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

描述（由申请人提供）：该I期SBIR提案描述了用于诊断镰状细胞病和护理点特征的电动侧流试验（eLFT）的发展。这项技术将被开发用于低资源环境，在这些环境中，长期目标是实施低成本的新生儿筛查项目，可以对预防儿童死亡率产生直接影响——撒哈拉以南非洲出生时患有SCD的儿童死亡率高达50-90%。镰状细胞病eLFT技术基于新一代横向流量测试平台的专利三明治免疫分析格式，该平台由低功率电池驱动，可用于便携式和快速检测。该测试将导致高特异性检测成人血红蛋白（HbA），镰状血红蛋白（HbS），或两者的组合从全血；提供一个简单的读数，对应于患者镰状细胞病阴性（仅检测HbA）、镰状细胞病阳性（仅检测HbS）或镰状细胞特征阳性（检测HbA和HbS）。在开发eLFT诊断过程中，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微流控芯片设计和检测方案，3)开发便携式芯片读取器，4)测试最终设备的诊断敏感性和特异性。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（二期）提供信息，以确保eLFT设备适用于包括发展中国家诊所在内的资源匮乏环境中的护理点操作。

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.