Quality Control Tool for Newborn Screening Blood Samples

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44HD037789-04
Agency Tracking Number: HD037789
Amount: $313,376.00
Phase: Phase II
Program: SBIR
Awards Year: 2007
Solicitation Year: 2007
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
DUNS: 120672589
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 (520) 325-4505
Business Contact
Phone: (520) 325-4505
Email: ercraine@wrc-inc.com
Research Institution
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.

* Information listed above is at the time of submission. *

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