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）：针对资源有限环境的 SAMBA HIV-1 半定量检测 项目摘要 该项目的最终目标是开发一个具有 CE 标志和/或 FDA 批准的诊断平台，用于在护理点 (POC) 和资源有限环境中监测 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这种情况，因此患者，特别是发展中国家的患者，通常不会监测治疗效果。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、识别和区分不依从性和耐药性的最佳标志。 Diagnostics for the Real World (DRW) 开发了 SAMBA HIV-1 半定量检测 (SAMBA-SQ)，用于 POC 和 I 期资源有限的环境中。SAMBA-SQ 可以区分病毒载量高于或低于预定临床相关临界值（1,000 拷贝/毫升）的患者，以帮助临床医生监测不依从性、治疗效果或由于耐药性产生而导致的治疗失败。该第二阶段提案旨在进一步开发和优化 SAMBA-SQ，以用于通过手指采血采集的低容量全血样本。然后，全血检测将集成到 SAMBA 试剂盒和仪器中，具有全自动样本输入结果 POC 特征和自动结果解释。还将开发一个外部质量保证小组来监控 SAMBA-SQ 在现场的表现。然后将在马拉维和乌干达的现场试验中评估原型的性能，并验证耐药性检测截止值的临床相关性。机密的