A Rapid and Inexpensive Point-of-Care Test for Beta-Thalassemia Carriers

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PROJECT SUMMARY/ABSTRACT This proposal describes the development of HemoTypeBT, a rapid and inexpensive point-of-care immunoassay test kit for the identification of beta-thalassemia carriers. Screening and counseling programs aimed at carriers have proven effective in reducing the incidence of this genetic disease by >90%. However, the cost and logistical burden of today's testing methods is a high barrier to implementation of such programs. The proposed test kit will be a lateral flow immunoassay, similar in principle to a home pregnancy test, and based on the highly successful HemoTypeSC test for sickle-cell disease. The test design is based on monoclonal antibodies (MAbs) specific for the small differences between disease-linked hemoglobin variants. At the successful conclusion of the proposed work, the HemoTypeBT test kit will be pre-clinically validated and ready for manufacturing and submission for approval to regulatory agencies worldwide.