Novel Urea Breath Test for H. Pylori Diagnosis

描述(由申请人提供)：我们建议开发一种新的幽门螺杆菌诊断方法。幽门螺杆菌感染的诊断是医学上的高度优先事项，因为：这种细菌感染了大约50%的世界人口；导致消化性溃疡疾病、胃腺癌、粘膜相关淋巴组织淋巴瘤和可能的几种其他疾病；可以用抗生素治疗，但如果不根除这种细菌，患者仍有严重并发症的风险。在幽门螺杆菌的众多诊断试验中，尿素呼气试验(UBT)是最好的：它简单，无创，具有良好的敏感性和特异性，可以诊断当前的感染。它是基于幽门螺杆菌利用其酶尿素酶将尿素转化为二氧化碳和氨的能力。UBT的当前实施例使用13C-尿素或放射性14C-尿素，并检测呼气中标记的二氧化碳。放射性UBT很少使用。目前的非放射性UBT没有得到广泛使用，因为它们价格昂贵，而且在护理时无法获得。我们建议开发一种简单的UBT，以未标记尿素为底物，并在非常简单的设备中结合纳米传感器来检测呼气中的氨。在这份修订后的申请中，我们解决了以前审查员的关切，并提供了大量初步数据，证明了我们方法的可行性。它们包括具有适当灵敏度和特异度的传感器以及原型设备的开发。我们的具体目标是1)优化我们的纳米传感器，以测定呼气空气中的氨含量，以及2)开发一种用于测定呼气中氨的原型装置。拟议的UBT将是简单、廉价、非侵入性的，并且可以在护理地点获得。因此，它将成为一种广泛使用的简单设备，用于幽门螺杆菌的诊断和疗效监测。我们的方法有可能以直接、直接和重大的方式影响人类健康，并产生商业上可行的产品。公共卫生相关性：我们建议开发一种简单易用且廉价的设备来快速诊断幽门螺杆菌感染。这种微生物感染了大约50%的世界人口，并导致消化性溃疡和胃癌。该设备对公众健康的影响将是立竿见影的。

DESCRIPTION (provided by applicant): We propose to develop a novel method for the diagnosis of Helicobacter pylori. The diagnosis of H. pylori infection is a high medical priority because: this bacterium infects approximately 50% of the world's population; causes peptic ulcer disease, gastric adenocarcinoma, mucosa-associated lymphoid tissue lymphoma and likely several other diseases; and is treatable with antibiotics but if this organism is not eradicated, patients remain at risk for serious complications. Of the many diagnostic tests for H. pylori, the urea breath test (UBT) is the best: it is simple, noninvasive, has excellent sensitivity and specificity and can diagnose current infection. It is based on the ability of H. pylori to convert urea to CO2 and ammonia using its enzyme urease. Current embodiments of UBT employ 13C-urea or the radioactive 14C- urea and detect labeled CO2 in breath. The radioactive UBT is rarely used. Current non- radioactive UBTs are not extensively used because they are costly and not available at the point of care. We propose to develop a simple UBT using as a substrate unlabeled urea and detecting ammonia in breath with a nanosensor incorporated in a very simple device. In this revised application, we have addressed the concerns of the previous reviewers and present extensive preliminary data demonstrating the feasibility of our approach. They include a sensor with appropriate sensitivity and specificity and development of a prototype device. Our specific aims are to 1) Optimize our nanosensor for the determination of ammonia levels in breath air, and 2) Develop a prototype device for the determination of ammonia in breath. The proposed UBT will be simple, inexpensive, noninvasive and available at the point-of-care. Thus it will make widely available a simple device for the diagnosis of H. pylori and the monitoring of treatment efficacy. Our method has the potential to impact human health in an immediate, direct and major way and generate a commercially viable product. PUBLIC HEALTH RELEVANCE: We propose to develop a simple-to-use and inexpensive device to diagnose rapidly infection with of Helicobacter pylori. This organism infects approximately 50% of the world's population and causes peptic ulcer and gastric cancer. The device's impact on public health will be immediate and major.