BILISPEC BILIRUBIN MEASUREMENT DEVICE

 

Global Health Challenge:

 

Neonatal jaundice affects approximately 24 million newborns each year.  Jaundice is especially common in premature babies and, if left untreated, can result in severe, untreatable brain damage.  Severe jaundice may not present until several days after birth, thus early monitoring of serum bilirubin levels is critical.  In high-resource settings, tools to measure serum bilirubin levels are readily available, but have proven too expensive and complex to implement widely in low-resource settings. As a result, jaundice is diagnosed clinically in most low-resource settings using visual inspection of scleral yellowing, resulting in subjective diagnosis and poor accuracy. 

 

Rice 360° Solution:

 

BiliSpec is a low-cost battery-powered reader designed to immediately measure serum bilirubin levels from a small drop of whole blood applied to an inexpensive, disposable lateral flow strip. A clinician will spot a drop of whole blood from a heel prick onto the strip and the battery powered reader displays a digital report of the bilirubin concentration by measuring the light transmitted through the serum on the detection strip. We estimate that the reader can be manufactured at low volume for less than $100 and that the per-test cost of the lateral flow strip will be less than $0.10. Our preliminary results indicate that results are available within 30 seconds. The simple and affordable BiliSpec system offers a faster and more cost-effective means to detect neonatal jaundice in under-resourced clinics and determine when phototherapy is needed. BiliSpec provides an important tool to monitor the efficacy and progress of phototherapy, ensuring appropriate treatment dosage and duration.  Used together, BiliSpec and blue light phototherapy have the potential to reduce the morbidity and mortality associated with neonatal jaundice. 

 

Current Status and Next Steps:

 

BiliSpec recently received a USAID Saving Lives at Birth seed grant to optimize, validate, test and begin scale up. Through this award we will complete the design and laboratory validation of BiliSpec. We will then partner with clinicians at Queen Elizabeth Central Hospital in Blantyre to test the accuracy of BiliSpec in a pilot clinical study. Following testing, we will engineer the device for commercial manufacture and develop plans to implement BiliSpec at district hospitals throughout the country. We believe that rapid adoption of this technology is possible since BiliSpec is affordable and simple to use at the bedside.  At the USAID Development Exchange, BiliSpec also received the Peer Choice Award!