BiliSpec: Low-Cost, Point-of-Care Bilirubin Measurement Device to Diagnose Neonatal Jaundice and Monitor Phototherapy
Agency: USAID Saving Lives at Birth
Collaborators: Rebecca Richards-Kortum (Rice), Robert Miros (3rd Stone Design), Queen Dube (Queen Elizabeth Central Hospital- Malawi)
During the first days of life, neonates are at increased risk of developing jaundice – when excess bilirubin builds up in the body. Lack of treatment can lead to severe neurological impairment and death. Fortunately, jaundice is easily treated with blue light phototherapy. In high resource settings morbidity and mortality from jaundice is exceedingly rare due to readily available bilirubin monitoring for guidance of effective phototherapy treatment. Several commercial phototherapy systems have been developed and marketed specifically for low-resource settings. However, accurate low-cost bilirubin monitoring is still widely unavailable in low-resource settings and systems used in high-resource settings are too expensive. Our idea is to develop BiliSpec, a bilirubin monitoring device with a per-test cost of less than $0.10. BiliSpec includes: (1) a lateral-flow device to separate serum from whole blood in under 30 seconds and (2) a battery powered reader to measure light transmission through the separated serum on the strip and display the bilirubin concentration. We estimate our device could prevent the deaths of approximately ninety-thousand neonates who die every year due to lack of access to effective treatment and monitoring for neonatal jaundice in low-resource settings.
We will develop and evaluate the effectiveness of our system to diagnose and monitor neonatal jaundice. Endpoints include: (1) completed design and laboratory validation of BiliSpec; (2) pilot study to evaluate the ability of BiliSpec to measure bilirubin levels in drops of whole blood from neonates; (3) clinic-ready prototype prepared for commercial manufacturing. This work will be completed by an established collaboration between Rice University, 3rd Stone Design, and Queen Elizabeth Central Hospital in Malawi.
With support from a Saving Lives at Birth seed grant, we will develop BiliSpec, a low-cost bilirubin measurement device for diagnosing neonatal jaundice. Our project has three aims: (1) In a series of laboratory studies in Houston, we will develop and rigorously evaluate the ability of the BiliSpec prototype to accurately measure bilirubin levels in spiked samples of whole blood. Results of the study will be used to refine the design of the device. (2) We will then evaluate the performance of the BiliSpec at Queen Elizabeth Central Hospital in Malawi, refining the design as necessary to incorporate user feedback and to meet design performance criteria. (3) Finally, working with a commercial partner, we will engineer a clinic-ready BiliSpec prototype for commercial manufacture.