A Point-Of-Care Device for the Determination of the Bilirubin, the BiliNow
Grant Number: 1R43HD095727-01
Grant Agency and Type: NIH NICHD, Phase I SBIR
Principal Investigator: Robert Harper
Disease Indication: Kernicterus
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 of readmission of newborns to the hospital in the first two 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 to lose 15-30% of circulating blood volume to laboratory testing.” A NICHD workshop on NICUs concluded that there is an urgent need for metabolic analysis methods that require minimal volumes of blood, can measure analytes in parallel, and are accurate, reliable, and cost-effective. 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 bilirubin 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%; and 3) 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 conjugated and unconjugated bilirubin levels 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 converted to a concentration in 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.
Results and Commercialization Status
Results showed excellent agreement with spiked blood samples for both conjugated and unconjugated bilirubin. IVDS will be applying for a Phase II application in Q1 of 2021. We are finalizing our Phase I Close-Out Report.