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

描述(申请人提供)：Samba HIV-1资源受限环境下的半定量检测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，用于在护理地点(POC)和资源受限环境下监测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监测ART疗效、识别和区分不依从和耐药的最佳标记物。真实世界诊断(DRW)开发了Samba HIV-1半定量测试(Samba-SQ)，用于POC和第一阶段资源有限的环境中，Samba-SQ可以区分病毒载量高于或低于预先确定的临床相关截止值1,000拷贝/毫升的患者，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。这项第二阶段的建议是进一步开发和优化Samba-SQ，以用于通过手指穿刺法采集的低容量全血样本。然后，全血分析将集成到Samba色谱柱和仪器中，具有全自动进样结果输出POC特性和结果自动解释功能。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进行实地试验，评估原型的性能，并验证检测耐药性的截止日期的临床相关性。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