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

SAMBA HIV-1 半定量全血检测，适用于资源有限的环境

• 批准号: 9142023
• 负责人: HELEN H LEE
• 金额: $ 95.15万
• 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 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9142023
• 关键词: Africa South of the Sahara; Bedside Testings; Biological Assay; Blood Tests; Blood specimen; Cells; DNA; Data; Development; Diagnostic; Evaluation; HIV; HIV-1; Housing; Laboratories; Leukocytes; Monitor; Nucleic Acids; Patients; Performance; Phase; Plasma; Resistance; Resistance development; Resources; Sampling; Small Business Innovation Research Grant; Testing; Treatment Efficacy; Treatment Failure; Viral; Viral Load result; Virus; Whole Blood; anti-viral efficacy; assay development; base; clinically relevant; follow-up; instrument; next generation; non-compliance; point of care; prototype; public health relevance; scale up

 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.