Design for Manufacture and Validation of Disposable Strips for Low-cost, Point-of-Care Bilirubin Measurement to Diagnose Neonatal Jaundice and Monitor Phototherapy in Hospitals in Sub-Saharan Africa

University of Malawi College of Medicine
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Newborns are at increased risk of jaundice when excess bilirubin builds up in blood. If untreated, jaundice can result in neurological impairment and death. Although jaundice is easily treated with blue light and phototherapy systems have been developed for low-resource settings, there is no way to diagnose or monitor bilirubin in these settings. In response to this challenge, Rice University developed BiliSpec, which measures bilirubin concentration in a drop of blood. Early clinical studies indicate that BiliSpec is on track to meet CLIA standards, and Rice is currently conducting a validation study of the BiliSpec reader using Saving Lives at Birth funding. However, the reader’s disposable strips are currently hand-assembled and require significant revisions to improve usability and manufacturability before BiliSpec can transition to wide-scale implementation. The objectives of this project are to redesign the strips to validate their performance and set up a manufacturing line that is accessible to sub-Saharan Africa to allow BiliSpec to transition to scale. Estimates indicate that BiliSpec could prevent the deaths of approximately 40,000 newborns and disability in 265,000in sub-Saharan Africa who suffer every year due to lack of access to effective treatment and monitoring for neonatal jaundice in low-resource settings. .

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