QUALITY CONTROL TOOL FOR NEWBORN SCREENING BLOOD SAMPLES

基本上，美国（每年约400万）和至少30个其他国家的所有新生儿都要在滤纸卡上采集血液样本，以筛查一些代谢和遗传疾病。为了预防代谢疾病（如苯丙酮尿症或先天性甲状腺功能减退症）的发病，如脑损伤，及时获得筛查结果至关重要。新生儿筛查项目的一个长期存在且有充分证据的问题是，检测实验室的血卡样本不足。这导致了昂贵的召回测试，并在疾病诊断方面带来了危险的延误。本一期项目旨在测试计算机成像方法在患者接触部位检测血卡不足的敏感性和特异性。这将允许立即纠正问题，节省医疗保健费用，并防止诊断重要代谢疾病的任何不必要的延误。建议的商业应用：该项目将建立一个基于计算机的质量控制系统，解决新生儿筛查项目长期存在的令人烦恼的问题，并节省大量的医疗费用。同时，它将提高筛选程序的性能。这些有益的影响将结合在一起，确保该项目在一个仅在美国每年就有400万患者的大型医疗保健市场取得商业成功。

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.