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

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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