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

描述（由申请人提供）：本项目的最终目的是开发一种CE认证和/或FDA批准的诊断平台，用于在床旁（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、复杂性和规模而不适合于这种环境，因此患者，特别是发展中国家的患者，通常不被监测治疗效果。然而，接受抗病毒治疗（ART）的HIV-1患者的病毒载量估计被认为是启动和监测ART的最佳标志物。真实的世界诊断（DRW）已经开发了一个称为桑巴舞（基于简单扩增的测定）的POC平台，并建议开发一种用于血浆和全血样本的桑巴舞HIV-1半定量病毒载量检测。这种半定量检测将区分病毒载量高于或低于预定临床相关临界值的患者，以帮助临床医生监测不依从性、治疗有效性或由于耐药性发展而导致的治疗失败。 本I期提案旨在进一步开发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检测评估拟定的1，000拷贝/ml临界值。还将在全血样本中对该测定法和1，000拷贝/ml临界值的有效性进行内部评价，随后将在马拉维对正在接受ART治疗的患者的样本进行实地试验。 公共卫生相关性： 目前正在开发一种用于测量HIV-1病毒水平的简单、高效、廉价的基于核酸的即时检测，以使临床医生能够监测感染患者的治疗效果。研究结果将指导临床医生有效地分配适当的抗逆转录病毒治疗，以防治疗失败是由于缺乏依从性或对治疗的抵抗。这种检测特别适合撒哈拉以南非洲国家的分散检测，因为这些国家资源有限，艾滋病毒流行率高。快速、现场可用的病毒载量监测检测预计将显著减少从样本到结果的周转时间，从而减少失访，从而提高抗病毒治疗的疗效。在某些发达国家，检测通量较低或需要快速周转结果时，该检测也很有用。机密信息：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