FDA Approves First At-Home HIV Test

An HIV test which can be performed at home has been approved by the FDA, potentially bringing diagnosis and treatment to many who might've otherwise remain undiagnosed.

This past May an FDA advisory panel unanimously approved a test for HIV that people can perform at home. Relatively easy to use, the at-home test could greatly increase the number of people being tested for HIV, and thus enable treatment for many who would otherwise remain undiagnosed.

The test, called OraQuick and made by Pennsylvania-based OraSure Technologies, works by detecting antibodies generated as part of the body’s response to HIV-1 or HIV2 viruses. A testing stick includes a flat pad at the end which the user uses to swab the upper and lower gums. The pad is then placed in a developer vial for 20 to 40 minutes after which, like a pregnancy test, one or two lines are formed: one line is negative, two lines indicates the presence of antibodies to HIV-1 and/or HIV-2. In addition to gum swabs, the test can be used to test blood from a finger prick.

Tests at the local clinic for HIV have been around since 2002 but still a large number of infected people go undetected. Many who are at risk for HIV are hesitant to go to the clinic for a test because of the stigma of even appearing as though they might have HIV. According to the Centers for Disease Control and Prevention (CDC), about 1.2 million people in the US have HIV, but about 240,000 of them are unaware that they are infected. With an at-home test that people can perform anonymously, the hope is that the disease will be detected in more people and earlier so that treatment can begin sooner.

The test is pretty reliable at detecting the disease, returning a false positive in just 1 in 5,000 tests (a 99.98 percent accuracy). Its false negative rate of 1 in 12, however, means a lot of people infected with HIV will still remain undiagnosed if they don’t followup on the OraQuick test with further testing. Still, the test’s effectiveness in detecting people with HIV will bring a lot of people to the clinic who would have likely sought medical help only after the disease had advanced.

The procedure above may seem simple, but OraSure’s president, Doug Michels, acknowledged that the tests might not be so straightforward to users. In earlier testing, OraQuick was found to be very accurate when conducted by medical professionals. When consumers ran the test, however, accuracy dropped. Because of the test’s complexity, the FDA has required that OraSure run a call center to support users, open 24 hours a day, 7 days a week.

OraQuick will be available at supermarkets and pharmacies this October for $34. But sales are approved only for those 17 years old and above. The age restriction is not due to social or medical concerns, but instead due to the fact that very few subjects between 14 and 16 were involved in the original trials.  The FDA thus considers the test unproven for that age group. OraQuick is available for advance purchase here.

HIV has claimed the lives of over 25 million people over the past three decades. The CDC estimates that about 50,000 new cases of HIV occur every year, but HIV is no longer the killer it once was. According to the World Health Organization it can take a person infected with HIV 10 to 15 years to develop AIDS. Effective treatment with antiretroviral drug, however, is delaying the development of AIDS and allowing people to live longer, healthier lives. Like the lab-on-a-chip that allows people in remote parts of the world to test for HIV and syphilis, OraQuick can save lives by giving people hesitant to go to the clinic a test they can perform relatively easily and in the privacy of their own homes.

[image credits: OraSure Technologies and Avert]
images: OraSure Technologies and Avert

Peter Murray was born in Boston in 1973. He earned a PhD in neuroscience at the University of Maryland, Baltimore studying gene expression in the neocortex. Following his dissertation work he spent three years as a post-doctoral fellow at the same university studying brain mechanisms of pain and motor control. He completed a collection of short stories in 2010 and has been writing for Singula...

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