Rapid Portable HIV Detection and Monitoring System for Low Resource Settings

项目描述（由申请人提供）：快速、便携的HIV检测和监测系统。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人类免疫缺陷病毒（HIV）的数量，特别是在资源匮乏的环境中。2. 进行一项试点研究，以确定该仪器与既定参考系统的有效性和比较性能。其目的是为临床医生提供诊断和监测艾滋病毒的工具，这些工具在资源丰富的环境中存在，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检测方法，有助于确定急性HIV-1、早期诊断孕妇和婴儿感染、监测治疗后的病毒载量和监测抗逆转录病毒耐药性的出现。对接受抗逆转录病毒药物治疗的患者进行病毒载量监测是一个很好的例子，说明了资源丰富和资源匮乏环境之间的治疗差异。由于患者和社区一旦发展出耐药的艾滋病毒毒株，就会受到威胁，因此在前一种情况下通常是这样做的。由于抗逆转录病毒治疗的费用和复杂性，目前数百万接受抗逆转录病毒治疗的人没有得到监测。这些目标与艾滋病规划署“通过支持改进艾滋病毒感染及其并发症的治疗方法来结束艾滋病毒/艾滋病的流行....”的部分使命是一致的。该项目将实现其既定目标，通过执行一个紧凑、快速的便携式系统的系统设计，确定所有子系统需求和所需的技术进步，然后继续解决它们。马萨诸塞大学医学院的研究人员将开发一种有效的HIV PCR检测方法。热梯度将对关键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的必要性能。Arcxis生物技术公司预计将为集成盒提供关键的DNA样品制备技术。最后，系统（仪器、药筒和化验）的性能将得到验证，首先在使用制备的血液样本进行内部测试，然后进行重要的试点研究。

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.