HLS-Affordable, quantitative microchip-electrophoresis for sickle cell disease screening

HLS-用于镰状细胞病筛查的经济实惠的定量微芯片电泳

• 批准号: 9789452
• 负责人: PETER GALEN
• 金额: $ 75万
• 依托单位: HEMEX HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-12 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9789452
• 关键词: Acetates; Address; Adult; Affect; Africa; Age; American; Area; Blood; Capillary Electrophoresis; Cellulose; Child; Clinical; Collection; Computer software; Country; Development; Devices; Diagnosis; Diagnostic Procedure; Disease; Early Diagnosis; Economically Deprived Population; Electrophoresis; Ensure; Environment; Fingers; Glucose; Goals; Gold; Health Personnel; Heel; Hemoglobin; Hemoglobin C Disease; High Pressure Liquid Chromatography; Human Resources; India; Laboratories; Longevity; Low income; Microchip Electrophoresis; Monitor; Patients; Performance; Phase; Positioning Attribute; Preparation; Price; Reader; Resources; Sampling; Sensitivity and Specificity; Sickle Cell; Sickle Cell Anemia; Sickle Hemoglobin; Small Business Innovation Research Grant; Step Tests; Technology; Testing; Thalassemia; Time; Translating; United States; Validation; Variant; Work; World Health Organization; accurate diagnosis; commercialization; cost; cost effective; design; diagnostic accuracy; disadvantaged population; effective therapy; fetal; field study; laboratory equipment; miniaturize; point of care; point-of-care diagnostics; portability; prototype; research clinical testing; screening; screening program; sickling

PROJECT SUMMARY Sickle Cell Disease (SCD) affects 100,000 Americans and more than 14 million people globally, primarily in economically disadvantaged populations. It is estimated that nearly 50-90% of children born with SCD in these areas die before the age of five, although 70% could be saved through simple, cost-effective treatments if diagnosed early according to World Health Organization. Early diagnosis of SCD remains a challenge in the developing world due to requirements for sophisticated lab equipment and skilled personnel; therefore, an affordable, accurate point-of- care (POC) diagnostic is needed. Our device (“HemeChip”) provides the performance of a laboratory test in a product that is portable, affordable, rapid, and easy-to-use. “HemeChip” is a miniaturized version of the standard test used in SCD screening, known as cellulose acetate hemoglobin electrophoresis, which can identify SCD with high sensitivity and specificity, as well as identify and quantify the most common hemoglobin types – a feature that enables a more accurate diagnosis. The objective of this SBIR Phase I/II Fast-Track project is to translate HemeChip technology into a POC platform for diagnosing hemoglobin disorders, specifically SCD. In Phase I, we propose to demonstrate hemoglobin variant identification and quantification performance against quantitiative capillary electrophoresis and/or high performance liquid chromatography, which are considered to be the gold standard tests. Our Phase II aims and milestones focus on activities required for commercialization: single-use cartridge (finger/heel- stick) development, design validation and clinical testing, which will position the technology for regulatory filings. Our goal is to ensure that HemeChip technology addresses the requirements for a low-cost, easy-to-use, POC screening platform for SCD in low-income and under-resourced environments. Our proposed device will address a major gap in regions where universal sickle cell screening programs are missing or ineffective in reaching remote areas. The portable design, affordability, rapid and accurate testing makes it practical, for the first time, to effectively screen large numbers of people with sickle cell disease and other hemoglobin variants in Africa and India.

项目总结 镰状细胞病(SCD)影响着10万美国人和全球1400多万人， 主要是在经济困难人群中。据估计，近50%-90%的儿童 这些地区出生时患有SCD的人在5岁之前就会死亡，尽管70%的人可以通过 根据世界卫生组织的说法，如果及早诊断，简单、成本效益高的治疗方法。早些时候 SCD的诊断在发展中国家仍然是一项挑战，因为对 先进的实验室设备和熟练的人员；因此，一个负担得起的、准确的 需要关怀(POC)诊断。我们的设备(“血芯片”)提供了 对便携、实惠、快速、易用的产品进行实验室测试。“血芯片”是一部 SCD筛查中使用的标准测试的微型版本，称为醋酸纤维素 血红蛋白电泳法检测SCD具有较高的敏感性和特异性 AS识别和量化最常见的血红蛋白类型-这一特征使 准确的诊断。SBIR第一阶段/第二阶段快速通道项目的目标是翻译 将血液芯片技术整合到用于诊断血红蛋白疾病的POC平台，特别是 SCD。在第一阶段，我们建议演示血红蛋白变体的识别和量化。 抗定量毛细管电泳液和/或高效液体的性能 层析，这被认为是金标准的测试。我们的第二阶段目标和 里程碑侧重于商业化所需的活动：一次性墨盒(手指/脚后跟- Stick)开发、设计验证和临床测试，这将使技术定位于 监管备案文件。我们的目标是确保血液芯片技术满足需求 为低收入和资源不足地区的SCD提供低成本、易用的POC筛查平台 环境。我们建议的设备将解决普遍使用镰刀的地区的一个主要缺口 在偏远地区，细胞筛查计划缺失或无效。轻便的设计， 可负担性、快速和准确的检测首次使有效筛查变得切实可行 在非洲和印度，大量患有镰状细胞病和其他血红蛋白变异体的人。