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

描述（由申请人提供）：桑巴舞HIV-1半定量检测用于资源有限的环境项目摘要本项目的最终目的是开发一个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监测ART疗效、识别和区分不依从和耐药的最佳标志物。真实的世界诊断（DRW）开发了桑巴舞HIV-1半定量检测（桑巴舞- SQ），用于第I阶段的POC和资源有限的环境。SAMBA-SQ可以区分病毒载量高于或低于预先确定的临床相关临界值（1，000拷贝/ml）的患者，以帮助临床医生监测不依从性，治疗疗效或由于耐药性的发展而导致的治疗失败。本II期提案旨在进一步开发和优化SAMBA-SQ，以用于通过手指针刺采集的低容量全血样本。然后将全血测定集成到桑巴舞检测盒和仪器中，具有全自动样品输入结果输出POC特征和自动结果解释。还将设立一个外部质量保证小组，以监测SAMBA-SQ在外地的业绩。然后将在马拉维和乌干达的田间试验中评估原型的性能，并验证检测耐药性的临界值的临床相关性。机密

DESCRIPTION (provided by applicant): SAMBA HIV-1 Semi-quantitative Test for resource limited settings Project Abstract 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 monitoring the efficacy ART, identifying and discriminating non-compliance and resistance. Diagnostics for the Real World (DRW) has developed the SAMBA HIV-1 Semi-quantitative Test (SAMBA- SQ) for use at POC and in resource-limited setting during Phase I. SAMBA-SQ can distinguish between patients with viral loads above or below a predetermined clinically relevant cut-off, of 1,000 copies/ml, to aid clinicians to monitor non-compliance, treatment efficacy or treatment failure due to the development of resistance. This Phase II proposal is to further develop and optimize the SAMBA-SQ for use with low volume whole blood samples collected via finger prick. The whole blood assay will then be integrated into the SAMBA cartridge and instrument with fully automated sample-in-results-out POC characteristics and automated interpretation of results. An External Quality Assurance panel will also be developed to monitor the performance of SAMBA-SQ in the field. The performance of the prototype will then be assessed in field trials in Malawi and Uganda and the clinical relevance of the cut-off for detecting resistance will be validated. Confidential