IGF::OT::IGF SIMPLE, INEXPENSIVE UNIT FOR REMOVING CELLS FROM SMALL AMOUNTS OF BLOOD IN RESOURCE-LIMITED SETTINGS

IGF::OT::IGF 简单、廉价的装置，用于在资源有限的环境中从少量血液中去除细胞

• 批准号: 9149675
• 负责人: RITWIK GHOSH
• 金额: $ 22.36万
• 依托单位: LYNNTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-18 至 2016-08-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9149675
• 关键词: Biological Assay; Blood; Blood specimen; Cells; Country; DNA; Drug resistance; Electricity; Ensure; Evaluation; Excision; Failure; Fingers; Goals; HIV; Human immunodeficiency virus test; Measures; Methods; Morbidity - disease rate; One-Step dentin bonding system; Patient Monitoring; Patients; Peripheral Blood Mononuclear Cell; Plasma; Process; Production; Quality Control; RNA; Recommendation; Regimen; Resources; Sensitivity and Specificity; Signal Transduction; Site; Technology; Test Result; Testing; Treatment Protocols; Validation; Viral Load result; Viral load measurement; Whole Blood; antiretroviral therapy; cost; mortality; point of care; programs; scale up

The rollout of antiretroviral therapy (ART) in resource-limited countries has resulted in substantial reductions in mortality and morbidity due to HIV. While ART regimens are very potent and reduce viral load (measured as HIV RNA copies/ml of plasma) to undetectable levels, virological failure still occurs in some patients. In most resource-limited settings, viral load measurement is not used to routinely monitor patients for virological failure due to cost and complexity of the test. Therefore, many patients are not switched to a second line therapy regimen in a timely manner, which can contribute to drug resistance, and many others are being switched unnecessarily to more costly treatment regimens. For this reason, current WHO recommendations include the use of viral load testing where feasible to monitor patients on ART for virological failure. Over the next several years, the use of viral load testing is expected to increase dramatically, with much of the increase due to new, simple viral load tests that can be performed at the point of care (POC). Whole blood contains both HIV RNA in plasma, as well as HIV RNA and DNA in peripheral blood mononuclear cells (PBMCs). This can cause inaccuracies in the test results, especially at the lower end of the linear range of the test, where the HIV RNA and DNA in cells can constitute a high proportion of the total HIV signal in the blood sample. A simple, inexpensive method for removing cells from very small amounts of blood is needed for use with POC HIV viral load assays. Removal of the cells must be performed very quickly in one step at the POC, without the need for electricity, and the resulting plasma must provide accurate and reproducible results in POC viral load assays. The goal of this solicitation is to develop an inexpensive, easy to use process that will remove cells from finger stick blood samples (approximately 500 ul) prior to use in POC viral load assays.

在资源有限的国家推出抗逆转录病毒疗法，大大降低了艾滋病毒造成的死亡率和发病率。虽然ART方案非常有效，并将病毒载量（以HIV RNA拷贝/ml血浆测量）降低到无法检测的水平，但在一些患者中仍然发生病毒学失败。在大多数资源有限的环境中，由于测试的成本和复杂性，病毒载量测量不用于常规监测患者的病毒学失败。因此，许多患者没有及时转换到二线治疗方案，这可能导致耐药性，并且许多其他患者不必要地转换到更昂贵的治疗方案。因此，世卫组织目前的建议包括在可行的情况下使用病毒载量检测，以监测接受抗逆转录病毒治疗的患者的病毒学失败。在接下来的几年里，预计病毒载量检测的使用将大幅增加，其中大部分增加是由于可以在护理点（POC）进行的新的简单病毒载量检测。全血含有血浆中的HIV RNA以及外周血单核细胞（PBMC）中的HIV RNA和DNA。这可能导致测试结果不准确，特别是在测试线性范围的低端，其中细胞中的HIV RNA和DNA可能构成血液样本中总HIV信号的高比例。POC HIV病毒载量检测需要一种简单、廉价的方法从极少量的血液中去除细胞。细胞的去除必须在POC的一个步骤中非常快速地进行，而不需要电力，并且所得的血浆必须在POC病毒载量测定中提供准确和可再现的结果。 该征集的目标是开发一种廉价、易于使用的方法，该方法将在用于POC病毒载量测定之前从手指针刺血液样品（约500 μ l）中去除细胞。