Quality Control Tool for Newborn Screening Blood Samples

新生儿筛查血液样本的质量控制工具

• 批准号: 7421047
• 负责人: BRIAN L CRAINE
• 金额: $ 22.62万
• 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 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7421047
• 关键词: Birthing Centers; Blood; Blood specimen; Brain Injuries; Clinical; Computers; Country; Cretinism; Data; Development; Devices; Diagnosis; Disease; Evaluation; Funding; Genetic screening method; Goals; Grant; Healthcare; Hereditary Disease; Image; Laboratories; Lead; Marketing; Medical Device; Mental Retardation; Metabolic; Metabolic Diseases; Monitor; Morbidity - disease rate; Neonatal Screening; Newborn Infant; Numbers; Paper; Patients; Phase; Point-of-Care Systems; Product Approvals; Purpose; Qualifying; Quality Control; Risk; Sampling; Screening Result; Screening procedure; Software Validation; Solutions; Specimen; System; Testing; United States; United States Food and Drug Administration; United States National Institutes of Health; Validation; base; design and construction; innovation; instrument; mortality; novel; prevent; programs; prototype; research and development; tool

DESCRIPTION (provided by applicant): 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 project will develop an imaging based system for the evaluation of blood cards to determine if they are adequate. Use of such a system at a birthing center will allow for the immediate correction of the problem, saving health care dollars and preventing any unnecessary delay in the diagnosis of important metabolic diseases. This project will result the development of a simple and economically advantageous computer based system for point of care use to determine if newborn screening blood sample cards are adequate for testing. This will allow for the immediate correction of inadequate cards prior to being sent to the lab for testing and while the newborn is still at the birthing center. The goal is to reduce dangerous delays in testing that can lead to avoidable morbidity and mortality associated with late diagnosis.

描述（由申请人提供）：美国（每年约400万）和至少30个其他国家的基本上所有新生儿都有滤纸卡上的血液样本，用于筛查许多代谢和遗传疾病。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。该项目将开发一个基于成像的系统，用于评估血液卡，以确定它们是否足够。在分娩中心使用这样的系统将允许立即纠正问题，节省医疗费用，并防止重要代谢疾病诊断的任何不必要的延误。该项目将开发一种简单且经济的基于计算机的系统，用于现场护理，以确定新生儿筛查血样卡是否足以进行检测。这将允许在送往实验室进行测试之前立即纠正不适当的卡，而新生儿仍在分娩中心。其目标是减少检测中的危险延误，这种延误可能导致与晚期诊断相关的可避免的发病率和死亡率。