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

适用于资源有限环境的 SAMBA HIV-1 半定量检测

• 批准号: 8659952
• 负责人: HELEN H LEE
• 金额: $ 74.75万
• 依托单位: DIAGNOSTICS FOR THE REAL WORLD, LTD
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-03 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8659952
• 关键词: Africa South of the Sahara; Bedside Testings; Biological Assay; Blinded; Blood specimen; Cells; Centrifugation; Characteristics; Clinical; Cold Chains; Counseling; Country; DNA; Developing Countries; Development; Diagnostic; Ensure; Evaluation; FDA approved; Filtration; Fingers; Freezing; HIV; HIV-1; Heating; Hospitals; Housing; Human Resources; Infection; Laboratories; London; Low income; Malawi; Manuscripts; Molecular; Monitor; Nature; Nucleic Acids; Patients; Performance; Phase; Process; RNA; Reader; Reading; Reproducibility; Research Infrastructure; Resistance; Resistance development; Resources; Sampling; Shipping; Ships; Small Business Innovation Research Grant; System; Testing; Training; Treatment Efficacy; Treatment Failure; Uganda; Validation; Viral; Viral Load result; Visual; Whole Blood; abstracting; anti-viral efficacy; assay development; base; clinically relevant; clinically significant; cost; follow-up; improved; instrument; non-compliance; point of care; pol genes; prototype; public health relevance; quality assurance; resistance mutation

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

描述（由申请人提供）：资源有限设置项目的Samba HIV-1半定量测试摘要该项目的最终目的是开发CE标记和/或FDA批准的诊断平台，用于对HIV-1感染的患者（POC）（POC）（POC）（POC）和资源限时设置的HIV-1感染患者进行病毒负荷监测。目前，由于其固有的高成本，复杂性和大小，目前可用的病毒负荷测试不适合这种设置，因此患者，尤其是在发展中国家的患者，通常不接受治疗功效的监测。但是，接受抗病毒治疗（ART）的HIV-1患者中病毒负荷的估计被认为是监测疗效艺术，识别和区分违规和耐药性的最佳标志。现实世界（DRW）的诊断已经开发了Samba HIV-1半定量测试（SAMBA-SQ）在POC和资源限制的环境中使用。Samba-SQ可以区分高于或低于预测的临床相关临床相关的临床削减率或低于1000份副本的病毒载荷的患者，以临床的临床医生的临床治疗效率，以监控治疗效率，以效率地进行了治疗效率，以不利的治疗方法进行了效率或不可用的治疗方法。该II期建议是进一步开发和优化SAMBA-SQ，可与通过指尖收集的低体积全血样品一起使用。然后，整个血液测定法将集成到具有全自动的POC特征和结果解释的桑巴弹药筒和仪器中。还将开发一个外部质量保证面板，以监视该领域的Samba-SQ的性能。然后，将在马拉维和乌干达的现场试验中评估该原型的性能，并将验证截止性临界值的临床相关性。机密的