A novel method to detect Helicobacter pylori in children

描述（由申请人提供）：在雪崩的宣传围绕H。在幽门螺杆菌感染方面，儿童一直是人口中几乎被忽视的一部分。然而，越来越多的证据表明，儿童，特别是少数民族儿童，通常患有这种疾病。除了繁琐的内窥镜检查外，没有FDA批准的检测方法来检测活性H。小儿幽门螺杆菌我们打算解决这一需要一个简单的，微创和准确的诊断测试的儿童。代谢解决方案已经开发了一种测试来确定活性H的存在。pylori感染，我们将其命名为Ez-HBT（TM）。虽然这是一种血液测试，但不应与检测抗体存在的血清学测试混淆。Ez-HBT（TM）比基于抗体的测试优越上级，因为它检测胃尿素酶活性的存在。尿素酶活性仅在H.幽门螺杆菌已经在胃里定植了。测试开始于患者口服13 C-尿素（非放射性标记）。与胃H.幽门螺杆菌将尿素分解成13 CO2和氨。这导致血液中二氧化碳的13 C/12 C比率增加，如果H。幽门螺杆菌存在于胃中。H.幽门螺杆菌感染会损害儿童的生长发育和在学校的表现能力，并可能对胃癌产生长期影响。Ez-HBT（TM）的简单性，包括没有测试餐，一个片剂，可以溶解在一杯水和一个单一的传统静脉穿刺，使其成为一个理想的和成本效益的工具，用于识别H。儿童幽门螺杆菌感染

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.