Rapid Portable HIV Detection and Monitoring System for Low Resource Settings

描述(由申请人提供)：快速、便携式艾滋病毒检测和监测系统本项目的长期目标是：1.开发一种快速便携式仪器的原型，用于检测和测量患者血液样本中的人类免疫缺陷病毒(HIV)数量，特别是在资源匮乏的情况下。2.开展一项试验性研究，以确定该文书相对于既定参照制度的有效性和比较表现。其目的是为临床医生提供诊断和监测艾滋病毒的工具，这些艾滋病毒存在于资源丰富的环境中，但在资源匮乏的环境中不易获得。特别是，该仪器系统将为临床医生提供有助于识别急性艾滋病毒-1、早期诊断孕妇和婴儿感染、监测治疗后的病毒载量以及监测出现抗逆转录病毒耐药性的检测方法。对服用抗逆转录病毒药物的患者进行病毒载量监测是资源丰富和资源不足之间治疗差异的一个很好的例子。前者是常规治疗，因为如果他们产生艾滋病毒抗药性毒株，对患者和社区构成威胁，数百万接受抗逆转录病毒治疗的人目前没有受到监测，因为其成本和复杂性。这些目标与DAIDS的使命部分是一致的，即“通过支持艾滋病毒感染及其并发症的治疗方法的进步来结束艾滋病毒/艾滋病的流行……”该项目将通过进行紧凑、快速的便携式系统的系统设计，确定所有子系统要求和所需的技术进步，然后着手解决这些问题，从而实现其既定目标。华盛顿大学马萨诸塞州医学院的研究人员将开发一种有效的艾滋病毒聚合酶链式反应分析方法。温度梯度将对关键的PCR扩增装置和DNA样品制备模块的关键方面进行研究，然后将设计和演示集成测试盒和系统所需的性能。Arcxis BioTechnologies预计将为集成盒贡献关键的DNA样本制备技术。最后，该系统的性能(仪器、试剂盒和化验)将首先在使用准备好的血液样本的内部测试中得到验证，然后进行一项重要的先导性研究。 公共卫生相关性：快速、便携式艾滋病毒检测和监测系统一种快速艾滋病毒POC诊断和监测设备将有助于在资源有限的情况下诊断和监测抗逆转录病毒治疗。POC检测可以在实验室设施有限的地区进行艾滋病毒检测，并可以提供做出临床决策所需的即时检测结果。特别是，易于使用的艾滋病毒检测可以改变发展中国家儿科艾滋病毒/艾滋病的管理，避免数百万婴儿死亡，并有助于减轻目前用抗逆转录病毒药物治疗数百万艾滋病毒患者而不监测他们的病毒载量的做法对公共卫生的威胁。

DESCRIPTION (provided by applicant): Rapid, Portable HIV Detection and Monitoring System The long term objectives of this project are: 1. Develop a prototype of a rapid portable instrument for detecting and measuring the amount of Human Immunodeficiency Viruses (HIV's) in samples of patient blood, particularly in low resource settings. 2. Carry out a pilot study to establish the effectiveness and comparative performance of the instrument against an established reference system. The aim is to provide clinicians tools to diagnose and monitor HIV that exist in resource abundant settings but are not readily available in low resource settings. In particular, the instrument system will provide clinicians with detection methods that could be helpful in identifying acute HIV-1, early diagnosis of infection in pregnant women and infants, monitoring viral load following treatment and monitoring for the emergence of antiretroviral resistance. Viral load monitoring of patients on antiretrovirals is a good example of the difference in treatment between resource abundant and low resource settings. Routinely done in the former because of the threat to patients and community should they develop a drug resistant strain of HIV, millions of recipients of antiretroviral therapy currently are not being monitored due to its cost and complexity. These aims are congruent with those parts of the mission of DAIDS "to bring an end to the HIV/AIDS epidemic by supporting the advancement of therapies for HIV infection and its complications...." This project will achieve its stated goals by carrying out a system design of a compact, fast portable system, identifying all the subsystem requirements and required technology advances and then proceeding to tackle them. The researchers at UMass Medical School will develop an effective HIV PCR assay. Thermal Gradient will carry out research on critical aspects of the key PCR amplification device and DNA sample preparation modules, and then will design and demonstrate requisite performance of the integrated test cartridge and system. Arcxis Biotechnologies is expected to contribute key DNA sample preparation technology to the integrated cartridge. Finally, the performance of the system (instrument, cartridge and assay) will be validated, first in internal tests using prepared blood samples and then a significant pilot study. PUBLIC HEALTH RELEVANCE: Rapid, Portable HIV Detection and Monitoring System A rapid HIV POC diagnostic and monitoring device would facilitate diagnosis and monitoring of antiretroviral therapy in resource-limited settings. POC tests can make HIV testing accessible in areas with limited laboratory facilities and can provide immediate test results that are needed to make clinical decisions. In particular, easy-to- use HIV tests could transform the management of pediatric HIV/AIDS in developing countries, averting millions of infant deaths, and help alleviate the threat to public health represented by the current practice of treating millions of HIV patients with antiretrovirals without monitoring their viral loads.