Neonates with high bilirubin levels can develop a fatal disorder known as Kernicterus. Kernicterus has a death rate of 2-3% and causes brain damage and serious long-term complications. High bilirubin levels are the leading cause for readmission of newborns to the hospital in the first 2 weeks of life. Current laboratory analyzers require a venipuncture for neonates, which is difficult for the care-provider, patient and parent. ?With the onset of illness, it is not uncommon for neonates lose 15-30% of circulating blood volume to laboratory testing.? A NICHD workshop on NICUs concluded that there is a urgent need for metabolic analysis methods that require minimal volumes of blood, can measure analytes in parallel, and are accurate, reliable, and cost-effective (Raju, 2009). A recent report by Market Research Future, states that by 2024 the Bilirubin Testing market will reach 2.5 billion dollars. In Vitro Diagnostic Solutions (IVDS) proposes the development of the first and only point-of-care (POC) system, the ?BiliNow?, for the determination of bilirubins from a finger or heel-stick. The ?BiliNow? will be used in the Neonatal Intensive Care Unit (NICU), emergency room (ER), intensive care units (ICU) and clinician?s office providing immediate feedback to expedite treatment. The BiliNow utilizes a microfluidic chip format that is minimally invasive, requiring only 30 microliters of whole blood, which is collected from a heel-stick or fingerstick. In Phase I studies, we will: 1) Test solubilizing agents to ensure complete solubility of unconjugated bilirubin; 2) Test and eliminate hematocrit bias in the neonatal range of 32 to 60%; 3) and finally, Evaluate a dose response of bilirubin with whole blood samples. Microchips will be dosed and dried with chromophore-sensors specific for conjugated and unconjugated bilirubin. Whole blood will be spiked with each conjugated and unconjugated bilirubin, over the analytical ranges. Plasma will be separated, in-situ, and the end-color of each sensing-well will be quantitated using percent reflectance and calculated mg/dL, via a hand-held, portable analyzer, similar to the glucose model. The BiliNow provides results for both conjugated and unconjugated bilirubin in a single step within 3 minutes. The BiliNow technology has a clear advantage in the neonatal blood chemistry market as no other device can measure bilirubin, from a single drop of blood. Upon successful completion of the Phase I Aims, Phase II will focus on optimization of the platform to ensure linearity and precision, establish intra-day and inter-day precision under Clinical and Laboratory Standards Institute guidelines, and evaluate preclinical samples with the BiliNow comparing results against an FDA approved method, the Br2 analyzer.
High bilirubin levels are the leading cause for readmission of newborns to the hospital in the first 2 weeks of life. In some instances, babies with high bilirubin levels can develop a fatal disorder known as Kernicterus. In Vitro Diagnostic Solutions (IVDS) proposes to develop a lab-on-a-chip, point-of-care system, the BiliNow, which will be able to quantify conjugated and unconjugated bilirubin directly from a single drop of blood.
