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 患者血液样本中人类免疫缺陷病毒（HIV）的量， 特别是在低资源环境中。 2.开展试点研究，以确定 将仪器与已建立的参考系统进行比较。其目的是为临床医生提供诊断和监测艾滋病毒的工具，这些工具存在于资源丰富的环境中，但在资源匮乏的环境中不容易获得。 特别是，该仪器系统将为临床医生提供检测方法，有助于识别急性HIV-1，早期诊断孕妇和婴儿感染，监测治疗后的病毒载量，并监测抗逆转录病毒耐药性的出现。 对使用抗逆转录病毒药物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不足环境之间的治疗差异。 在前一种情况下，由于对患者和社区的威胁，如果他们发展出艾滋病毒的耐药性菌株，数百万接受抗逆转录病毒治疗的人目前由于其成本和复杂性而没有受到监测。 这些目标与艾滋病司的使命中的部分内容是一致的，即“通过支持艾滋病毒感染及其并发症治疗方法的进步，结束艾滋病毒/艾滋病的流行.”。他说：“这项计划将透过设计一个紧凑、快速的便携式系统，确定所有子系统的要求和所需的技术进步，然后着手解决这些问题，以达到既定的目标。 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。 Thermal Gradient将对关键PCR扩增设备和DNA样本制备模块的关键方面进行研究，然后设计并证明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，将对系统（仪器、检测盒和检测试剂盒）的性能进行验证，首先使用制备的血液样本进行内部测试，然后进行重要的初步研究。 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的艾滋病毒POC诊断和监测装置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检测可以使实验室设施有限的地区获得艾滋病毒检测，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，并有助于减轻目前在不监测病毒载量的情况下用抗逆转录病毒药物治疗数百万艾滋病毒患者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.