Validation of a Low-Cost, Point-of-Care Bilirubin Measurement to Diagnose Neonatal Jaundice and Monitor Phototherapy in Hospitals in Sub-Saharan Africa

Organization: 
William Marsh Rice University
Organization Location: 
Houston, Texas, USA
Project Location: 
Malawi

Newborns are at increased risk of jaundice when excess bilirubin builds up in blood. Lack of treatment leads to neurological impairment and death. Fortunately, jaundice is easily treated with blue light, and phototherapy systems have been developed for low-resource settings; however, there are no appropriate solutions to diagnose and monitor bilirubin in these settings. This project’s approach is BiliSpec, which measures bilirubin concentration in a drop of blood. Early clinical studies show BiliSpec is on track to meet CLIA standards. The objectives are to optimize the system, perform a large-scale trial to compare its accuracy to laboratory standards, develop manufacturing capacity in Malawi for the strips to encourage long-term sustainability, and develop a plan to support wide-scale, sustainable implementation of BiliSpec in hospitals across the country. The Rice University team estimates the device could prevent the deaths of approximately 90,000 neonates who die every year due to lack of access to effective treatment and monitoring for neonatal jaundice in low-resource settings. 

Currently, low-resource settings rely on clinical diagnosis of jaundice because existing bilirubinometers are too expensive. Clinical diagnosis is subjective and accuracy is poor. BiliSpec’s $0.05 lateral flow device quickly separates plasma from whole blood, and the battery-powered reader accurately measures light transmission through the plasma to report the bilirubin concentration.

See video