Infection with Helicobacter pylori is a global health issue, and rapid and accurate testing is a key to diagnosis. We aimed to assess the performance of two novel enzyme immunoassays (EIA), the H. PYLORI QUIK CHEK™ and the H. PYLORI CHEK™ assays, for the detection of H. pylori antigen in stool. Patients from five geographically diverse sites across the USA, Germany, and in Bangladesh were tested for infection with Helicobacter pylori with the two novel stool antigen tests and two commercially available stool antigen assays. All patients provided a stool sample and underwent esophagogastroduodenoscopy for biopsy. Results were compared to a clinical diagnosis using a composite reference method consisting of histological analysis and rapid urease testing of the biopsy. A total of 271 patients, 68.2% female and mean age of 46 years, were included. The overall prevalence of H. pylori infection was 24.1%. The sensitivity of the H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ was 92% and 91%, respectively. The specificity of H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ was 91% and 100%, respectively. No significant cross-reactivity against other gut pathogens was observed. The H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ assays demonstrate excellent clinical performance compared the composite reference method.

幽门螺杆菌感染是一个全球性的健康问题，快速准确的检测是诊断的关键。我们旨在评估两种新型酶免疫测定 (EIA) 的性能，即 H. PYLORI QUIK CHEK™ 和 H. PYLORI CHEK™ 测定，用于检测粪便中的幽门螺杆菌抗原。来自美国、德国和孟加拉国五个不同地点的患者接受了幽门螺杆菌感染检测使用两种新型粪便抗原检测和两种市售粪便抗原检测。所有患者均提供粪便样本并接受食管胃十二指肠镜活检。使用由组织学分析和活检的快速尿素酶测试组成的复合参考方法，将结果与临床诊断进行比较。总共包括 271 名患者，其中 68.2% 为女性，平均年龄为 46 岁。幽门螺杆菌的总体患病率感染率为24.1%。H. PYLORI QUIK CHEK™ 和 H. PYLORI CHEK™ 的灵敏度分别为 92% 和 91%。H. PYLORI QUIK CHEK™ 和 H. PYLORI CHEK™ 的特异性分别为 91% 和 100%。未观察到对其他肠道病原体的显着交叉反应。与复合参考方法相比，H. PYLORI QUIK CHEK™ 和 H. PYLORI CHEK™ 检测显示出出色的临床性能。