Breath Ammonia Method for H. pylori Detection

描述(由申请者提供)：该项目将开发一个简单的测试 胃幽门螺杆菌活动性感染的非侵入性诊断 基于对患者呼气中氨的测量。一部高度敏感的小说 光学技术将被用来测量呼气氨，导致 价格低廉的诊断程序，可以在任何一般情况下进行 从业者办公室。一种检测胃幽门螺杆菌的改进方法是 临床意义，因为细菌是大多数消化性溃疡的原因 并与包括癌症在内的其他胃肠道疾病有关。这个 新的呼气氨传感方法将用于感染的诊断 患者，以及术后感染状态的后续确定 心理治疗。 第一阶段的结果显示100%符合常规 14C-标记呼气测试这项研究将优化临床 仪器，将I期临床试验的范围扩大到更大的， 更多样化的患者集合，并研究测试参数，以最大限度地提高临床 该试验的诊断价值。这项工作将重新设计传感器和仪器 作为最终产品商业化的合乎逻辑和实际的一步。后续 商业化的上市前测试将实施这些仪器和 测试程序，并确认其临床疗效。

DESCRIPTION (provided by applicant): The project will develop a simple test for noninvasive diagnosis of active Helicobacter pylori infection in the stomach based on measuring ammonia in patients' breath. A novel highly sensitive optical technique will be used to measure breath ammonia, leading to an inexpensive diagnostic procedure that can be conducted in any general practitioner's office. An improved method of detecting gastric H. pylori is of clinical significance because the organism is the cause of most peptic ulcers and is associated with other gastrointestinal diseases including cancers. The new breath ammonia sensing method will be useful for diagnosis of infected patients, as well as for follow-up determinations of infectious status after therapy. Phase I results demonstrated 100 percent agreement with conventional 14C-labeled breath tests The research will optimize the clinical instrumentation, expand the scope of the Phase I clinical trial to a larger, more diverse patient set, and study test parameters that maximize the clinical diagnostic value of the test. This work will redisign the sensor and instrument as a logical and practical step to final product commercialization. Subsequent pre-market testing for commercialization will implement those instrument and test procedure and confirm their clinical efficacy.