Point-of-Care HIV-1 Diagnostic with Integrated Nucleic Acid Extraction and Amplification from Whole Blood

Abstract

The HIV/AIDS epidemic continues to be a major global health challenge, and accurate, affordable HIV-1 viral load testing is increasingly needed at the point-of-care (POC). Nucleic acid amplification tests (NAATs) provide high diagnostic accuracy of infectious diseases, yet most systems are restricted to central laboratories due to assay and instrumentation complexity. Here we describe a NAAT with integrated sample preparation and amplification using isotachophoresis and recombinase polymerase amplification. We argue that this approach has the potential to reduce the cost and complexity of point-of-care (POC) NAATs. We demonstrate the detection of HIV-1 nucleic acids in whole blood. Preliminary data demonstrate linearity at low copy number which may provide valuable quantitative data on the HIV viral load of a patient.