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

• 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
• 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

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）：镰状细胞病（SCD）和其他血红蛋白病的新生儿筛查已被证明可以通过早期干预降低受影响个体的发病率和死亡率，并减轻这类常见疾病的医疗负担。然而，传统的筛查方法费力且成本高昂，因此通常不适合 SCD 高发地区的资源匮乏地区。我们建议开发一种快速、简单且廉价的侧流免疫分析 (LFIA) 检测试剂盒，用于直接在全血样本中即时检测血红蛋白表型。这种方便且廉价的检测形式已被证明是一种准确可靠的诊断方法，适用于需要快速检测的各种 POC 应用。拟议的血红蛋白表型 LFIA 将利用针对 HbA、HbS 和 HbC 的高度特异性单克隆抗体 (MAb)，该抗体是 Silver Lake Research 最近使用专有抗体生成系统开发的。通过在单次测试中使用这些 MAb，拟议的 LFIA 将能够识别和区分最常见的 SCD 表型，包括正常 (HbAA)、HbSS、HbAS、HbCC、HbSC 和 HbS/boThal。所提出的测试套件还将包括廉价的一次性样品制备组件，能够快速制备全血样品或干血斑过滤器以供 LFIA 测试条分析。 SLRC 现有的 LFIA 格式用于该公司目前制造的测试，共享一个低成本生产平台，能够以每单位 <2 美元的价格向最终用户提供测试。 SLRC 在 LFIA 开发和生产方面拥有超过 15 年的经验，最初设计、开发和制造的 20 多种市售 LFIA 产品。

项目成果

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。

• DOI: 10.1111/bjh.14298
• 发表时间: 2016-11
• 期刊: British journal of haematology
• 影响因子: 6.5
• 作者: Quinn CT;Paniagua MC;DiNello RK;Panchal A;Geisberg M
• 通讯作者: Geisberg M