A Novel E-Junction Lateral Flow Immunoassay for Widespread Sickle Cell Screening in Low and Middle-Income Countries

Abstract

Sickle cell disease (SCD) affects more than 250 million people globally. The life-threatening, inherited blood disorder results in sickled red blood cells, which can become trapped in blood vessels, causing anemia, pain, organ damage, increased risk for infection and reduced life expectancy. SCD is especially common in sub-Saharan Africa where the mortality rate among children is estimated to be 50-90%. However, universal screening paired with early intervention programs have proven to be effective in reducing the mortality rate of SCD in high-income countries. Diagnostic methods utilized in high-income countries are expensive and resource heavy, inhibiting widespread implementation in low and middle-income countries (LMIC). In order to address this need, a low-cost, point-of-care lateral flow device, designed to be implemented in LMICs has been developed. Recent efforts have been focused on the optimization of the biofunctionalization of the lateral flow device and determining the device’s dynamic range. The device consists of a direct binding immunoassay that can function with a single drop of whole blood and is able to diagnose healthy blood, SCD, and sickle cell trait (SCT) individuals. The novel E-junction device design meets the affordability, usability, and reliability demands of a sickle cell screening device for implementation in LMICs.