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

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