QUALITY CONTROL TOOL FOR NEWBORN SCREENING BLOOD SAMPLES

Western Research Company, Inc., Tucson AZ

Investigators

Abstract

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.