A novel method to detect Helicobacter pylori in children

描述（由申请人提供）：在铺天盖地的关于幽门螺旋杆菌感染的宣传中，儿童一直是几乎被忽视的人群之一。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。除了繁重的内窥镜检查外，目前还没有FDA批准的检测儿童体内活性幽门螺杆菌的方法。我们打算解决这一需求，为儿童提供一种简单、微创和准确的诊断测试。代谢性解决方案公司开发了一种检测是否存在活动性幽门螺杆菌感染的方法，我们将其命名为Ez-HBT（TM）。虽然这是一种血液检查，但不应与检测抗体存在的血清学检查混淆。Ez-HBT（TM）优于基于抗体的测试，因为它检测胃脲酶活性的存在。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脲酶将尿素分解成13CO2和氨。如果胃中存在幽门螺旋杆菌，这就会导致血液中二氧化碳中13C/12C的比例增加。幽门螺杆菌感染会损害儿童的生长发育和在学校的学习能力，并可能对胃癌有长期的影响。Ez-HBT（TM）的简单性，包括不需要测试餐，可以溶解在一杯水中的片剂和单一的传统静脉穿刺，使其成为识别儿童幽门螺杆菌感染的理想和经济有效的工具。

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.