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ce标记和/或fda批准的诊断平台，用于在护理点（POC）和资源有限的环境中监测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、复杂性和体积而不适合这种情况，因此，特别是在发展中国家，往往没有监测患者的治疗效果。然而，估计接受抗病毒治疗（ART）的HIV-1患者的病毒载量被认为是开始和监测ART的最佳标志。现实世界诊断组织（DRW）开发了一个名为SAMBA（基于简单扩增的测定）的POC平台，并建议开发用于血浆和全血样本的SAMBA HIV-1半定量病毒载量检测。这种半定量试验将区分病毒载量高于或低于预先确定的临床相关临界值的患者，以帮助临床医生监测由于耐药性的发展而导致的不依从性、治疗效果或治疗失败。该I期建议是进一步开发和优化血浆和小容量全血样本的化学成分，并通过临床样本的内部测试评估拟议的1,000副本/ml截止值。还将在全血样本中内部评估该测定方法和1,000拷贝/ml的临界值的有效性，随后将在马拉维对接受抗逆转录病毒治疗的患者的样本进行实地试验。保密信息：正在申请专利

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