Portable, affordable, quantitative microchip electrophoresis for hemoglobin A1C testing

用于血红蛋白 A1C 测试的便携式、经济实惠的定量微芯片电泳

基本信息

批准号：
10656550
负责人：
PETER GALEN
金额：
$ 86.52万
依托单位：
HEMEX HEALTH, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-20 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10656550
关键词：
Africa Algorithms Anemia Antibodies Area Biological Assay Biological Markers Buffers Certification Cessation of life Clinical Clinical Research Country Coupled Detection Developing Countries Development Devices Diabetes Mellitus Diagnosis Diagnostic Diagnostic tests Disease Electrodes Ensure Family Feedback Fingers Ghana Glycosylated Hemoglobin Glycosylated hemoglobin A Government Guidelines Health Health Personnel Health Status Hemoglobin Hemoglobinopathies High Pressure Liquid Chromatography Home Image India Injections Label Laboratories Location Medical Staff Methods Microchip Electrophoresis Molds Monitor Morbidity - disease rate Names Patients Performance Persons Phase Prediabetes syndrome Prevalence Primary Health Care Procedures Reader Resources Running Sample Size Sampling Sickle Cell Anemia Site Small Business Technology Transfer Research Southeastern Asia Specific qualifier value Standardization Surface System Technology Test Result Testing Time Training United States Update Validation Variant World Health Organization beta Thalassemia blood glucose regulation clinical research site commercialization commercialization readiness cost design diabetes management diabetic diagnostic accuracy fasting plasma glucose field study improved improved outcome innovation low and middle-income countries mortality non-diabetic novel strategies performance tests point of care point of care testing portability programs prototype research clinical testing screening success underserved area validation studies

项目摘要

PROJECT SUMMARY Diabetes is one of the most important health issues in the world. The number of people living with diabetes has quadrupled since 1980, with the greatest increase in prevalence in low and middle-income countries. Not only is diabetes a major cause of morbidity and mortality, but it can also devastate the finances of families and strain countries’ financial resources. World Health Organization is challenging governments to achieve a 25% reduction in deaths by diabetes and other non-communicable diseases by 2025. A key part of the WHO program calls for improved diagnosis and management of diabetes in primary healthcare. For many years, the hemoglobin A1C test has been used as a reliable marker for diabetes and prediabetes, since it is the best indicator of glucose control over time. Due to the relative ease of testing of A1C versus the fasting plasma glucose test, it is often the preferred option in developing countries. Current A1C tests, however, may be inaccurate due to hemoglobinopathies, and their availability has been limited. Although monitoring of A1C in diabetics improves outcomes, current testing options are: (a) expensive laboratory tests with delayed results, (b) expensive point- of-care (POC) options not suitable for remote areas, or (c) expensive and hard-to-use home monitoring kits. We have developed a POC microchip electrophoresis system that accurately identifies and quantifies hemoglobin variants, HemeChip. This system is commercialized under the product name “Gazelle™” by Hemex Health Inc. It has been extensively validated in the US, Africa, India, and South-East Asia, with a focus on sickle cell disease and beta thalassemia. Gazelle is currently selling in 13 countries with more locations planned. In the STTR Phase I project, we successfully completed two milestones by developing (1) an easy-to-use modified functional HemeChip prototype design for glycosylated hemoglobin HbA1, and (2) a quantification algorithm to detect and quantify the relative percentages of the HbA1 and non-glycosylated hemoglobin. In this STTR phase II project we plan to: (1) develop a new approach to detect the HbA1C component within the HbA1 band which incorporates the total glycosylated hemoglobin components to comply with the National Glycohemoglobin Standardization Program (NGSP) diagnostic standard, (2) fully implement the modified design of the test cartridge into the Gazelle platform and adapt the system for use at the POC by entry level healthcare workers, and (3) clinically validate the performance of the HemeChip A1C assay. Specific aims are: Aim 1: To complete the development of a test cartridge and modify the Gazelle reader to support the A1C detection and quantification. Aim 2: To demonstrate diagnostic accuracy of the HemeChip A1C test by performing a pre-certification trial according to NGSP guidelines. Aim 3: To perform clinical testing and validation in the United States and Ghana. With its ease-of-use and affordability, the proposed POC A1C test will offer a solution that meets the needs of the developing world and other underserved regions.

项目概要糖尿病是世界上最重要的健康问题之一，糖尿病患者的数量已经增加。自 1980 年以来翻了两番，其中低收入和中等收入国家的患病率增幅最大。糖尿病是发病和死亡的主要原因，但它也会破坏家庭的财务状况并造成压力世界卫生组织正在向各国政府提出挑战，要求其实现 25% 的削减。到 2025 年，糖尿病和其他非传染性疾病导致的死亡人数将增加。世卫组织规划的一个关键部分呼吁：多年来，血红蛋白 A1C 改善了初级医疗保健中糖尿病的诊断和管理。测试已被用作糖尿病和糖尿病前期的可靠标志，因为它是血糖的最佳指标由于 A1C 测试相对于空腹血糖测试相对容易，因此它通常是最重要的。然而，由于以下原因，当前的 A1C 测试可能不准确。尽管糖尿病患者的 A1C 监测有所改善，但其可用性仍然有限。目前的测试选项是：（a）昂贵的实验室测试且结果延迟，（b）昂贵的点测试不适合偏远地区的护理 (POC) 选项，或 (c) 昂贵且难以使用的家庭监控套件。开发了 POC 微芯片电泳系统，可准确识别和量化血红蛋白变体，HemeChip。该系统由 Hemex Health Inc. 以产品名称“Gazelle™”进行商业化。它已在美国、非洲、印度和东南亚得到广泛验证，重点关注镰状细胞病和 β 地中海贫血目前在 13 个国家/地区销售，并计划在更多国家/地区销售。在 STTR 第一阶段项目中，我们通过开发 (1) 一个易于使用的产品成功完成了两个里程碑针对糖化血红蛋白 HbA1 的改良功能 HemeChip 原型设计，以及 (2) 定量算法检测和量化 HbA1 和非糖基化血红蛋白的相对百分比。在这个 STTR II 期项目中，我们计划：(1) 开发一种新方法来检测 HbA1C 成分 HbA1 带包含总糖化血红蛋白成分，符合国家标准糖化血红蛋白标准化计划（NGSP）诊断标准，（2）全面实施修改设计将测试盒导入 Gazelle 平台，并调整系统以供入门级医疗保健在 POC 中使用 (3) 临床验证 HemeChip A1C 检测的性能。具体目标是：目标 1：完成测试盒的开发并将 Gazelle 阅读器修改为支持 A1C 检测和定量目标 2：证明 HemeChip A1C 的诊断准确性。根据 NGSP 指南进行预认证试验进行测试：进行临床测试和凭借其易用性和经济性，拟议的 POC A1C 测试已在美国和加纳进行验证。将提供满足发展中国家和其他服务欠缺地区需求的解决方案。