Point-of-care HIV viral load system using RPA and MXR

ABSTRACT The most accurate way to monitor the efficacy of antiretroviral therapy is through nucleic acid amplification tests (NAATs) that directly measure HIV RNA (viral load). In the developing and developed world these tests are primarily conducted in centralized laboratories in urban centers. However, a significant number of persons living with HIV reside in rural locations, and due tolack of transportation, financial constraints, or a combination of these factors, would be better served by a test closer to the point-of-care (POC). Despite advancements in portable nucleic acid amplification technology there remains significant opportunity to improve affordability, time- to-result, and ease-of-use of POC HIV viral load (VL) testing. To this end we will complete development of our rapid, sample-to-answer HIV VL test that achieves better metrics in these areas than today’s commercial platforms. In this Phase II project, we will continue our collaboration with the Diagnostics Program at PATH (Seattle, WA) to finalize and test the completed device. In Aim 1 Redbud Labs will finalize and integrate the test cartridge and device into a compact, robust instrument. In Aim 2 Redbud Labs will verify quantitation and genomic coverage of the automated assay. In Aim 3 PATH will perform analytic validation of the system using clinical samples, comparing those results against a gold standard. At this project’s completion we will have a platform ready for multi-site clinical validation.