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

针对β地中海贫血携带者的快速且廉价的护理点检测

基本信息

批准号：
10053692
负责人：
MARK GEISBERG
金额：
$ 34.85万
依托单位：
SILVER LAKE RESEARCH CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-15 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10053692
关键词：
Adult Africa Alleles Amino Acids Area Bedside Testings Biological Assay Biological Markers Blood specimen Calibration Collection Consultations Counseling Detection Development Diagnosis Disease Education Enzyme-Linked Immunosorbent Assay Genetic Genetic Diseases Hemoglobin Hemoglobin A2 Hemoglobin E Hemoglobinopathies Home environment Immunoassay Incidence India Instruction Intervention Laboratories Lateral Link Logistics Methodology Methods Middle East Monoclonal Antibodies Mutation Newborn Infant Performance Phenotype Population Pregnancy Tests Production Protocols documentation Reporting Research Sampling Sickle Cell Anemia Silver Southeastern Asia Testing Validation Variant Whole Blood Work base beta Thalassemia carrier status carrier testing cost design experience point of care population based pre-clinical programs prototype quality assurance screening

项目摘要

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.

项目摘要/摘要本提案描述了HemoTypeBT的发展，一种快速而廉价的用于鉴定β-地中海贫血携带者的护理点免疫分析试剂盒。针对携带者的筛查和咨询计划已被证明在减少这种遗传病的发病率高达90%。然而，成本和物流负担今天的测试方法是实施这类计划的一个很高的障碍。这个拟议的检测试剂盒将是横向流动免疫分析，原则上类似于家庭妊娠测试，并基于非常成功的镰状细胞血型SC测试疾病。该测试设计是基于针对与疾病相关的血红蛋白变种之间的微小差异。在成功的拟议工作的结论是，HemoTypeBT检测试剂盒将进行临床前验证并准备好制造并提交监管机构审批全世界。