SAMBA HIV-1 Semi-quantitative whole blood test for resource limited settings

 描述(由申请者提供)：该项目的最终目标是开发用于病毒载量监测的诊断平台，使用在护理地点(POC)和资源有限的环境中的HIV-1感染者的全血样本，以提交世卫组织资格预审和/或CE标记。接受抗病毒治疗的HIV-1患者的病毒载量估计 治疗(ART)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。目前，所有病毒载量测试都是从血浆样本进行的，因为使用全血会高估病毒载量，因为有核白细胞中整合的艾滋病毒DNA会被放大。现实世界诊断(DRW)已经开发出Samba HIV-1全血半定量检测(Samba HIV-1全血半定量检测)，用于POC和第一阶段资源有限的情况下。Samba-WBSQ使用白细胞去除来去除有核细胞，并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、治疗疗效或治疗失败。这项建议是为了进一步开发和优化Samba-WBSQ检测，以供监管机构提交世卫组织资格预审和/或CE标记。

 DESCRIPTION (provided by applicant): The ultimate aim of this project is to develop diagnostic platform for viral load monitoring using whole blood samples of HIV-1 infected patients in point-of-care (POC) and resource-limited settings to be submitted for WHO prequalification and/or CE-marking. 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. Currently all viral load tests are performed from plasma samples since using whole blood gives an overestimation of the viral load due to amplification of integrated HIV DNA in nucleated white blood cells. Diagnostics for the Real World (DRW) has developed the SAMBA HIV-1 Whole Blood Semi-quantitative Test (SAMBA-WBSQ) for use at POC and in resource-limited setting during Phase I. SAMBA-WBSQ uses leukodepletion to remove the nucleated cells and 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 proposal is to further develop and optimize the SAMBA-WBSQ assay for regulatory submission to WHO prequalification and/or CE-marking.