QUALITY CONTROL TOOL FOR NEWBORN SCREENING BLOOD SAMPLES

用于新生儿筛查血样的质量控制工具

• 批准号: 6072150
• 负责人: BRIAN L CRAINE
• 金额: $ 9.7万
• 依托单位: WESTERN RESEARCH COMPANY, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-06-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6072150
• 关键词: bioengineering /biomedical engineering; bioimaging /biomedical imaging; biomedical equipment development; charge coupled device camera; diagnosis quality /standard; genetic disorder diagnosis; health care quality; hemoglobin; imaging /visualization /scanning; mass screening; metabolism disorder diagnosis; newborn human (0-6 weeks); photography; serology /serodiagnosis; statistics /biometry

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.

在美国（每年约400万）和至少30个其他国家，基本上所有新生儿都有滤纸卡上的血液样本，用于筛查一些代谢和遗传疾病。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引起的脑损伤等发病率，及时获得筛查结果至关重要。新生儿筛查项目的一个持续存在的、有充分记录的问题是，检测实验室的血卡样本不足。这些导致昂贵的召回测试，并在疾病诊断中引入危险的延迟。该I期项目旨在测试计算机成像方法的灵敏度和特异性，以检测患者接触部位的不适当血卡。这将有助于立即纠正问题，节省医疗保健费用，并防止重要代谢疾病的诊断出现任何不必要的延误。拟议的商业应用：该项目将导致一个基于计算机的质量控制系统，将解决一个长期存在的和令人烦恼的问题所面临的新生儿筛查计划，并导致节省大量的医疗保健美元。与此同时，它将提高筛查方案的绩效。这些有益效果将联合收割机结合起来，以确保该项目在竞技场中的商业成功，该竞技场将代表仅在美国每年400万患者的大型医疗保健市场。