2种实时荧光定量聚合酶链式反应法检测HBeAg阳性慢性乙型肝炎患者血清HBV RNA的一致性分析  

Comparison of two quantitative real-time PCR methods for serum HBV RNA in patients with HBeAg-positive chronic hepatitis B:A propensity score matching study

作　　者：王扬[1] 廖昊 邓中平 卞丹丹 任艳[1] 蒋莹莹[1] 刘霜[1] 陈煜[1] 鲁凤民[2] 段钟平[1] 郑素军[1] WANG Yang;LIAO Hao;DENG Zhongping;BIAN Dandan;REN Yan;JIANG Yingying;LIU Shuang;CHEN Yu;LU Fengmin;DUAN Zhongping;ZHENG Sujun(Difficult&Complicated Liver Diseases and Artificial Liver Center,Beijing YouAn Hospital,Capital Medical University,Beijing 100069,China;Department of Microbiology and Infectious Disease Center,School of Basic Medical Sciences,Peking University Health Science Center,Beijing 100191,China;Academy for Advanced Interdisciplinary Studies,Peking University,Beijing 100871,China;Hunan Provincial Key Laboratory of Gene Diagnostic Technology,Changsha 410205,China;Department of Infectious Diseases,Electric Power Teaching Hospital,Capital Medical University,Beijing 100073,China)

机构地区：[1]首都医科大学附属北京佑安医院疑难肝病与人工肝中心,北京100069 [2]北京大学基础医学院病原生物学系暨感染病中心,北京100191 [3]北京大学前沿交叉学科研究院,北京100871 [4]基因诊断技术湖南省重点实验室,长沙410205 [5]首都医科大学电力教学医院感染性疾病科,北京100073

出　　处：《临床肝胆病杂志》2022年第5期1035-1040,共6页Journal of Clinical Hepatology

基　　金：国家科技重大专项“艾滋病和病毒性肝炎等重大传染病防治”(2017ZX10302201-004,2017ZX10202203-006,2017ZX10201201,2017ZX10203201-005)。

摘　　要：目的评价S(Shengxiang)公司、X(Xinbo)公司两种实时荧光定量聚合酶链式反应(real-time PCR)方法定量检测HBV RNA结果的一致性。方法从2007年7月—2008年8月组建的108例慢性乙型肝炎(CHB)前瞻性随访患者队列中,选取HBeAg血清学转换患者20例进行1∶1倾向性评分匹配未转换患者20例,采用S公司和X公司两种real-time PCR定量检测方法,回顾性检测基线、12周、24周及48周血清样本HBV RNA。符合正态分布的计量资料组间比较采用配对t检验;不符合正态分布的计量资料组间比较采用Mann-Whitney U检验。计数资料采用χ^(2)检验。通过Pearson相关系数、组内相关系数(ICC)和Bland-Altman法评价检测结果的一致性。结果S试剂检测132份血清样本,X试剂检测154份血清样本,两种试剂对送检样本中HBV RNA检出率均为100%。两种试剂共同检测血清样本131份,在基线、随访12周、24周及48周分别检测34、29、35及33份血清,X试剂检测HBV RNA定量数据分别为(5.75±1.64、5.43±1.73、5.13±1.54、4.76±1.55)log_(10)拷贝/mL,均高于S试剂(4.80±1.48、4.52±1.53、4.10±1.50、3.92±1.43)log_(10)拷贝/mL,差异均有统计学意义(t=8.348、t=5.341、Z=-5.086、Z=-4.762,P值均<0.001)。两种方法相关性分析中,r及ICC值分别为0.915(95%CI:0.836~0.957)与0.771(95%CI:-0.021~0.931)、0.849(95%CI:0.701~0.927)与0.733(95%CI:0.138~0.902)、0.951(95%CI:0.905~0.975)与0.776(95%CI:-0.058~0.942)、0.933(95%CI:0.867~0.967)与0.804(95%CI:-0.014~0.944)(P值均<0.05)。Bland-Altman分析表明,两种方法检测结果中96.18%(126/131)的样本差异位于平均差±1.96标准差之间。结论X试剂的HBV RNA定量结果高于S试剂定量结果,但两种real-time PCR定量检测HBeAg血清学转换和未转换CHB患者HBV RNA结果的一致性良好。Objective To investigate the consistency between Shengxiang(S)and Xinbo(X)real-time PCR methods in the quantification of HBV RNA.Methods In the prospective follow-up cohort of 108 chronic hepatitis B(CHB)patients established from July 2007 to August 2008,20 patients with HBeAg seroconversion were selected,and 20 patients without seroconversion were selected by propensity score matching at a ratio of 1∶1.The two quantification methods from S and X companies were used,and a retrospective analysis was performed for HBV RNA in serum samples at baseline and weeks 12,24,and 48.The paired t-test was used for comparison of normally distributed continuous data between groups,and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups;the chi-square test was used for comparison of categorical data.The Pearson correlation coefficient,intraclass correlation coefficient(ICC),and the Bland-Altman method were used to evaluate the consistency of the two quantification methods.Results A total of 132 serum samples were tested by S reagent,and 154 were tested by X reagent;the detection rate of HBV RNA was 100%by both reagents.A total of 131 serum samples were tested by both reagents,with 34 samples at baseline and 29,35,and 33 samples,respectively,at weeks 12,24,and 48 of follow-up;at these four time points,the HBV RNA quantification data detected by X reagent were significantly higher than those detected by S reagent(5.75±1.64/5.43±1.73/5.13±1.54/4.76±1.55 log_(10) copies/mL vs 4.80±1.48/4.52±1.53/4.10±1.50/3.92±1.43 log_(10) copies/mL,t=8.348,t=5.341,Z=-5.086,Z=-4.762,all P<0.001).The correlation analysis of the two methods showed a Pearson correlation coefficient of 0.915(95%confidence interval[CI]:0.836-0.957)and an ICC of 0.771(95%CI:-0.021 to 0.931)at baseline,a Pearson correlation coefficient of 0.849(95%CI:0.701-0.927)and an ICC of 0.733(95%CI:0.138-0.902)at week 12,a Pearson correlation coefficient of 0.951(95%CI:0.905-0.975)and an ICC of 0.776(95%CI:-0.058 to 0.

关 键 词：乙型肝炎 慢性 RNA 聚合酶链反应 

分 类 号：R51[医药卫生—内科学]