DIAGNOSTICS FOR THE REAL WORLD LIMITED — Department of Health and Human Services SBIR Phase II: R

Description

DESCRIPTION provided by applicant SAMBA HIV 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 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 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 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 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 ConfidentialPUBLIC HEALTH RELEVANCE SAMBA HIV Semi quantitative Test for resource limited settings Project Narrative The SAMBA Semi quantitative Test is a simple high performance and robust nucleic acid based point of care test for HIV load monitoring The test was developed in Phase I to enable clinicians to monitor viral load in HIV infected patients on the basis of a copies cut off Availability of a viral load monitoring assay at point of care is expected to enable a test and treat strategy and hence massively reduce loss to follow up increasing the efficacy of anti viral therapy monitoring The test has been evaluated in house and in sub Saharan Africa with patient samples and results were highly concordant with commercially available tests In Phase II we will further improve the SAMBA assay to include processing of whole blood and automated reading of results to ensure it is more suitable for point of care settings These new features will be tested in a second field trial and incorporated into the final product if found to be beneficial