摘要
目的针对胃黏膜组织标本的幽门螺杆菌(HP)感染诊断的real time-PCR检测和分离培养2种最常用方法进行结果一致性分析,为HP感染诊断方法的选择提供科学依据。方法在浙江省4个地区(萧山、温岭、苍南和湖州)各选取1所医院,采集2020年11月16日至12月7日送至杭州致远检验医学研究所进行HP分离培养和耐药性分析的全部患者胃窦部黏膜活检标本,共1312份。每份样本经研磨匀浆处理后分为2份,分别用于常规HP分离培养和real time-PCR检测(以cagH为检测靶点),2种方法平行双盲进行。检测结果的一致性及不同医院来源样本间的差异用χ^(2)检验、Fisher精确检验以及独立样本t检验等统计学方法进行分析。结果1312份样本中,分离培养法和real time-PCR法的阳性率分别为29.34%(385/1312)、28.51%(374/1312),差异无统计学意义(P=0.636)。来自4所医院的标本,2种方法的检出率差异均无统计学意义(P=0.075),二者在萧山某院、温岭某院、苍南某院、湖州某院样本以及总体样本中的Kappa值分别为0.84、0.89、0.75、0.91、0.85。real time-PCR法的灵敏度和特异度分别为89.26%、100.00%。在real time-PCR法检测阳性而培养阴性的样本中,检测Ct值为25.47~34.97,均值为30.90,90%的Ct值均≤34.46,频数最高组为29.00~30.00组。结论分离培养法和real time-PCR法在临床胃黏膜标本HP诊断中均可达到较高的检测效能,且2种方法检出结果一致性良好,可应用于HP个体化治疗,以便在做出HP感染诊断的同时提供受检者的药敏检测结果。标本中HP菌量及标本的保存运输条件可能对结果产生重要影响。
Objective To evaluate the consistency of two diagnostic methods(isolation culture and real time-PCR)that are commonly used in detection of Helicobacter pylori(H.pylori)in gastric antrum mucosal specimen.Methods Four hospitals in Xiaoshan,Wenling,Cangnan,and Huzhou in Zhejiang province were selected.From November 16,2020 to December 7,2020,a total of 1312 gastric antrum mucosal specimens were collected from the four hospitals and submitted to Zhiyuan Medical Laboratory in Hangzhou.Each specimen was processed in duplicate and subjected to H.pylori isolation and real time-PCR detection(cagH as target)in a parallel and double-blind manner.Pearson'sχ^(2) test,Fisher's exact test,McNemar's pairedχ2 test,independent-sample t-test,and other related statistical methods were used to analyze the consistency of the two methods and the differences among the four hospitals.Results The H.pylori positive rate of culture was 29.34%(385/1312)and the H.pylori positive rate of real time-PCR was 28.51%(374/1312),the difference was not significant(P=0.636).The positive rates of the two methods had no significant difference among the specimens from four hospitals respectively(P>0.05),and the Kappa values were 0.84,0.89,0.75,0.91 and 0.85 in the specimens from Xiaoshan,Wenling,Cangnan,Huzhou hospitals and in all specimens,respectively.The sensitivity and specificity of the real time-PCR were 89.26%and 100.00%.Among the real time-PCR single positive samples,the range of Ct value was from 25.47 to 34.97,with a mean value of 30.90.There were 90%Ct values no more than 34.46 and the highest frequency group was the 29.00–30.00 group.Conclusion Both the cultural and real time-PCR could achieve high detection efficacy in the detection of H.pylori in clinical gastric antrum mucosal specimen.The results of both methods had good consistency,and each single method had good reliability.The content of H.pylori in specimen and specimen transportation method might have significant effects on results.
作者
杨雅名
何利华
杨宁敏
宫雅楠
韩秀瑞
范如岳
薛志静
魏永越
张建中
Yang Yaming;He Lihua;Yang Ningmin;Gong Yanan;Han Xiurui;Fan Ruyue;Xue Zhijing;Wei Yongyue;Zhang Jianzhong(Center for Global Health,School of Public Health,Nanjing Medical University,Nanjing 211166,Jiangsu,China;State Key Laboratory of Communicable Disease Prevention and Control,Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases,National Institute for Communicable Disease Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China;Zhiyuan Inspection Medical Institute,Hangzhou 310022,Zhejiang,China;Department of Biostatistics,School of Public Health,Nanjing Medical University,Nanjing 211166,Jiangsu,China)
出处
《疾病监测》
CAS
CSCD
北大核心
2022年第5期641-645,共5页
Disease Surveillance
基金
国家科技重大专项(No.2018ZX10712–001)。
