摘要
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。
Aims: To evaluate the accuracy of a newly developed enzyme immunoassay for detection of Helico-bacter pylori (H. pylori) stool antigen (HpSA). Methods: HpSA was detected using enzyme immunoassay. Nine hundred and ninety five patients underwent endoscopy for evaluation of dyspepsia were included in this multicenter study. The status of H. pylori infection was determined in all patients by stool HpSA test, rapid urease test (RUT) and histology (or culture). Combined detection of RUT and histology (or culture) was used as gold standard for evaluating the accuracy of HpSA test in determining H. pylori status. Patients were defined as positive for H. pylori if RUT and histology (or culture) were positive. Results: The sensitivity of HpSA test for the diagnosis of H. pylori infection using a cutoff value of 0.16 was 93.5% (478/511) and its specificity was 94.2% (456/484). The positive predictive and negative predictive values were 94.5% (478/506) and 93.3% (456/489), respectively, and total accuracy 93.9% (934/995). Conclusions: HpSA test is simple, noninvasive and highly accurate in the diagnosis of H. pylori infection.
出处
《胃肠病学》
2002年第3期136-139,共4页
Chinese Journal of Gastroenterology
