Wu I-Chen, Ke Hung-Lung, Lo Yi-Ching, Yang Yuan-Chieh, Chuang Chieh-Han, Yu Fang-Jung, Lee Yi-Chen, Jan Chang-Ming, Wang Wen-Ming, Wu Deng-Chyang
Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Shih-Chuan, 1st Road, Kaohsiung City, 807, Taiwan.
Hepatogastroenterology. 2003 Nov-Dec;50(54):1761-5.
BACKGROUND/AIMS: Several strategies have been used to detect Helicobacter pylori (Hp) infection along two lines: 1) direct detection of the bacteria, and 2) detection of antigen-antibody assay against Hp. The non-invasive methods include ELISA test of serum, salivary and urine, urea breath test, and detection of Hp antigen in stool. The latter method (HpSA) has been proven reliable and better than the ELISA test, for it can detect current Hp infection and is suitable for post-treatment follow-up. Now, a new commercial kit, ImmunoCard STAT HpSA (Meridian Bioscience Europe) has been developed to detect stool Hp antigen. It is simpler and less time-consuming than HpSA. The aim was to examine whether ImmunoCard STAT HpSA is qualified for diagnosis of Hp infection.
253 patients (163 men, 90 women, mean age: 53.3 +/- 13.9 y/o, range: 19-89 y/o) were enrolled in this study. All of them had undergone gastroendoscopy and urea breath test. 207 patients were diagnosed with peptic ulcer and 46 with gastritis. Stool samples were collected within 3 days of their visit for gastroendoscopy and were sent for the Immunocard test.
118 patients were diagnosed with Hp infection and of these, 113 were interpreted as positive by means of the Immunocard test. Among the other 135 patients without Hp infections, 123 were interpreted as negative by means of the Immunocard test. Sensitivity and specificity were 95.8% and 91.1%, and positive and negative predictive values were 90.4% and 96.1%.
The ImmunoCard STAT HpSA had high sensitivity, and specificity and could be used for mass screening. We concluded that it is a rapid, simple, cheap, reliable, and non-invasive strategy to detect current Hp infection and can be used in post-Hp eradication follow-up in Taiwan.
背景/目的：已采用多种策略沿两条途径检测幽门螺杆菌（Hp）感染：1）直接检测细菌；2）检测针对Hp的抗原-抗体检测。非侵入性方法包括血清、唾液和尿液的ELISA检测、尿素呼气试验以及粪便中Hp抗原的检测。后一种方法（HpSA）已被证明可靠且优于ELISA检测，因为它可以检测当前的Hp感染，并且适用于治疗后的随访。现在，一种新的商业试剂盒，免疫卡STAT HpSA（子午线生物科学欧洲公司）已被开发用于检测粪便Hp抗原。它比HpSA更简单且耗时更少。目的是检验免疫卡STAT HpSA是否有资格用于诊断Hp感染。
本研究纳入了253例患者（163例男性，90例女性，平均年龄：53.3±13.9岁，范围：19 - 89岁）。他们均接受了胃镜检查和尿素呼气试验。207例患者被诊断为消化性溃疡，46例为胃炎。在进行胃镜检查的3天内收集粪便样本并送去进行免疫卡检测。
118例患者被诊断为Hp感染，其中113例通过免疫卡检测被判定为阳性。在其他135例未感染Hp的患者中，123例通过免疫卡检测被判定为阴性。敏感性和特异性分别为95.8%和91.1%，阳性和阴性预测值分别为90.4%和96.1%。
免疫卡STAT HpSA具有高敏感性和特异性，可用于大规模筛查。我们得出结论，它是一种快速、简单、廉价、可靠且非侵入性的检测当前Hp感染的策略，可用于台湾地区Hp根除后的随访。
