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

项目总结/摘要 该提案描述了HemoTypeBT的开发，一种快速且廉价的 用于鉴定β地中海贫血携带者的即时免疫测定试剂盒。 针对携带者的筛查和咨询计划已被证明有效地减少了 这种遗传病的发病率> 90%。然而，成本和后勤负担 当今的测试方法是实施这些计划的一个很高的障碍。的 拟议的检测试剂盒将是一个横向流动免疫测定，类似于家庭的原则， 妊娠测试，并基于非常成功的镰状细胞HemoTypeSC测试 疾病该试验设计基于特异性针对以下各项的单克隆抗体（MAb）： 与疾病相关的血红蛋白变体之间的微小差异。对成功 拟定工作结束后，将对HemoTypeBT检测试剂盒进行临床前确认 并准备生产和提交给监管机构批准 国际吧

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.