An evaluation of a serologic test with a current infection marker of Helicobacter pylori before and after eradication therapy in Chinese
An evaluation of a serologic test with a current infection marker of Helicobacter pylori before and after eradication therapy in Chinese
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中国人根除治疗前后幽门螺杆菌当前感染标志物血清学检测的评价
DOI：
10.1111/j.1523-5378.2008.00578.x
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发表时间：
2008-02-01
期刊：
影响因子：
4.4
通讯作者：
Zhang, Guo Xin
中科院分区：
文献类型：
--
作者：
Wang, Xiao Yong;Yang, Yang;Zhang, Guo Xin
背景和目的：发展一种准确、简便的非侵入性方法来检测当前幽门螺杆菌的感染在临床上是非常必要的。这项研究的目的是评估CIM检测的性能，也被称为Assue(R)Hp快速检测(Genelabs Diagnostics Pty)。方法：以江苏省中国为研究对象，对中国人群根除治疗前后幽门螺杆菌感染现状进行诊断。每个人都接受了C-13尿素呼气试验(C-13-UBT)。为了评估根除后的CIM试验，115例Hp阳性的门诊患者接受了为期1周的三联疗法。治疗结束后1个月再次进行C-13-UBT检查，并于治疗结束后1、3、6个月进行CIM测试。以C-13-UBT作为诊断幽门螺杆菌的金标准，检测其敏感性、特异性、阳性预测值和阴性预测值及准确性。结果：337人中有221人(65.6%)用C-13-UBT检出H.以C-13-UBT为金标准，CIM试验的敏感性为93.2%，特异性为90.5%，阳性预测值为94.9%，阳性预测值为87.5%，阴性预测值为92.3%。CIM试验在根除治疗后1个月的敏感性和特异性分别为50%和66.7%，在根除治疗后3个月的敏感性和特异性分别为66.7%和84.6%，在抗-H抗体治疗结束6个月后CIM试验的敏感性和特异性分别增加到85.7%和96.9%。结论：CIM检测是一种简便、快速、准确、廉价、亲人的检测方法。在未经根除治疗的病例中检测幽门螺杆菌感染可能是令人满意的，但在抗-H后6个月内不能正确区分过去或现在的感染。幽门螺杆菌疗法。
Background and Aims: Development of an accurate and less cumbersome noninvasive method to detect current Helicobacter pylori infection is essential in clinic. The aim of this study was to evaluate the performance of the CIM test, also known as the Assure (R) H. pylori Rapid Test (Genelabs Diagnostics Pty. Ltd., Singapore), for the diagnosis of current H. pylori infection before and after eradication therapy in Chinese population.Methods: A total of 452 eligible people were recruited for this study in Jiangsu Province, China. Each individual underwent a C-13 urea breath test (C-13-UBT). For the evaluation of CIM test after eradication, 115 H. pylori-positive outpatients were treated with 1-week triple therapy. One month after the end of therapy, the patients underwent C-13-UBT again, and the CIM-test was performed 1, 3, and 6 months after the end of therapy. Its performance (sensitivity, specificity, positive and negative predictive values, and accuracy) were determined using the C-13-UBT as a gold standard for H. pylori diagnosis.Results: H. pylori was detected in 221 (65.6%) of the 337 people by C-13-UBT. The sensitivity, specificity, positive and negative predictive values, and accuracy of the CIM test were 93.2%, 90.5%, 94.9%, 87.5%, and 92.3%, respectively, using C-13-UBT as a gold standard. One month after eradication therapy, the sensitivity, specificity of CIM test were only 50% and 66.7%, 66.7% and 84.6% 3-month after eradication therapy and the sensitivity, specificity increased to 85.7% and 96.9%, respectively, when CIM test was used 6 months after the end of anti-H. pylori therapy.Conclusions: The CIM test is a simple, rapid, accurate, cheap, and near-people test. It may be satisfactory for detecting H. pylori infection in cases without eradication therapy, but it could not differentiate the past or current infection correctly within 6 months after anti-H. pylori therapy.