Developing an Automated HIV Self-Test for Use in Developing Countries

There are more than 38 million people living with HIV worldwide, and at least 20 percent of them aren’t aware of their HIV status. This issue is compounded by the fact that many developing countries don’t have the resources to distribute self-testing assays throughout the population, nor do they have the infrastructure or manpower for HIV testing in a laboratory setting.

To combat this issue, Florida Atlantic University’s (FAU’s) College of Engineering and Computer Science, along with the FAU’s Schmidt College of Medicine, have been given a three-year, $1.3 million grant from the National Institutes of Health to develop an automated HIV self-testing assay that overcomes the hurdles past HIV self-tests have faced. Holden Galusha, associate editor of G2’s partner brand, Lab Manager, speaks with Waseem Asghar, PhD, principal investigator and associate professor at the FAU Department of Electrical Engineering and Computer Science about the initiative.

Q: What inspired you to work on this project?

A: More than 38 million people are living with AIDS worldwide. Approximately 940,000 people died of AIDS in 2017. The epidemic continues to grow with nearly 1.8 million new cases in 2017, including over 39,000 new cases in the US. In addition, worldwide, about at least 20 percent of HIV-positive individuals are unaware of their HIV status. Antiretroviral therapy (ART) is recommended for all individuals with HIV. Although ART is effective in limiting viral replication and spread, it doesn’t eradicate the virus in infected patients. Furthermore, nearly 40 percent of people infected with HIV are not on suppressive treatments despite first-line ART being affordable or even freely available. This is also due to the lack of easy-to-use and cost-effective HIV diagnostics for self-testing. A low-cost and easy-to-access platform for HIV testing is required for an improved diagnosis during the acute phase of the infection (first few weeks post-infection), identification of treatment failure, and disease management. People who do not know they have HIV cannot take advantage of HIV care and treatment and may unknowingly infect others.

When I observed that HIV is a big problem and there hasn’t much improvement in HIV testing for a long time, I took it as a challenge and started thinking about developing an innovative HIV testing method that can help millions of people around the world.

Q: As of now, no other self-tests can detect HIV-1 in the early stages of acute infection or viral rebound, but yours can. What is different about your self-test that enables it to do so?

A: It’s challenging to develop molecular tests that can detect HIV at point-of-care (POC) and home settings. The current standard, RT-PCR-based testing, is expensive and requires a trained technician to run the assay in a high-tech lab. The big challenge is the sample preparation steps that include plasma isolation from blood, virus lysis, RNA isolation and cleaning, followed by amplification. Current testing methods do not offer these capabilities to run the test in self-testing or POC settings. The device that we are developing will be the first of its kind: a fully automated, sample-in-answer-out system for automated testing of HIV-1. The device requires minimal user manipulation; after the blood sample is loaded into the well, all remaining virus isolation and detection steps will be fully automated using the handheld magnetic actuation platform. The test result can be visualized within 40 minutes—this is an extremely short timeframe when compared to conventional assays, which require several hours and access to a clinical lab infrastructure.

Q: Why is it so vital that HIV be detected in the acute stage of infection?

A: During the acute phase, the infected person can easily spread the virus to other people without even knowing that the person is infected. Therefore, it’s critical to have testing methods that can detect HIV in a self-testing format similar to pregnancy tests or glucose testing.

Q: What has been the biggest challenge in developing this technology?

A: The biggest challenge was to find a solution that can be low-cost and portable but still can provide HIV testing results rapidly. Luckily, we were able to develop a microfluidic device that can handle a small volume of blood and do sample preparation and amplification all on a single chip.

Q: Your chip is designed to test for HIV-1, the most common strain of HIV. Can it differentiate between the genetic variants of HIV-1?

A: Right now, we are targeting to develop a single test that can detect multiple strains of HIV-1. The device design offers multiplexing capabilities that can be explored in the future.

Q: Past HIV self-testing kits have suffered from increased rates of false positives when self-administered versus administered by a trained provider.1 How does your self-test minimize the risk of false positives?

A: The past HIV self-testing kits target antigen/antibodies, and these antibodies can often provide false positives. The test we are developing is highly specific as it utilizes carefully designed primers that target HIV RNA and we do not expect false positive results.

Q: Do you have plans to obtain approval from the FDA or any other government body?

A: Yes, that’s on the table. Once we validate our device with a large cohort of clinical samples covering multiple sub-types of HIV, we will be in a position to proceed to FDA approvals.

Q: Once commercially available, how do you envision the distribution of these tests to developing countries?

A: We expect to partner with companies with large networks of already established distribution centers throughout the developing world. We envision collaborating with the World Health Organization to facilitate distribution of these HIV self-tests around the developing world.

References:

Hurt, Christopher B and Kimberly A. Powers. “Self-testing for HIV and its impact on public health.” Sexually Transmitted Diseases. January 2014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4005336/

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Waseem Asghar, PhD, is working as an associate professor at the Department of Electrical Engineering and Computer Science, Florida Atlantic University, and director of Asghar Lab: Micro and Nanotechnology in Medicine. Previously, he held postdoctoral appointments at Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology, Harvard University, and Stanford School of Medicine as research fellow before joining FAU. His research interests lie in the areas of point-of-care medical devices, biosensors, smartphone-based imaging, microfluidics, and wearable devices. Asghar has published over 73 peer-reviewed journal papers and over 50 conference proceedings. He has received various international and national awards, such as the 2022 Distinguished Engineering Educator Award, the Engineers’ Council; 2020 NSF CAREER Award; 2020 New Faculty Researcher Award by ASEE SE; 2020 Researcher of the Year Award by FAU; 2018 Outstanding STEM Educator Award, by The Engineers’ Council; and international 2016 Humanity in Science Award. His research work has received excellent medi