权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Rapid LFIA blood test for SCD using highly specific monoclonal antibodies

使用高度特异性单克隆抗体对 SCD 进行快速 LFIA 血液检测

基本信息

批准号：
9170967
负责人：
MARK GEISBERG
金额：
$ 50万
依托单位：
SILVER LAKE RESEARCH CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-08-01 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9170967
关键词：
Adult Affect Amino Acids Area Awareness Bedside Testings Biological Assay Blood Blood Tests Blood Volume Blood specimen Brazil Clinical Clinical Research Collaborations Communities Consultations Data Detection Developing Countries Development Diagnosis Diagnostic tests Disease Early Intervention Early treatment Environment Head Healthcare Hematology Hemoglobin High Prevalence Home environment Immunoassay Individual Intervention Laboratories Lateral Life Marketing Medical Methods Monoclonal Antibodies Morbidity - disease rate Mutation Neonatal Screening Patient-Focused Outcomes Performance Phase Phenotype Population Postdoctoral Fellow Pregnancy Tests Preparation Price Procedures Production Reporting Research Design Research Personnel Resources Sampling Sickle Cell Anemia Spottings Technology Temperature Test Result Testing Time Translational Research Universities Validation Variant Whole Blood Work base carrier status cost design disease phenotype effective therapy experience hemoglobin AA improved instrument mid-career faculty mortality pediatric department point-of-care diagnostics pre-clinical prevent professor programs prototype screening social trait treatment center trial design validation studies

项目摘要

PROJECT SUMMARY/ABSTRACT This proposal describes Phase II of the development of a rapid immunoassay test kit for the determination of hemoglobin variants in blood, to be used as a point-of-care diagnostic test for sickle cell disease (SCD) and SCD carrier trait in low-resource settings worldwide. Today, determination of SCD and SCD trait requires lengthy and expensive laboratory analyses that are not available in low-resource settings, and >80% of individuals with SCD and SCD trait live in areas where healthcare is provided in those settings. Nevertheless, newborn screening programs have resulted in significant improvement of patient outcomes due to early treatment to prevent complications of the disease. The proposed test kit will be a lateral flow immunoassay, similar in principle to a home pregnancy test. The test design is based on monoclonal antibodies (MAbs) specific for the single-amino-acid differences between SCD-related hemoglobin variants. In Phase I, the applicant developed a working prototype hemotyping test kit which was shown to correctly identify the phenotype of >99% of tested whole blood samples, including each relevant SCD and carrier phenotype. The prototype test requires a 1-microliter volume of blood and the time-to-result is under 20 minutes. In Phase II, the test kit will be further improved and simplified, and a complete manufacturable product will be developed. Clinical validation studies will be carried out to determine the real-world performance of the product, including studies performed in low-resource settings in Brazil. At the successful conclusion of Phase II, the test kit will be ready for manufacturing and submission for approval to regulatory agencies worldwide. The estimated cost of the hemotyping test kit will be $2.00, a price point that will allow widespread acceptance of this test kit in developing countries.

项目总结/文摘