传染病示范区基层医疗机构HBV血清学标志物检测准确率调查  

Survey on the testing accuracy of HBV serological markers among grassroots medical institutions in the demonstration areas of infectious diseases

作　　者：丁丞[1] 黄晨阳 陈灿 周雨晴 严丹莹 刘晓晓 傅晓芳 蓝蕾 杨仕贵[1] Ding Cheng;Huang Chenyang;Chen Can;Zhou Yuqing;Yan Danying;Liu Xiaoxiao;Fu Xiaofang;Lan Lei;Yang Shigui(State Key Laboratory for Diagnosis and Treatment of Infectious Diseases,National Clinical Research Center for Infectious Diseases,Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases,the First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310003,China)

机构地区：[1]浙江大学医学院附属第一医院传染病诊治国家重点实验室,国家感染性疾病临床医学研究中心,感染性疾病诊治协同创新中心,杭州310003

出　　处：《中华临床感染病杂志》2021年第4期266-271,共6页Chinese Journal of Clinical Infectious Diseases

基　　金："艾滋病和病毒性肝炎等重大传染病防治"科技重大专项(2018ZX10715014,2013ZX10004904)。

摘　　要：目的分析传染病示范区基层医疗机构HBV血清学标志物检测的准确性,为准确评估示范区乙型肝炎流行水平提供参考。方法在全国6个乙型肝炎示范区内,定额抽取乙型肝炎普通人群观察队列并采集相应的血标本,由基层医疗机构进行检测HBsAg和抗-HBs,同时送第三方平台进行检测,分析两组检测结果的差异性和一致性。采用SAS 9.4软件对数据进行分析。结果HBsAg指标检测5756份,抗-HBs指标检测5263份。基层医疗机构HBsAg和抗-HBs指标的检测结果与第三方平台检测结果对比,HBsAg指标符合率为97.13%,抗-HBs指标符合率为77.33%。HBsAg和抗-HBs指标的Kappa值分别为0.56(95%CI 0.50~0.62)和0.54(95%CI 0.52~0.56),McNemar检验提示差异均具有统计学意义(P值均<0.01)。各示范区检测结果与第三方结果比较,差异具有统计学意义(P<0.05或<0.01),江苏和广东示范区HBsAg指标一致率较高(Kappa值分别为0.87和0.81),甘肃和广东示范区抗-HBs指标一致率较高(Kappa值均为0.74)。以第三方平台检测结果作为参照,基层医疗机构检测HBsAg的敏感度为40.51%,特异度为99.96%;抗-HBs的敏感度为73.18%,特异度为84.31%。广东和江苏示范区HBsAg指标鉴别能力较高(约登指数分别为0.69和0.80),甘肃和广东示范区抗-HBs指标鉴别能力较高(约登指数分别为0.78和0.76)。结论乙型肝炎示范区基层医疗机构HBV血清学标志物检测结果与第三平台检测结果之间存在一定差异。基层医疗机构当前的检测手段适用于排除HBV感染者,检测实施过程中假阴性的情况需要加以关注。Objective To evaluate the detection accuracy of hepatitis B virus(HBV)serological markers among grassroots medical institutions in the demonstration areas of infectious diseases.Methods A fixed sampling method was used among the followed-up hepatitis B cohort in general population of six infectious disease demonstration areas nationwide.Blood samples of chosen objects were collected,in which HBsAg and anti-HBs were tested by grassroots medical institutions and were also parallely tested by the third-party platform.The test results were compared between the two groups.Statistical analyses were conducted by SAS 9.4 software.Results A total of 5756 and 5263 samples of HBsAg and anti-HBs were successfully tested,respectively.Comparing the results of HBsAg and anti-HBs from grassroots medical institutions with the results from the third platform,the agreement of HBsAg and anti-HBs was 97.13%and 77.33%,respectively.The Kappa value was 0.56(95%CI 0.50-0.62)for HBsAg and 0.54(95%CI 0.52-0.56)for anti-HBs,respectively;and the McNemar tests indicated the difference between the results(all P<0.01).There were also significant differences in agreement of testing results with the third platformin among different regions(P<0.05 or<0.01).The Kappa values indicated that Jiangsu province and Guangdong province had high accordance rates of HBsAg(0.87 and 0.81,respectively),and Gansu province and Guangdong province had high accordance rates of anti-HBs(Both were 0.74).Regarding the results from the third platform as the standard,the sensitivity of HBsAg testing in grassroots medical institutions was moderate(40.51%)and the specificity was well(99.96%).The sensitivity of anti-HBs testing was substantial(73.18%)and the specificity was well(84.31%).Guangdong province(Youden index:0.69)and Jiangsu province(Youden index:0.80)had high identification ability for HBsAg,and for indicator of anti-HBs,Gansu province(Youden index:0.78)and Guangdong province(Youden index:0.76)had high identification ability.Conclusion There are certain differenc

关 键 词：肝炎病毒 乙型 肝炎表面抗原 乙型 肝炎表面抗体 乙型 基层医疗机构 准确率 

分 类 号：R512.62[医药卫生—内科学] R446.1[医药卫生—临床医学]