Development of a Point-Of-Care Test for Determining Bilirubin in Whole Blood

DESCRIPTION (provided by applicant): Neonatal hyperbilirubinemia (excessive bilirubin) is one of the most common problems encountered in newborns. If caught in time, hyperbilirubinemia can be treated. In a newborn infant, severe hyperbilirubinemia can cause brain damage (kernicterus), hearing loss, physical abnormalities, and even death. Recently, there has been a re-emergence of kernicterus, a preventable brain injury resulting from severe neonatal hyprbilirubinemia. This is due to early discharge after delivery, inaccurate bilirubin measurements, and improper management of the patients. The average hospital stay for a newborn delivered vaginally in 1970 was 3.9 days; today the average hospital stay is 1.7 days. Newborn bilirubin levels, however, do not peak until sometime between the third and fifth day after birth. With early discharge, the opportunity and responsibility for observing the newborn during the period of greatest extreme hyperbilirubinemia risk has shifted from the hospital to the primary caregiver. The American Academy of Pediatrics (AAP) revised their clinical practice guidelines for managing hyperbilirubinemia in 2004. The new guidelines recommend that all bilirubin levels be interpreted according to the infant's age in hours. Therefore, bilirubin test in newborns must be processed and reported urgently. Laboratories conducting testing may not be able to provide results in the relatively short time frame required for appropriate treatment decisions. This application proposes the development of a minimally invasive, inexpensive, point-of-care test that will provide the caregiver, both in the hospital and the office, direct and immediate access to whole blood total bilirubin levels. The test consists of a solid-phase test strip and reflectance based meter, similar to glucose models. Specific aims of the Phase I research have all been met. The goal of the Phase II proposal is to develop a final prototype solid phase test strip and hand-held digital reader. Phase II has three major aims: (1) finish development of the cassette and evaluate its performance; (2) develop reader with connectivity features; and (3) scale-up the manufacturing process and evaluate the casettes for performance using new reader. In Phase III commercialization phase, the main focus will be to sign up marketing partners, secure additional funding to prepare the product for launch, and by performing clinical studies to collect data for regulatory market approvals. The availability of the proposed PortaTBili product will prevent delays in finding those infants destined to develop severe hyperbilirubinemia, making significant impact in the nation's health management for infants. The low cost instrument will also allow improvement in infant healthcare practice globally. PUBLIC HEALTH RELEVANCE: The proposed test strip will allow a physician to determine an infant's total bilirubin concentration from a whole blood sample without having to send out to a lab. With this information, the physician can identify and treat infants who are at high risk for bilirubin related conditions that are life threatening or that will adversely affect the quality of life.