A NEW CHLORIDE SWEAT TEST FOR CYSTIC FIBROSIS SCREENING

用于囊性纤维化筛查的新氯化物汗液测试

• 批准号: 6298895
• 负责人: WARREN J WARWICK
• 金额: $ 10万
• 依托单位: POLYCHROME MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2002-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6298895
• 关键词: biosensor device; chloride ion; cystic fibrosis; diagnosis design /evaluation; early diagnosis; metabolism disorder diagnosis; newborn human (0-6 weeks); sweat

We propose to develop a new sweat test kit that will be a diagnostic screening tool for detecting cystic fibrosis (CF) in infants. The test will produce a quantitative chloride value with the same accuracy as the current "gold standard" test known as the Gibson-Cooke Sweat Test (GCST). This new test will be easy-to-use, can be performed in a fraction of the time as the GCST, and require only 3-10 milligrams of sweat to produce an accurate test result. The main goals of Phase I are to produce a test kit that will perform well in clinical studies, develop a simple method to interpret the test results, and construct a calibration tool to insure the stability of the test. A new quantitative sweat test is needed because the prognosis for patients with CF improves markedly with early detection and subsequent prophylactic therapy. General agreement exists on the need to develop a screening test for asymptomatic infants before 6 weeks of age. Current techniques for diagnosis of CF are poorly suited to broad- based screening because of their cost, their high error rate, and or the practical and psychological burden they place upon the parents. This new test will address all these issues. PROPOSED COMMERCIAL APPLICATIONS: This research will lead to the development of a new quantitative chloride sweat test that will make it possible to screen asymptomatic infants for CF. The test will be cost-effective, easy to use, and therefore can be adapted to broad-based screening.

我们建议开发一种新的汗液检测试剂盒，作为检测婴儿囊性纤维化（CF）的诊断筛查工具。该测试将产生定量氯化物值，其准确度与当前的“金标准”测试（称为吉布森-库克汗水测试（GCST））相同。这项新测试易于使用，只需 GCST 的一小部分时间即可完成，并且只需 3-10 毫克汗液即可产生准确的测试结果。第一阶段的主要目标是生产一种在临床研究中表现良好的测试套件，开发一种简单的方法来解释测试结果，并构建一个校准工具以确保测试的稳定性。需要一种新的定量汗液测试，因为通过早期检测和随后的预防性治疗，CF 患者的预后显着改善。人们普遍认为有必要对 6 周龄前的无症状婴儿进行筛查测试。目前的 CF 诊断技术由于成本高昂、错误率高和/或给父母带来的实际和心理负担，不太适合广泛的筛查。这项新测试将解决所有这些问题。拟议的商业应用：这项研究将导致一种新的定量氯化物汗液测试的开发，使筛查无症状婴儿的 CF 成为可能。该测试具有成本效益、易于使用，因此可以适应广泛的筛查。