Validation of a Low-Cost, Point-of-Care Bilirubin Measurement to Diagnose Neonatal Jaundice and Monitor Phototherapy in Hospitals in Sub-Saharan Africa
William Marsh Rice University
Summary
A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BiliSpec, a low-cost battery-powered reader designed to immediately quantify serum bilirubin levels from a small drop of whole blood applied to a lateral flow strip. 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. The goal of this study is to validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to the laboratory spectrophotometric bilirubinometer and transcutaneous bilirubinometer measurements.
Description
This study will validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to a laboratory spectrophotometric bilirubinometer (Reichert UNISTAT® Bilirubinometer) and transcutaneous bilirubinometer measurements. This study will enroll up to 500 neonates at Queen Elizabeth Central Hospital and Kamuzu Central Hospital each, for a total of up to 1000 neonates, at risk for jaundice based on clinical signs and symptoms or undergoing phototherapy for treatment of jaundice. During the pilot study, 100 participants were evaluated and 147 samples total were collecte…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The patient is currently being treated at Queen Elizabeth Central Hospital or Kamuzu Central Hospital in the neonatal ward. * The patient is less than 28 days old (neonate). * The patient is deemed to be at risk for jaundice or the patient is undergoing blue light phototherapy for treatment of jaundice. * The patient's parent or guardian has provided informed consent for their child to participate. Exclusion Criteria: * Parent or guardian is unable or unwilling to provide informed consent. * The patient is unable to receive a blood draw/heel stick as determined by thei…
Interventions
- Diagnostic TestBiliSpec
BiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample.
Locations (3)
- Rice UniversityHouston, Texas
- Queen Elizabeth Central HospitalBlantyre
- Kamuzu Central HospitalLilongwe