两种方法检测幽门螺旋杆菌抗体及其分型的比较  

Comparison of two methods for detecting helicobacter pylori antibody and its classification

作　　者：杨燕[1] 单万水[1] 韩红星[1] 李小勇[1] 罗莎莎[1] 

机构地区：[1]深圳市第三人民医院检验科,广东深圳518000

出　　处：《中国医药科学》2013年第9期122-123,131,共3页China Medicine And Pharmacy

摘　　要：目的为考核南京大渊生物技术工程有限责任公司生产的蛋白芯片法检测幽门螺杆菌(Hp)抗体及其分型试剂的敏感性和特异性,从而判断其在临床诊断中的应用价值。方法临床上采用经SFDA注册的深圳市伯劳特生物制品有限公司的幽门螺杆菌抗体分型检测试剂盒(免疫印迹法)检测幽门螺杆菌抗体及其分型(分为CagA、VacA和Urease),共检测血清476份,检测结果与对比试剂不同的标本用第三方经SFDA认证的试剂进行复核,对于Urease不符合的病例,采用北京康美天鸿生物科技有限公司的幽门螺杆菌尿素酶抗体检测试剂盒(胶体金法)进行检测,对于CagA和VacA不一致的标本,则采用上海研域生物科技有限公司提供的ELISA试剂盒进行检测。结果南京大渊生物技术工程有限责任公司生产的蛋白芯片法检测幽门螺杆菌抗体及其分型试剂CagA阳性符合率94.5%,阴性符合率96.5%,总符合率95.8%(P>0.05);Urease阳性符合率95.1%,阴性符合率92.7%,总符合率95.4%(P>0.05);VacA阳性符合率91.6%,阴性符合率97.1%,总符合率95.2%(P>0.05);两种方法结果经统计学检验差异无统计学意义。结论经以上结果的分析,本次临床试验的有效病例476例,大渊Hp分型检测试剂盒(蛋白芯片法)与伯劳特幽门螺杆菌抗体分型检测试剂盒(免疫印迹法)的一致率均在90%以上,产品质量达到临床使用要求。Objective To inspect the protein chip method produced by Nanjing Dayuan Biotechnology Engineering Co., LTD for detection of Helicobacter pylori（Hp） antibody as well as the sensitivity and specificity of its classification reagents, so as to determine its application value in the clinical diagnosis. Methods Clinically,the helicobacter pylori antibody classification detection kit（Western blot method） produced by SFDA registration of Shenzhen Bolaote Biological Products Co., LTD was used for detection of helicobacter pylori antibody and its classification（classified into CagA,VacA and Urease）,where a total of 476 cases of serum were detected,and the specimens of test results different from the control agents were reviewed by the reagents with SFDA certification of third party; for the cases not in conformity with Urease,the helicobacter pylori urease antibody detection kit （colloidal gold method） produced by Beijing Kangmei Tianhong Btotechnology Co., LTD was used for testing; and for the specimens of CagA inconsistent with VacA,the ELISA kit provided by Shanghai Yanyu Biotechnology Co., LTD was used for testing. Results The protein chip method produced by Nanjing Daynan Biotechnology Engineering Co., LTD was used for detection of I-Ielicobacter pylori antibody and its classification reagents, where CagA positive coincidence rate was 94.5%,negative coincidence rate was 96.5%, with a total coincidence rate of 95.8% （by the chi-square test, P 〉 0.05 ）; Urease positive coincidence rate was 95.1%, negative coincidence rate was 92.7%, with a total coincidence rate of 95.4% （ by chi-square test,P 〉 0.05 ）.VacA positive coincidence rate was 91.6%,negative coincidence rate was 97.1%, with a total coincidence rate of 95.2% （by chi-square test, P 〉 0.05 ） .The results of the two methods had no statistically significant difference in statistical test. Conclusion Through analysis of the above results, there were 476 effective cases in this clinical test, where the consistent rates of both Dayua

关 键 词：幽门螺杆菌抗体 分型 蛋白芯片法 免疫印迹法 

分 类 号：R446[医药卫生—诊断学]