Abstract

Although the accessibility of HIV treatment in developing nations has increased dramatically over the past decade, viral load testing to monitor the response of patients receiving therapy is often unavailable. Existing viral load technologies are often too expensive or resource-intensive for poor settings, and there is no appropriate HIV viral load test currently available at the point-of-care in low resource settings. Here, we present a lateral flow assay that employs gold nanoparticle probes and gold enhancement solution to detect amplified HIV RNA quantitatively. Preliminary results show that, when coupled with nucleic acid sequence based amplification (NASBA), this assay can detect concentrations of HIV RNA that match the clinically relevant range of viral loads found in HIV patients. The lateral flow test is inexpensive, simple and rapid to perform, and requires few resources. Our results suggest that the lateral flow assay may be integrated with amplification and sample preparation technologies to serve as an HIV viral load test for low-resource settings.

Highlights

  • Over two-thirds of the 33.3 million people estimated to be infected with HIV worldwide live in the developing world [1]

  • Our results indicate that this lateral flow assay may be used in conjunction with amplification to detect HIV RNA concentrations at clinically meaningful levels

  • When RNA is dispensed onto the conjugate pad of the strip, the RNA binds to complementary oligonucleotides conjugated to gold nanoparticle probes (GNPs)

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Summary

Introduction

Over two-thirds of the 33.3 million people estimated to be infected with HIV worldwide live in the developing world [1]. Successful management of HIV requires that patients receiving ART be monitored routinely to assess treatment efficacy and detect treatment failure due to drug resistance. Current laboratory based methods to monitor ART are unaffordable, unavailable, or inappropriate for low-resource settings [3]. Rapid antibody tests are widely available in developing nations, but they cannot be used to monitor HIV progression or treatment efficacy. The standard of care to monitor ART is quantitative viral load testing based on plasma HIV RNA concentration [4]. CD4 count has been used to monitor ART, recent studies suggest that it may not detect early treatment failure adequately [5]. The gold standard method for viral load testing, RT-qPCR, is unsuitable for settings where trained technicians, expensive reagents, electrically powered equipment, and dedicated laboratory space are often unavailable. A viral load test that is appropriate for such settings is needed

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