检验医学 ›› 2014, Vol. 29 ›› Issue (4): 350-356.DOI: 10.3969/j.issn.1673-8640.2014.04.013

• 技术研究与评价·论著 • 上一篇    下一篇

多重基因分析系统检测幽门螺杆菌的初步研究

周丽芳1,保志军2,缪应新1,季大年3,黄一沁1,赵付菊1,赵虎1   

  1. 1. 复旦大学附属华东医院检验科,上海 200040;
    2. 复旦大学附属华东医院消化科,上海 200040;
    3.复旦大学附属华东医院内镜室,上海 200040
  • 收稿日期:2013-08-09 出版日期:2014-04-30 发布日期:2014-06-06
  • 通讯作者: 赵虎,联系电话:021-62483180。
  • 作者简介:周丽芳,女,1988年生,硕士,主要从事临床微生物学研究。
  • 基金资助:

    上海市科学技术委员会重点科研项目(134119a1700);上海市申康医院发展中心“市级医院新兴前沿技术联合攻关项目”(SHDC12013123);上海市卫生局重点科研项目(20134008)

The preliminary evaluation of multiple genetic analysis system to detect Helicobacter pylori

ZHOU Lifang1, BAO Zhijun2,MIAO Yingxin1,JI Danian3,HUANG Yiqin1,ZHAO Fuju1,ZHAO Hu1.   

  1. 1.Department of Clinical Laboratory, Huadong Hospital, Fudan University, Shanghai 200040, China;
    2. Department of Gastroenterology, Huadong Hospital, Fudan University, Shanghai 200040, China;
    3. Endoscopic Room, Huadong Hospital, Fudan University, Shanghai 200040, China
  • Received:2013-08-09 Online:2014-04-30 Published:2014-06-06

摘要:

目的 评估一种全新的幽门螺杆菌(HP)检测方法,即利用多重基因分析系统(GeXP系统)检测HP感染。方法 分别用培养法、快速尿素酶法、普通聚合酶链反应(PCR)和多重基因检测法检测胃活检组织标本中的HP,用Stata 12.0统计软件评估各种方法的敏感性、特异性、阳性预测值、阴性预测值,从检测方法角度横向评估多重基因法检测HP 的有效性;选取16S rRNAureAureC26KDacagA基因作为HP 的诊断基因并做多重基因检测,从多重基因检测角度纵向评估GeXP系统检测HP感染的有效性。结果 培养法的敏感性为76.8%,特异性为100.0%,阳性预测值为100.0%,阴性预测值为57.7%;快速尿素酶法的敏感性为87.8%,特异性为80.8%,阳性预测值为93.5%,阴性预测值为67.7%;普通PCR的敏感性和特异性最高,均为100.0%GeXP系统敏感性和特异性分别为100.0%71.3%,阳性预测值为90.9%,阴性预测值为100.0%结论 初步建立的诊断HP感染的多重基因检测法(GeXP系统)具有高敏感性、高特异性以及高通量的特点,不仅可以满足临床标本检测的需求,还可以进行根除治疗后的预后监测,具有很高的临床应用价值。

关键词: 多重基因检测法, GeXP系统, 幽门螺杆菌, 鉴定, 基因, 高通量

Abstract:

Objective To evaluate a new kind of Helicobacter pyloriHP detection method using the multiple genetic analysis systemGeXP system to detect HP infection. Methods Use culture method rapid urease test ordinary polymerase chain reactionPCR and multiple genetic testing to determine whether gastric biopsies exist HP. The sensitivity specificity positive predictive value and negative predictive value were evaluated by Stata 12.0 statistical software in order to evaluate the testing performance of GeXP system from horizontal degree. Furthermore multiple genetic testing was performed by selecting 5 specific genes16S rRNA, ureA, ureC, 26KDa and cagA genesas HP diagnosis infection and multiple genetic testing was evaluated from longitudinal degree. Results The sensitivity of culture method was 76.8% the specificity was 100.0% the positive predictive value was 100.0% and the negative predictive value was 57.7%. For rapid urease test by contrast its sensitivity was 87.8% the specificity was 80.8% the positive predictive value was 93.5% and the negative predictive value was 67.7%. Ordinary PCR had the highest sensitivity and specificity100.0%. For GeXP system the sensitivity was 100.0% the specificity was 71.3% without false negative case the positive predictive value was 90.9% and the negative predictive value was 100.0%. Conclusions The new preliminary multiple genetic testing GeXP system has high sensitivity and specificity and high flux characteristics which would not only meet the needs of clinical sample determination but also could monitor prognosis after receiving eradication therapy. The GeXP system has a promising application significance.

Key words: Multiple genetic analysis, GeXP system, Helicobacter pylori, Identification, Gene, High flux

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