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目的:评估幽门螺杆菌(H.pylori)粪便抗原(HpSA)试验诊断H.pylori感染的准确性。方法:应用酶免疫反应原理进行HpSA试验,在大样本、多中心研究中进行HpSA试验的评估。995例因消化不良症状接受胃镜检查者纳入本研究,所有患者均以HpSA试验、快速尿素酶试验(RUT)和组织学(或培养)方法检测H.pylori。以RUT和组织学(或培养)联合检测作为“金标准”,两项试验均阳性者定为H.pylori感染。结果:以光密度值≥0.16为阳性,HpSA检测诊断H.pylori感染的敏感性为93.5%(478/511),特异性为94.2%(456/484),阳性预测值为94.5%(478/506),阴性预测值为93.3%(456/489),总的检测准确性为93.9%(934/995)。结论:HpSA试验是一种简便、准确的非侵入性H.pylori感染检测方法。
Objective: To evaluate the accuracy of H.pylori stool antigen (HpSA) test in the diagnosis of H.pylori infection. Methods: The HpSA test was performed using the principle of enzyme immunoassay, and the HpSA test was evaluated in large sample, multicenter studies. A total of 995 patients with dyspeptic symptoms who underwent endoscopy were enrolled in this study. All patients were tested for H.pylori using the HpSA test, rapid urease test (RUT) and histological (or culture) methods. Rut and histology (or culture) joint test as the “gold standard”, two tests were positive for H.pylori infection. Results: The sensitivity of H.pylori infection was 93.5% (478/511), the specificity was 94.2% (456/484), the positive predictive value was 94.5% (478 / 506). The negative predictive value was 93.3% (456/489). The overall detection accuracy was 93.9% (934/995). Conclusion: HpSA test is a simple and accurate method for detecting non-invasive H.pylori infection.