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.
Identification and counseling of beta-thalassemia carriers has been proven to reduce disease incidence by >90%, but implementation is hampered by the cost and logistics of population-based screening. This proposal aims to develop an accurate, simple, and inexpensive test for determination of beta-thalassemia carrier status, usable worldwide.
