感染病医院检验科收录的丙肝患者临床样本165例,分别采用国产高敏HCV-RNA核酸检测试剂A与国产普敏HCV-RNA核酸检测试剂B进行HCV-RNA定量检测,对两种HCV-RNA定量检测试剂定量结果均为阳性的样本(≥500 IU/mL,87例)进行Bland-Altman一致性分析;选择稀释样本(15~500 IU/mL,60例),采用国产高敏HCV-RNA核酸检测试剂A与进口高敏HCV-RNA核酸检测试剂C进行HCV-RNA平行定量检测,对两种HCV-RNA定量检测试剂定量结果进行Bland-Altman一致性分析。结果Bland-Altman分析显示试剂A与试剂B定量值差值均值为(-0.0326)log_(10)IU/mL,95%置信区间为(-0.4626~0.3974)log_(10)IU/mL,95.4%(83/87)的样本检测值在95%置信区间内。试剂A与试剂C定量值差值均值为0.1800 log_(10)IU/mL,95%可信区间为(-0.0907~0.4506)log_(10)IU/mL,96.67%(58/60)的样本检测值在95%置信区间内。结论国产高敏定量试剂A与国产普敏定量试剂B在≥500 IU/mL检测结果具有一致性,国产高敏定量试剂A与进口高敏定量试剂C在15~500 IU/mL具有检测结果高度一致性。
Objective To analyze the consistency among domestic high-sensitivity HCV-RNA nucleic acid detection reagents,domestic low-sensitivity HCV-RNA nucleic acid detection reagents and imported high-sensitivity HCV-RNA nucleic acid detection reagents.Methods 165 HCV patients’clinical samples from the Laboratory Department of The First Affiliated Hospital of USTC Infectious Disease Hospital were selectde.These samples were collected from January to September 2021.The domestic high-sensitivity HCV-RNA nucleic acid detection reagent A and the domestic low-sensitivity HCV-RNA nucleic acid detection reagent B were respectively used for quantitative detection of HCV-RNA.Samples with positive quantification results for both HCV-RNA quantification reagents(≥500 IU/mL,87samples),used the Bland-Altman method to consistency analysis;selected dilution samples(15-500 IU/mL,60 samples),used the domestic high-sensitivity HCVRNA nucleic acid detection reagent A and imported high-sensitivity HCV-RNA nucleic acid detection reagent C to parallel quantitative detection of HCV-RNA,used the Bland-Altman method to consistency analysis those quantitative results of two HCV-RNA quantitative detection reagents.Results Bland-Altman analysis showed that the mean difference between the quantitative values of reagent A and reagent B was(-0.0326)log_(10)IU/m L,95%CI was(-0.4626-0.3974)log_(10)IU/m L,95.4%(83/87)of samples detected values within the 95%CI.The mean difference between the quantitative values of reagent A and reagent C was 0.1800 log_(10)IU/m L,95%CI was(-0.0907-0.4506)log_(10)IU/m L,96.67%(58/60)of samples detected values within the 95%CI.Conclusion The detection results of domestic high-sensitivity quantitative reagent A and domestic low-sensitivity quantitative reagent B were consistent at≥500 IU/mL,while domestic high-sensitivity quantitative reagent A and imported high-sensitivity quantitative reagent C had high consistency in detection results at 15-500 IU/mL.
作者
刘婷
武建明
姚亮
佟艳会
戚应杰
LIU Ting;WU Jianming;YAO Liang;TONG Yanhui;QI Yingjie(The First Affiliated Hospital of University of Science and Technology of China(Anhui provincial hospital infection hospital),Hefei,230000,Anhui,China;Geneway Biotechnology Co.,Ltd.Jinan,250100,Shandong,China)
出处
《大医生》
2023年第4期1-6,共6页
Doctor
基金
国家十三五“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项(编号:2018ZX10722-301-003-001)。
关键词
体外诊断试剂
高敏HCV-RNA荧光定量PCR
对比分析
In vitro diagnostic reagent
High sensitivity fluorescence quantification PCR of HCV-RNA
Bland-altman analysis
