Bilistick: A Low-Cost Point-of-Care System to Measure Total Plasma Bilirubin

Abstract

Background: Severe neonatal hyperbilirubinemia, with consequent encephalopathy, remains a common cause of morbidity and death in many regions of the world. Poor access to clinical laboratory resources and screening programs to measure plasma bilirubin levels is a major contributor to delayed treatment in developing countries, and the cost of existing point-of-care screening instruments precludes their dissemination. Objectives: We are evaluating the accuracy of a low-cost, minimally invasive point-of-care system (Bilistick) requiring a 25-µl blood sample that could be used in low-resource environments to evaluate patients with neonatal jaundice. Methods: We compared plasma bilirubin levels in divided blood samples by clinical laboratories and by Bilistick at two medical centers serving term and near-term newborns from ethnically different populations. Results: 118 neonates with bilirubin levels ranging from 24.8 to 501.0 µmol/l were analyzed. The mean bilirubin concentration (±SD) was 215.6 ± 85.5 µmol/l for Bilistick and 226.1 ± 86.4 µmol/l by laboratory determination. Pearson’s correlation coefficient between all paired results was 0.961, and the Bland-Altman analysis showed a mean difference of 10.3 µmol/l with a 95% interval of agreement of –38.0 to 58.7 µmol/l. Conclusion: Bilistick is a minimally invasive method for measuring total bilirubin concentration over a wide range of values and should provide an affordable and accurate system for pre-discharge and follow-up screening of jaundiced infants, particularly in low-resource environments.

Severe Neonatal Hyperbilirubinemia in the Netherlands

“…This may suggest that infants with more progressive hemolysis were born and remained in the hospital more often, and underwent ET earlier, or that SH was recognized later in infants born at home. A low-cost point of care system to measure bilirubin in blood or transcutaneously may help to recognize SH outside the hospital earlier [22]. …”

Neonatal Jaundice in Low- and Middle-Income Countries: Lessons and Future Directions from the 2015 Don Ostrow Trieste Yellow Retreat

“…Health facilities often face long delays for TSB results and in primary health care settings or remote areas, testing is usually unavailable. The Bilistick System (Bilimetrix S.R.L., Trieste, Italy) is a low-cost, point-of-care bilirubin assay able to provide early NNJ diagnosis by determining TSB concentration from a tiny drop of blood, and is currently in advanced testing [78]. If successful, it could fulfil the need for rapid results and predischarge screening in already-equipped facilities and for decentralized testing and referral to support visual assessments.…”

Why is kernicterus still a major cause of death and disability in low-income and middle-income countries?

“…This low-cost technology holds promise especially in tropical LMICs where the application of conventional phototherapy is constrained by costs and exogenous factors outside the control of the health system. Also promising is the emerging low-cost, minimally invasive, point-of-care tools for plasma/serum bilirubin monitoring 47. Pharmacotherapies, such as metalloporhyrins and clofibrate, also hold promise as potential low-cost treatments.…”