QUALITY CONTROL TOOL FOR NEWBORN SCREENING BLOOD SAMPLES

基本上，美国(每年约400万)和其他至少30个国家的所有新生儿都有滤纸卡上的血液样本，用于筛查一些代谢性和遗传性疾病。为了预防苯丙酮尿症或先天性甲状腺功能减退症等代谢性疾病的发病率，及时获得筛查结果是至关重要的。新生儿筛查项目的一个长期存在的问题是血卡样本送到检测实验室的情况不充分。这导致了昂贵的回忆测试，并在疾病诊断方面引入了危险的延迟。这个第一阶段的项目旨在测试计算机成像方法的敏感性和特异性，以检测患者接触部位的不充分血卡。这将使问题立即得到纠正，节省医疗保健费用，并防止在诊断重要代谢性疾病方面出现任何不必要的延误。拟议的商业应用：该项目将产生一个基于计算机的质量控制系统，该系统将解决新生儿筛查计划面临的长期困扰的问题，并节省大量医疗保健资金。同时也提高了筛查方案的性能。这些有益的影响结合在一起，将确保该项目在一个仅在美国就代表着每年400万患者的巨大医疗保健市场的商业成功。

Essentially all newborns in the United States (about 4 million per year) and at least 30 other countries have blood samples obtained on filter paper cards for the purpose of screening for a number of metabolic and genetic diseases. To prevent morbidity, such as brain damage, from metabolic diseases such as phenylketonuria or congenital hypothyroidism, it is critical that the screening results be obtained in a timely fashion. A persistent and well-documented problem for the newborn screening programs has been the arrival of inadequate blood card samples at the testing laboratories. These result in expensive recall testing and introduce a dangerous delay in the diagnosis of disease. This Phase I project is designed to test the sensitivity and specificity of a computer imaging approach to detect inadequate blood cards at the site of patient contact. This would allow for the immediate correction of the problem, saving health care dollars and preventing any unnecessary delay in the diagnosis of important metabolic diseases. PROPOSED COMMERCIAL APPLICATIONS: This project will result in a computer based quality control system that will solve a long standing and vexing problem facing the newborn screening programs and result in the savings of substantial health care dollars. At the same time it will improve the performance of the screening program. These beneficial effects will combine to assure the commercial success of this project in an arena that will represent a large health care market of 4 million patients per year in the United States alone.