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

 描述（由申请人提供）：本项目的最终目的是开发诊断平台，用于在床旁（POC）和资源有限的环境中使用HIV-1感染患者的全血样本进行病毒载量监测，以提交WHO资格预审和/或CE认证。HIV-1患者抗病毒治疗中病毒载量的估计 抗逆转录病毒治疗（ART）被认为是监测ART疗效、识别和区分不依从性和耐药性的最佳标志物。目前，所有的病毒载量检测都是从血浆样本中进行的，因为使用全血会高估病毒载量，因为有核白色血细胞中整合的HIV DNA会扩增。真实的世界诊断（DRW）开发了桑巴舞HIV-1全血半定量检测（SAMBA-WBSQ），用于第I阶段的POC和资源有限的环境。SAMBA-WBSQ使用白细胞去除来去除有核细胞，并且可以区分病毒载量高于或低于预定临床相关截止值（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。本提案旨在进一步开发和优化SAMBA-WBSQ检测试剂盒，以便向WHO资格预审和/或CE认证提交监管申请。

 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.