Breath Ammonia Method for H. pylori Detection

描述（由申请人提供）：该项目将开发一个简单的测试， 胃内活动性幽门螺杆菌感染的非侵入性诊断 是基于测量病人呼吸中的氨高度敏感的小说 光学技术将被用来测量呼吸氨，导致一个 廉价的诊断程序，可以在任何一般的 医生的办公室。改良的胃H. pylori是 临床意义，因为有机体是大多数消化性溃疡的原因 并且与包括癌症在内的其它胃肠道疾病有关。的 一种新的呼吸氨传感方法将有助于感染的诊断 患者，以及用于感染状态的随访测定， 疗法 第一阶段的结果表明，100%的协议与传统的 14C标记的呼吸测试该研究将优化临床 仪器，扩大I期临床试验的范围到更大， 更多样化的患者集，并研究最大限度地提高临床 测试的诊断价值。本工作将对传感器和仪器进行重新设计 作为最终产品商业化的一个合理和实际的步骤。后续 商业化的上市前测试将实施这些工具， 测试程序并确认其临床功效。

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.