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/摘要该提案描述了healotypebt的发展，这是一种快速且廉价的用于鉴定β-甲性贫血携带者的即时护理免疫测定测试套件。针对运营商的筛查和咨询计划已被证明有效减少这种遗传疾病的发生率> 90％。但是，成本和后勤负担今天的测试方法是实施此类程序的高障碍。这拟议的测试套件将是横向流量免疫测定，原则上类似于房屋妊娠试验，并基于非常成功的镰状细胞血体测试疾病。测试设计基于特定于该抗体（mAb）疾病连接的血红蛋白变体之间的微小差异。在成功拟议工作的结论，炎症性BT测试套件将经过临时验证并准备好制造和提交法规机构的批准全世界。