Electrokinetic Lateral Flow Tests for Rapid Point-of-Care Diagnosis of Sickle Cel

描述（由申请人提供）：本I期SBIR提案描述了用于在护理点诊断镰状细胞病和特征的电动侧向流试验（eLFT）的开发。这项技术将被开发用于低资源环境，长期目标是实施低成本的新生儿筛查计划，可以对预防儿童死亡产生直接影响-撒哈拉以南非洲出生的SCD儿童死亡率高达50-90%。镰状细胞病eLFT技术基于下一代侧流测试平台上的专利夹心免疫测定格式，由低功耗电池驱动，可进行便携式快速检测。该测试将导致成人血红蛋白（HbA）、镰状血红蛋白（HbS）或全血中两者的组合的高特异性检测;提供对应于镰状细胞病阴性（仅检测HbA）、镰状细胞病阳性（仅检测HbS）或镰状细胞性状阳性（检测HbA和HbS）的患者的简单读数。在eLFT诊断的开发过程中将实现以下具体目标：1）生产和筛选区分HbA和HbS的高质量单克隆抗体，2）优化核心eLFT微流控芯片设计和测定方案，3）开发便携式芯片读取器，4）并测试最终设备的诊断灵敏度和特异性。与加纳镰状细胞基金会的合作将为设计和未来的临床测试要求（第二阶段）提供信息，以确保eLFT设备适用于低资源环境（包括发展中国家的诊所）的护理点操作。

DESCRIPTION (provided by applicant): This phase I SBIR proposal describes the development of an electrokinetic lateral flow test (eLFT) for diagnosing sickle cell disease and trait at the point-of-care. This technology will be developed to work in low resource settings where the long-term goal is implementing low-cost neo-natal screening programs that can have an immediate impact on preventing childhood mortality-which reaches upwards of 50-90% for children born with SCD in sub-Saharan Africa. The sickle cell disease eLFT technology is based on a patented sandwich immunoassay format on a next-generation lateral flow test platform actuated by a low power battery for portable and rapid detection. The test will result in high specificity detection of adult hemoglobin (HbA), sickle hemoglobin (HbS), or a combination of the two from whole blood; providing a simple readout corresponding to the patient being negative for sickle cell disease (detect HbA only), positive for sickle cell disease (detect HbS only), or positive for sickle cell trait (detect HbA and HbS). The following specific aims will be achieved during the development of the eLFT diagnostic: 1) production and screening of high quality monoclonal antibodies differentiating HbA from HbS, 2) optimization of the core eLFT microfluidic chip design and assay protocol, 3) development of a portable chip reader, 4) and testing of diagnostic sensitivity and specificity of the final device. Collaboration with the Sickl Cell Foundation of Ghana will inform design and future clinical testing requirements (Phase II) to ensure that the eLFT device is suitable for point-of-care operation in low resource settings including clinics in the developing world.