alexa A Rapid, Self-confirming Assay for HIV: Simultaneous Detection of Anti- HIV Antibodies and Viral RNA
ISSN 2155-6113

Journal of AIDS & Clinical Research
Open Access

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Research Article

A Rapid, Self-confirming Assay for HIV: Simultaneous Detection of Anti- HIV Antibodies and Viral RNA

Zongyuan Chen1, Hui Zhu1, Daniel Malamud2,3, Cheryl Barber2, Yhombi Yvon Serge Ongagna2, RubinaYasmin1, Sayli Modak2, Malvin N. Janal2, William R. Abrams2 and Richard A. Montagna1*

1Rheonix, Inc., Ithaca, New York, USA

2New York University College of Dentistry, Department of Basic Sciences, New York, USA

3New York University School of Medicine, Department of Medicine, New York, USA

*Corresponding Author:
Richard A. Montagna
Senior Vice President
Scientific and Clinical Affairs
Rheonix, Inc., Ithaca, New York , USA
Tel: 716-773-4232
Fax: 607-257-0979
Email: [email protected]

Received date: December 22, 2015 Accepted date: January 29, 2016 Published date: January 31, 2016

Citation: Chen Z, Zhu H, Malamud D, Barber C, Ongagna YYS, et al. (2016) A Rapid, Self-confirming Assay for HIV: Simultaneous Detection of Anti-HIV Antibodies and Viral RNA. J AIDS Clin Res 7:540. doi:10.4172/2155-6113.1000540

Copyright: © 2016 Chen Z, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



Objective: We developed a microfluidic system to simultaneously detect host anti-HIV antibodies and viral RNA in the same specimen in order to satisfy two important diagnostic criteria, especially within resource-limited settings. First, the system can detect acute HIV infection and allow immediate confirmation of a seropositive screening result by detection of HIV RNA. It also addresses the well-known "seroconversion window" during early HIV infection when antibodies are not yet detectable and viral loads are at their highest.

Methods: We first developed and optimized two separate manual assays for the detection of host anti-HIV antibodies and viral RNA and then converted them to the microfluidic system. We optimized a commercially available serologic assay to run within the microfluidic device while we incorporated the isothermal LAMP assay to detect the presence of viral RNA. The microfluidic device and instrumentation were developed to simultaneously perform both assays without any user intervention.

Results: The finalized system consists of a disposable injection molded and film-laminated microfluidic CARD disposable device and a portable, software controlled instrument, which together can automatically perform all steps of both assays without any user intervention after the initial loading of samples and reagents. The microfluidic CARD cartridge has multiple microchannels, valves, pumps and reservoirs, which perform the immunoassay, isolates viral RNA for detection by magnetic bead based purification, and Reverse Transcriptase loop-mediated isothermal amplification (RT-LAMP). The microfluidic system was able to detect host anti-HIV antibodies and viral RNA in either a blood or saliva sample.

Conclusion: The ability to detect antibodies and simultaneously confirm a seropositive HIV-RNA result provides healthcare workers with a complete and accurate appraisal of a patient's infection status in the earliest stages of the disease and represents an important tool for the "Test and Treat" and "Treatment as Prevention" approaches for controlling the HIV epidemic.


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