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：
8902261
负责人：
MARK GEISBERG
金额：
$ 22.15万
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 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8902261
关键词：
Address Affect Affinity Amino Acids Antibodies Area Binding Biological Assay Blood Blood Tests Blood specimen Buffers Clinical Research Collection Consultations Data Data Set Detection Development Diagnostic Disease Early Intervention Environment Generations Health Personnel Healthcare Hematology Hemoglobin Hemoglobinopathies High Prevalence Immunoassay Individual Intervention Lateral Marketing Methodology Methods Monoclonal Antibodies Morbidity - disease rate Neonatal Screening Outcome Patients Performance Phase Phenotype Postdoctoral Fellow Preparation Process Production Proteins Reporting Research Research Design Resources Sampling Sensitivity and Specificity Sickle Cell Anemia Silver Solutions Spottings System Temperature Testing Translational Research Universities Validation Whole Blood Work abstracting base color detection cost design disease diagnosis disease phenotype experience hemoglobin AA improved mortality mutant novel pediatric department point of care pre-clinical professor prototype public health relevance screening

项目摘要

DESCRIPTION (provided by applicant): Neonatal screening for sickle cell disease (SCD) and other hemoglobinopathies has been shown to reduce morbidity and mortality of affected individuals through early intervention, and to also reduce the healthcare burden of this common group of disorders. However, traditional screening methods are laborious and costly, and thereby often inappropriate for low-resource settings in areas of high prevalence of SCD. We propose the development of a rapid, simple, and inexpensive lateral-flow immunoassay (LFIA) test kit for the point-of-care detection of hemoglobin phenotypes directly in whole blood samples. This convenient and inexpensive assay format has proven to be an accurate and reliable diagnostic methodology for a variety of POC applications where a rapid assay is needed. The proposed LFIA for hemoglobin phenotypes will utilize highly specific monoclonal antibodies (MAbs) for HbA, HbS, and HbC, recently developed by Silver Lake Research using a proprietary antibody generation system. By using these MAbs in a single test, the proposed LFIA will be able to identify and distinguish between the most common SCD phenotypes including normal (HbAA), HbSS, HbAS, HbCC, HbSC, and HbS/boThal. The proposed test kit will also include an inexpensive, disposable sample preparation component, capable of rapidly preparing a whole blood sample or dried blood spot filter for analysis by the LFIA test strip. SLRC's existing LFIA formats, used in tests currently manufactured by the Company, share a low-cost production platform that will enable the delivery of tests to the end-user at < $2 per unit. SLRC has over 15 years of experience in LFIA development and production, with more than 20 marketed LFIA products originally designed, developed, and manufactured at SLRC.

描述（由申请人提供）：已证明对镰状细胞病（SCD）和其他血红蛋白病的新生儿筛查可通过早期干预降低受影响个体的发病率和死亡率，并减轻这种常见疾病的医疗保健负担。但是，传统的筛查方法是费力且昂贵的，因此通常不适合SCD高流行的低资源环境。我们提出了一个快速，简单且廉价的侧向免疫测定法（LFIA）测试试剂盒，以直接在全血样品中检测血红蛋白表型的护理点。事实证明，这种方便且廉价的测定格式是需要快速测定的各种POC应用的准确诊断方法。拟议的用于血红蛋白表型的LFIA将利用Silver Lake Research使用专有抗体生成系统开发的HBA，HBS和HBC的高度特异性单克隆抗体（MAB）。通过在单个测试中使用这些MAB，提出的LFIA将能够识别和区分最常见的SCD表型，包括正常（HBAA），HBSS，HBAS，HBAS，HBCC，HBCC，HBSC和HBS/HBS/Bothal。拟议的测试套件还将包括廉价的一次性样品制备成分，能够快速制备全血样品或干燥的血液点过滤器，以通过LFIA测试条进行分析。 SLRC现有的LFIA格式（用于公司当前由公司生产的测试中）共享一个低成本生产平台，该平台将使测试能够以每单位<$ 2的价格向最终用户提供。 SLRC在LFIA开发和生产方面拥有超过15年的经验，其中20多种销售的LFIA产品最初在SLRC上设计，开发和生产。

项目成果

期刊论文数量（2）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Point-of-care screening for sickle cell disease in low-resource settings: A multi-center evaluation of HemoTypeSC, a novel rapid test.

DOI：
10.1002/ajh.25305
发表时间：
2019-01
期刊：
American journal of hematology
影响因子：
12.8
作者：
Steele C;Sinski A;Asibey J;Hardy-Dessources MD;Elana G;Brennan C;Odame I;Hoppe C;Geisberg M;Serrao E;Quinn CT
通讯作者：
Quinn CT

A rapid, inexpensive and disposable point-of-care blood test for sickle cell disease using novel, highly specific monoclonal antibodies.

使用新型、高度特异性的单克隆抗体进行快速、廉价且一次性的镰状细胞病即时血液检测。