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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要镰状细胞病 (SCD) 影响着 10 万美国人和全球超过 1,400 万人，据估计，主要是经济弱势群体中的近 50-90% 的儿童。这些地区出生时患有 SCD 的人会在五岁之前死亡，尽管 70% 的人可以通过以下方式获救根据世界卫生组织的说法，如果早期诊断，则可以进行简单且具有成本效益的治疗。由于对 SCD 的要求，SCD 的诊断在发展中国家仍然是一个挑战先进的实验室设备和熟练的人员；因此，一个负担得起的、准确的点需要护理（POC）诊断，我们的设备（“HemeChip”）提供了一个性能。 “HemeChip”是一款便携式、价格实惠、快速且易于使用的实验室测试产品。 SCD 筛选中使用的标准测试的小型化版本，称为醋酸纤维素血红蛋白电泳，可以高灵敏度和特异性地识别 SCD 作为识别和量化最常见的血红蛋白类型 - 这一功能可以使更多 SBIR I/II 期快速通道项目的目标是转化准确的诊断。 HemeChip 技术融入 POC 平台，用于诊断血红蛋白疾病，特别是在第一阶段，我们建议展示血红蛋白变异的识别和定量。定量毛细管电泳和/或高性能液体的性能色谱法，这被认为是我们第二阶段的目标和金标准测试。里程碑重点关注商业化所需的活动：一次性墨盒（手指/脚后跟） Stick）开发、设计验证和临床测试，这将使该技术定位于我们的目标是确保 HemeChip 技术满足要求。为低收入和资源贫乏地区的 SCD 提供低成本、易于使用的 POC 筛查平台我们提出的设备将解决通用镰刀地区的主要差距。细胞筛查程序在到达偏远地区时缺失或无效，经济实惠、快速准确的测试首次使有效筛查变得可行非洲和印度有大量患有镰状细胞病和其他血红蛋白变异的人。