SAMBA HIV-1 Semi-quantitative Test for resource limited settings

描述(由申请人提供)：该项目的最终目标是开发一个CE标志和/或FDA批准的诊断平台，用于在护理地点(POC)和资源有限的环境下监测HIV-1感染患者的病毒载量。目前可用的病毒载量测试由于其固有的高成本、复杂性和大小而不适合于这种环境，因此患者，特别是发展中国家的患者，往往没有受到治疗效果的监测。然而，对接受抗病毒治疗(ART)的HIV-1患者的病毒载量的估计被认为是启动和监测ART的最佳标记物。真实世界诊断(DRW)开发了一个名为Samba(基于简单扩增的检测)的POC平台，并提议开发一种Samba HIV-1半定量病毒载量检测，用于血浆和全血样本。这种半定量检测将区分病毒载量高于或低于预先确定的临床相关分界点的患者，以帮助临床医生监测由于耐药性的发展而导致的不依从、治疗效果或治疗失败。这项第一阶段的建议是进一步发展和优化血浆和低容量全血样本的化学，并通过临床样本的内部测试来评估拟议的1,000份/毫升的临界值。该检测方法和1,000拷贝/毫升截止值的有效性也将在全血样本中进行内部评估，随后将在马拉维对正在接受抗逆转录病毒治疗的患者样本进行现场试验。机密信息：专利申请正在进行中 公共卫生相关性：正在开发一种简单、高性能、廉价的基于核酸的护理点检测方法，用于测量艾滋病毒-1病毒水平，以使临床医生能够监测感染患者的治疗效果。这一结果将指导临床医生在治疗失败的情况下有效地分配适当的抗逆转录病毒治疗，因为缺乏依从性或对治疗的抵抗力。这种检测特别适用于撒哈拉以南非洲国家的分散检测，这些国家的资源有限，艾滋病毒流行率很高。快速、现场可用的病毒载量监测分析预计将显著减少从样本到结果的周转时间，从而减少后续行动的损失，从而提高抗病毒治疗的有效性。该测试在某些发达国家的环境中也很有用，在这些环境中，测试吞吐量很低，或者当需要快速扭转结果时。机密信息：专利申请正在进行中

DESCRIPTION (provided by applicant): The ultimate aim of this project is to develop a CE-marked and/or FDA-approved diagnostic platform for viral load monitoring of HIV-1 infected patients in point-of-care (POC) and resource- limited settings. Currently available viral load tests are not suitable for such settings due to their inherent high cost, complexity and size, thus patients, especially in the developing world, are often not monitored for treatment efficacy. However, estimation of viral load in HIV-1 patients receiving anti-viral treatment (ART) is considered the best marker for the initiation and monitoring of ART. Diagnostics for the Real World (DRW) has developed a POC platform called SAMBA (Simple AMplification Based Assay) and proposed to develop a SAMBA HIV-1 semi-quantitative viral load test for plasma and whole blood samples. This semi-quantitative test will distinguish patients with viral loads above or below a predetermined clinically relevant cut-off to aid clinicians to monitor non-compliance, treatment efficacy or treatment failure due to the development of resistance. This Phase I proposal is to further develop and optimize the chemistry for plasma and low volume whole blood samples, and assess the proposed 1,000 copies/ml cut-off with in-house testing of clinical samples. The assay and the validity of the cut-off at 1,000 copies/ml will also be evaluated in-house in whole blood samples, to be followed by a field trial in Malawi in samples from patients under going ART. Confidential information: patent application in process PUBLIC HEALTH RELEVANCE: A simple, high-performance, inexpensive nucleic acid-based point-of-care test for the measurement of HIV-1 viral level is being developed to enable clinicians to monitor treatment efficacy in infected patients. The results will guide clinicians to effectively dispense the appropriate anti- retroviral therapy in case treatment failure results from lack of compliance or resistance to therapy. This test is particularly appropriate for decentralized testing in sub-Saharan African countries where resources are limited and HIV prevalence is high. Rapid, on-site availability of a viral load monitoring assay is expected to reduce significantly the turn-around time from sample to result and hence loss-to- follow-up, therefore increasing the efficacy of anti-viral therapy. The test can also be useful in certain developed country settings where test throughput is low or when rapid turnaround of the results is needed. Confidential information: patent application in process