Cell analysis & immunoassay device for distributed HIV diagnosis and monitoring

细胞分析

• 批准号: 8776168
• 负责人: Chiranjit Deka
• 金额: $ 22.5万
• 依托单位: INDEXUS BIOMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-07 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8776168
• 关键词: Anemia; Anti-Retroviral Agents; Antigens; Awareness; Basophils; Behavior Therapy; Biological Assay; Blood Platelets; Blood Tests; Blood specimen; Bread; CD4 Lymphocyte Count; CD8B1 gene; Caring; Cells; Clinic; Community Health Centers; Complete Blood Count; Computer software; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Differential white blood cell count procedure; Disease; Education; Electronics; Epidemic; Erythrocytes; Flow Cytometry; Fluorescence; Future; Goals; HIV; HIV Antibodies; HIV Antigens; HIV Infections; HIV Seropositivity; HIV diagnosis; Health; Healthcare; Hematology; Human immunodeficiency virus test; Immune; Immunoassay; Individual; Infection; Legal patent; Leukocytes; Lymphocyte; Lytic; Medical; Monitor; Morbidity - disease rate; Nucleic Acid Amplification Tests; Opportunistic Infections; Optics; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Platelet Count measurement; Primary Health Care; Procedures; Protocols documentation; Provider; Quality of Care; Readiness; Reagent; Red Blood Cell Count; Research; Resources; Reticulocytes; Sampling; Software Design; System; Systems Integration; Technology; Test Result; Testing; Time; Treatment outcome; Validation; Whole Blood; Work; base; compliance behavior; cost; design; eosinophil; improved; instrument; light scattering; meetings; monocyte; mortality; neutrophil; novel; novel strategies; point of care; prospective; prototype; public health relevance; sensor; software systems

DESCRIPTION (provided by applicant): The goal of this research is to develop a new approach to bring diagnosis and monitoring tests for HIV to the primary care level (primary care provider office, small healthcare clinics and labs, and community health center labs) by introducing a multi-functional cell analysis and immunoassay platform that is portable, low cost and easy to use. It will allow patients to be tested for routine blood tests (complete blood count or CBC), an essential test in primary care, and also permit tests for detection of HIV infection (HIV-antibody and antigen tests) and CD4 counts on the same system. In the future the proposed system will allow the introduction of bead-based nucleic acid testing for HIV. This platform will improve HIV treatment outcomes by diagnosing HIV early, enhancing patient readiness for initiation of antiretroviral medications, improving and sustaining patient adherence to antiretroviral medications, and improving patient retention in medical care. Additionally, as immune suppressed HIV patients are more susceptible to opportunistic infections and are often prone to also suffer from anemia and other hematological issues, by enabling the diagnosis of such conditions early at the primary care level, this platform will help the physicians better manage the overall health of these patients. This novel platform will be accomplished by combining technologies for fluorescence based flow cytometry and all-optical automated hematology analysis in a synergistic way, leveraging patent pending assay protocols and unique hardware/software designs and components. By rendering diagnostic results more quickly, the proposed system has the potential to increase the level of awareness of HIV infection status in patients, permitting improved education and behavior modification for infected individuals. Rapid return of results in distributed care settings also has the potential to reduce the loss to follow-p that is often associated with long turnaround times for test results, particularly in resource-limited settings. Similarly, performing CD4 monitoring at or closer to the point of care has the potential to improve the quality of care and reduce morbidity significantly, enabling heath care providers to adjust treatment more rapidly and appropriately, in order to assure improved treatment outcomes. Together, these will contribute significantly to reduce the impact of the global HIV epidemic by reducing the spread of infection through awareness, and by improving the quality of treatment, thus mitigating the societal impact associated with HIV morbidity and mortality due to uncontrolled HIV disease.

描述（由申请人提供）：本研究的目标是开发一种新方法，通过引入便携式、低成本和易于使用的多功能细胞分析和免疫测定平台，将HIV的诊断和监测测试带到初级保健水平（初级保健提供者办公室、小型医疗诊所和实验室以及社区卫生中心实验室）。它将允许患者进行常规血液检查（全血细胞计数或CBC），这是初级保健中的一项基本检查，还允许在同一系统上进行艾滋病毒感染检测（艾滋病毒抗体和抗原检测）和CD 4计数检测。在未来，拟议的系统将允许引入基于珠的艾滋病毒核酸检测。该平台将通过早期诊断艾滋病毒、提高患者开始抗逆转录病毒药物治疗的准备程度、改善和维持患者对抗逆转录病毒药物的依从性以及改善患者在医疗护理中的保留率来改善艾滋病毒治疗的结果。此外，由于免疫抑制的HIV患者更容易受到机会性感染，并且往往也容易患有贫血和其他血液学问题，通过在初级保健水平早期诊断这些疾病，该平台将帮助医生更好地管理这些患者的整体健康。这个新平台将通过以协同方式结合基于荧光的流式细胞术和全光学自动血液学分析技术，利用正在申请专利的分析方案和独特的硬件/软件设计和组件来实现。通过更快地呈现诊断结果，所提出的系统有可能提高患者对HIV感染状况的认识水平，从而改善对感染者的教育和行为矫正。在分布式医疗环境中快速返回结果也有可能减少后续损失，这通常与测试结果的长周转时间相关，特别是在资源有限的环境中。同样，在或更接近护理点进行CD 4监测有可能提高护理质量并显着降低发病率，使医疗保健提供者能够更迅速，更适当地调整治疗，以确保改善治疗结果。所有这些将大大有助于减少全球艾滋病毒流行病的影响，通过提高认识减少感染的蔓延，并提高治疗质量，从而减轻与艾滋病毒疾病失控造成的艾滋病毒发病率和死亡率相关的社会影响。