A novel method to detect Helicobacter pylori in children

描述(申请人提供)：在围绕幽门螺杆菌感染的铺天盖地的宣传中，儿童一直是实际上被忽视的人群中的一个部分。然而，越来越多的证据表明，儿童，特别是少数民族儿童，普遍患有这种疾病。除了繁琐的基于内窥镜的测试外，没有FDA批准的测试来检测儿童中活跃的幽门螺杆菌。我们打算满足这一需求，为儿童提供一种简单、微创和准确的诊断测试。新陈代谢解决方案公司开发了一种测试方法，以确定是否存在活性幽门螺杆菌感染，我们将其命名为EZ-HBT(TM)。虽然这是一项血液测试，但不应与检测抗体存在的血清学测试混淆。EZ-HBT(TM)优于基于抗体的检测，因为它能检测胃尿素酶活性的存在。只有当幽门螺杆菌在胃中定植时，尿素酶才有活性。测试开始于患者口服剂量的13C-尿素(非放射性标签)。与胃幽门螺杆菌相关的酶尿素酶将尿素分解为13CO2和氨。如果胃中存在幽门螺杆菌，这会导致血液二氧化碳中13C/12C的比率增加。幽门螺杆菌感染损害了儿童的生长发育和在学校的能力，并可能对胃癌产生长期影响。EZ-HBT(TM)的简单性，包括无需试餐、一片可溶于一杯水的药片和一次传统静脉穿刺术，使其成为确定儿童幽门螺杆菌感染的理想且成本效益高的工具。

DESCRIPTION (provided by applicant): In the avalanche of publicity surrounding H. pylori infection, children have been the one segment of the population that has been virtually ignored. However, there is a growing body of evidence that children, and especially minority children, are commonly afflicted with this disease. There are no FDA approved tests, other than the onerous endoscopic-based tests, to detect active H. pylori in children. We intend to address this need for a simple, minimally invasive and accurate diagnostic test for children. Metabolic Solutions has developed a test to determine the presence of active H. pylori infection that we named the Ez-HBT(TM). Although this is a blood test it should not be confused with serology tests that detect the presence of antibodies. The Ez-HBT(TM) is superior to antibody based tests because it detects the presence of gastric urease activity. Urease activity is only present when H. pylori have colonized the stomach. The test begins with the patient ingesting an oral dose of 13C-urea (non-radioactive label). The enzyme urease associated with gastric H. pylori breaks urea down into 13CO2 and ammonia. This results in an increase in the ratio of 13C/12C in blood carbon dioxide if H. pylori are present in the stomach. H. pylori infection impairs a child's growth, ability to function in school and may have long term implications for gastric cancer. The simplicity of the Ez-HBT(TM) including no test meal, a tablet that can be dissolved in a glass of water and a single traditional venipuncture makes it an ideal and cost effective tool for identifying H. pylori infection in children.