Proof-of-Concept for Card-Based CD4 Cell Counting

基于卡的 CD4 细胞计数的概念验证

• 批准号: 7120776
• 负责人: Harold Edward Ayliffe
• 金额: $ 30.03万
• 依托单位: E.I. SPECTRA, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7120776
• 关键词: HIV infections; bioengineering /biomedical engineering; biomedical equipment development; cell sorting; clinical biomedical equipment; clinical research; consumable /disposable biomedical equipment; cost effectiveness; electrical impedance; evaluation /testing; flow cytometry; helper T lymphocyte; human tissue; immunomagnetic separation; leukocyte count; microarray technology; microfluidics; microprocessor /microchip; monocyte; portable biomedical equipment

DESCRIPTION (provided by applicant): The long-term objective of this proposed research is to develop a simple, inexpensive point-of-care device that will purify CD4+ T cells from whole blood and perform absolute CD4+ T cell counts. This will be accomplished by adapting, combining, and testing a prototype chip-based flow-through particle counter with a separate passive microfluidic cell separation and purification technique. Toward this objective, Phase I will investigate four aims focused on establishing a proof-of-concept system using these technologies to count CD4+ T cells. Aim One will determine the feasibility of using a CD4 passive microfluidic "prep card" capable of purifying CD4+ T cells from whole blood. Aim Two will determine the feasibility of using microfabricated chips to count the isolated ceils in a disposable platform. Aim Three will determine the feasibility of using a simple electronic interface to reliably count the CD4+T cells. Aim Four will test and validate the individual CD4 counting components using commercially available normal blood specimens. Upon completion of these four aims, Phase II will focus on integrating the microfluidic separation "prep card" with the microfabricated counter chips to produce a single component, one-time use CD4 counter cartridge. This new system will then undergo further validation and optimization in preparation for field trials against existing industry gold standards for CD4 analysis. The resulting device, when fully validated and evaluated in the proposed scenarios of use, will be simple, robust, and unique in that it provides a fully quantitative CD4+ T cell analysis with an instrument costing less than $300. This is almost two orders of magnitude below the cost of established flow cytometry devices. Reagent and disposable costs will also be lower than that of any currently available device. The tool will find immediate application in all levels of the public health care system, particularly in resource-poor areas and developing countries, for monitoring persons with human immunodeficiency virus (HIV), formulating differential diagnoses, and making therapeutic decisions regarding anti-retroviral drug treatment regimes, including the highly active anti-retroviral therapy (HAART) approach.

描述(由申请人提供)：这项拟议研究的长期目标是开发一种简单、廉价的护理设备，该设备将从全血中纯化CD4+T细胞，并进行绝对的CD4+T细胞计数。这将通过调整、组合和测试基于芯片的流动颗粒计数器原型和独立的无源微流控细胞分离和纯化技术来实现。为了这个目标，第一阶段将调查四个目标，重点是建立一个使用这些技术来计数CD4+T细胞的概念验证系统。目的确定使用一种可从全血中分离纯化CD4+T细胞的被动微流控“预备卡”的可行性。目的二将确定使用微制造芯片对一次性平台中的分离细胞进行计数的可行性。目的三将确定使用简单的电子接口可靠地计数CD4+T细胞的可行性。目标四将使用商业上可获得的正常血液样本来测试和验证单个CD4计数组件。在完成这四个目标后，第二阶段将专注于将微流控分离“预备卡”与微型制造的计数器芯片集成在一起，生产出单一组件、一次性使用的CD4计数器盒。然后，这一新系统将接受进一步的验证和优化，以准备对照现有的用于CD4分析的行业黄金标准进行现场试验。当在建议的使用方案中进行充分验证和评估时，所产生的设备将是简单、坚固和独特的，因为它用一台成本不到300美元的仪器提供完全定量的CD4+T细胞分析。这几乎比现有的流式细胞仪设备的成本低两个数量级。试剂和一次性成本也将低于目前任何可用的设备。该工具将立即在各级公共卫生保健系统中得到应用，特别是在资源匮乏地区和发展中国家，用于监测人类免疫缺陷病毒(艾滋病毒)感染者，制定鉴别诊断，并就抗逆转录病毒药物治疗制度作出治疗决定，包括高效抗逆转录病毒疗法(HAART)。