Development and Application of a Point-of-Care Assay for Plasma Bilirubin

Organization: 
BILIMETRIX SRL
Organization Location: 
Trieste, Italy

Devastating brain injury and neonatal death caused by hyperbilirubinemia (kernicterus) is very common in low resource settings (LRS) but can be prevented by early detection and treatment with light therapy. A major roadblock to the global effort to eliminate kernicterus is the inability to measure total plasma bilirubin (TB) in most LRS, including many referral hospital centers. To meet this need, we are developing an inexpensive POC system that rapidly measures TB. A small drop of blood (ca. 25 µl) is applied to a test strip, plasma is filtered and passed to a paper membrane, and TB, measured using a hand-held reflectometer, is reported in 60-100 seconds. No reagents are required. Comparison of TB in patients measured simultaneously by clinical laboratories and our prototype “Bilistick” system yielded a Pearson correlation of 0.96 with TB ranging from 1.5 to 29.8 mg/dL. SL@B support will secure final configurations of readers and test strips, validate their accuracy, and produce sufficient numbers of readers and test strips to initiate and evaluate pilot programs in Nigeria, Egypt, and Indonesia that screen infants for hyperbilirubinemia and monitor their treatment. We identified a major neglected problem (kernicterus) in LRS, analyzed its core causes (medical training, public awareness, no evaluation of jaundice, delayed referral for care), and will provide a critical missing component in the battle to eliminate kernicterus (a low cost POC system that can measure TB over a wide concentration range).

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