Rapid LFIA blood test for SCD using highly specific monoclonal antibodies

描述（由申请人提供）：新生儿镰状细胞病（SCD）和其他血红蛋白病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，并减轻这一常见疾病组的医疗负担。然而，传统的筛查方法既费力又昂贵，因此通常不适用于SCD高患病率地区的低资源环境。我们建议开发一种快速、简单、廉价的横向流动免疫测定（LFIA）检测试剂盒，用于直接在全血样本中检测血红蛋白表型。这种方便和廉价的检测格式已被证明是一种准确可靠的诊断方法，适用于各种需要快速检测的POC应用。提议的血红蛋白表型LFIA将利用针对HbA、HbS和HbC的高特异性单克隆抗体（mab），这些抗体最近由银湖研究公司（Silver Lake Research）使用专有抗体生成系统开发。通过在单个测试中使用这些单克隆抗体，所提出的LFIA将能够识别和区分最常见的SCD表型，包括正常（HbAA）、HbSS、HbAS、HbCC、HbSC和HbS/boThal。建议的检测试剂盒还将包括一个廉价的一次性样品制备组件，能够快速制备全血样本或干血斑过滤器，用于LFIA测试条的分析。SLRC现有的LFIA格式，用于该公司目前生产的测试，共享一个低成本的生产平台，将能够以每单位< 2美元的价格向最终用户交付测试。SLRC在LFIA开发和生产方面拥有超过15年的经验，其中有20多种LFIA产品最初是由SLRC设计，开发和制造的。

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.