Department of Internal Medicine and Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, South Korea.
J Gastroenterol Hepatol. 2011 Jun;26(6):1053-9. doi: 10.1111/j.1440-1746.2011.06705.x.
This study aimed to evaluate the efficacy of a new polyclonal enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigen in stool by determination of the optimal cut-off value in the screening population.
A consecutive 515 patients undergoing a routine health check-up were prospectively enrolled. H. pylori infection was defined if at least two of four tests (histology, rapid urease test, (13)C-urea breath test, and serology) were positive. A stool antigen test (EZ-STEP H. pylori) was performed for the detection of H. pylori. The optimal cut-off value was determined by the receiver-operator characteristic curve. The diagnostic performance of each test was evaluated with regard to the histological diagnosis of atrophic gastritis (AG)/intestinal metaplasia (IM), degree of AG/IM, and old age.
Sensitivity, specificity, positive and negative predictive values, and accuracy of the stool antigen test were 93.1%, 94.6%, 95.1%, 92.3%, and 93.8%, respectively. The sensitivity of histology, rapid urease test, and the (13)C-urea breath test ranged from 89.1% to 97.6%, and their specificity was > 98%, while serology had high sensitivity, but low specificity. The accuracy of the stool antigen test was comparable to that of other methods (93.6-95.9%), whereas it was higher than that of serology. The stool antigen test still showed good diagnostic performance in the setting of progression of AG/IM and in patients over 40 years.
The performance of a new stool antigen test was comparable to that of other methods in the diagnosis of H. pylori infection for the screening population, even with the presence of AG/IM.
本研究旨在评估一种新的多克隆酶免疫测定法（EZ-STEP H. pylori）检测粪便中幽门螺杆菌（H. pylori）抗原的效果，通过确定筛查人群中的最佳截断值来实现。
连续纳入 515 例行常规健康检查的患者。如果至少两种四项检测（组织学、快速尿素酶试验、（13）C-尿素呼气试验和血清学）呈阳性，则定义为 H. pylori 感染。对 H. pylori 进行粪便抗原检测（EZ-STEP H. pylori）。通过受试者工作特征曲线确定最佳截断值。根据组织学诊断萎缩性胃炎（AG）/肠上皮化生（IM）、AG/IM 程度和年龄对每种检测的诊断性能进行评估。
粪便抗原检测的敏感性、特异性、阳性预测值、阴性预测值和准确性分别为 93.1%、94.6%、95.1%、92.3%和 93.8%。组织学、快速尿素酶试验和（13）C-尿素呼气试验的敏感性范围为 89.1%至 97.6%，特异性均>98%，而血清学具有高敏感性，但特异性低。粪便抗原检测的准确性与其他方法相当（93.6%-95.9%），但高于血清学。在 AG/IM 进展和 40 岁以上患者中，粪便抗原检测仍具有良好的诊断性能。
对于筛查人群，新型粪便抗原检测的性能与其他方法相当，即使存在 AG/IM 时也是如此。
