Cell analysis & immunoassay device for distributed HIV diagnosis and monitoring

描述(申请人提供)：这项研究的目标是开发一种新的方法，通过引入一种便携式、低成本和易于使用的多功能细胞分析和免疫分析平台，将艾滋病毒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、小型保健诊所和实验室，以及社区卫生中心实验室)。它将允许患者接受常规血液测试(全血计数或CBC)，这是初级保健中的一项基本测试，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测试)和CD4计数的测试。在未来，拟议的系统将允许引入基于珠子的艾滋病毒核酸测试。该平台将通过早期诊断艾滋病毒、增强患者对开始使用抗逆转录病毒药物的准备、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保健中的留存，来改善艾滋病毒治疗结果。此外，由于免疫抑制的艾滋病毒患者更容易受到机会性感染，而且往往还容易患上贫血和其他血液学问题，通过在初级保健层面及早诊断此类疾病，这一平台将帮助医生更好地管理这些患者的整体健康。这一新平台将以协同的方式将基于荧光的流式细胞仪技术和全光自动血液学分析技术结合起来，利用正在申请专利的分析协议和独特的硬件/软件设计和组件来实现。通过更快地提供诊断结果，拟议的系统有可能提高患者对艾滋病毒感染状况的认识水平，从而改善对受感染个人的教育和行为改变。在分布式护理环境中快速返回结果还有可能减少通常与测试结果的长周转时间相关的跟随-p的损失，特别是在资源有限的环境中。同样，在护理地点或更接近护理地点进行CD4监测，有可能提高护理质量，显著降低发病率，使卫生保健提供者能够更快、更适当地调整治疗，以确保改善治疗结果。总之，这些措施将通过提高认识减少感染的传播，并提高治疗质量，从而大大减少全球艾滋病毒流行病的影响，从而减轻艾滋病毒发病率和因艾滋病毒疾病失控而导致的死亡率所造成的社会影响。

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.