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: 9913568
• 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 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9913568
• 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.

项目摘要 镰状细胞疾病（SCD）影响了100,000名美国人，全球超过1400万， 主要是在经济上处于不利地位的人群。 Althooth 70％可能是在该地区生于该地区的SCD死亡，可以节省 简单，具有成本效益的治疗方法，如果早期被诊断出 由于要求 精致的实验室设备和熟练的人员； 需要诊断（POC）。 “ hemehip”是一个。 用于筛选的标准测试的小型化版本，称为醋酸纤维素 血红蛋白电泳也可以识别具有高灵敏度和特异性的SCD 作为识别并量化最常见的血红蛋白类型 - 一种功能，可以使更多 准确的诊断。 临时技术进入POC平台，以诊断血红蛋白障碍，特别是 SCD。 针对定量毛细管电泳和 /或高性能液体的性能 色谱：我们的II阶段目标被认为是金标准的。 里程碑专注于商业化所需的活动：一次性墨盒（手指/脚跟 - Stick）开发，设计验证和临床测试，这将定位 监管申请。 用于低收入Ander Resourced中SCD的宽松成本，易于使用的POC筛选平台 环境。 细胞筛选程序缺少或无效到达偏远地区。 负担能力，快速准确的测试使其首次实用到有效的屏幕 非洲和印度的大量患有镰状细胞疾病和其他血红蛋白变体的人。