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Over-the-Counter HIV Test: Public Health "Triumph” or Risky Approach?


The OraQuick mouth-swab test for HIV may soon be available to the general public over the counter. An infectious diseases expert says this is needed because primary care isn't testing enough people for HIV.

In May, a Food and Drug Administration (FDA) panel unanimously recommended approval of the first over-the-counter HIV test, the OraQuick mouth-swab test, and the full FDA is expected to concur. The result could be a significant increase in the number of people with HIV who get diagnosed. One researcher estimated that the home test could help diagnose 45,000 cases of HIV a year and prevent about 4,000 new transmissions.

The test is identical to the version used by clinicians since 2004. It takes about 20 minutes to work, and is expected to cost about $18. In the manufacturer-sponsored study, it accurately detected the virus in 93% of infected individuals, although that sensitivity will likely increase in a community setting.

The test could be one of the most effective tools in the public health arsenal for preventing viral transmission, said Amy Nunn, MD, an assistant professor of medicine in the Division of Infectious Diseases at Brown Medical School in Providence, RI. Dr. Nunn focuses on HIV prevention. Studies find that an estimated 1 in 5 people infected with the virus do not know they are infected, yet they are responsible for about half of all new infections.1,2 In addition, nearly a third of all diagnoses occur late in the infection, just before AIDS develops, when early treatment is impossible (Figure 1).3

Individuals who know their status, seek appropriate treatment, and receive risk-reduction counseling could significantly reduce the spread of the virus, Dr. Nunn said. Yet more than half (55%) of adults in the US have never been tested for HIV, 77% of those aged 18-24. That’s despite  recommendations from the Centers for Disease Control and Prevention (CDC) that healthcare providers routinely test all adults, retesting high-risk individuals more often. Men who have sex with men (MSM) should be tested annually.3 Figure 1  Percentage of persons aged 18-64 years who
reported ever being tested for HIV (United States 2001-2009)
and percentage of AIDS diagnosis occurring within 12 months
of initial HIV diagnosis
(Source: Centers for Disease Control and Prevention)

Less Stigma

“I think (the test) would be a public health triumph if it is approved by the FDA,” Dr. Nunn said. The test also represents a victory for a major public health priority over the past 20 years - deregulating testing. Testing has been highly regulated since the epidemic began in the early 1980s, she said, because of the stigma associated with HIV infection. Back then, AIDS was a certain death sentence. Infected individuals lost their jobs, were kicked out of schools, and were treated as pariahs by communities and families. Thus, the tests were highly regulated to protect confidentiality and privacy, she said.

“But this a new day,” she said. Today, HIV-infected individuals who start treatment while still asymptomatic can have a normal life expectancy. In addition, mounting evidence finds that people should begin treatment immediately upon confirming infection to improve outcomes and reduce transmission. In fact, Dr. Nunn notes, receiving treatment reduces viral transmission by 96%.

Home testing is also of “symbolic importance,” Dr. Nunn said. “The more people that see it and the more it’s available, the less stigma” associated with the disease. That’s particularly important in the African-American community, which has the highest rate of HIV infection and still attaches significant stigma to the disease.

“Testing and treatment are the best intervention we have to reduce transmission,” she said. “The more we can get that into the hands of the patient, the better.”

Missed Opportunities

Research shows numerous missed opportunities for testing. In one study of MSMs in 21 cities (n=7,271), 39% had not been tested within the previous year as the CDC recommends; 16% of those with the virus had never been tested; and 44% of those who tested positive were unaware of their status. The results suggest that MSMs should be tested every 3 to 6 months, the CDC wrote.4

Dr. Nunn notes that some people are reluctant to ask for testing, while some doctors may not have the time or knowledge of the guidelines to recommend testing. That’s because, historically, testing was recommended only for high-risk individuals. “But there is a tremendous amount of data showing that risk-based screening is not effective,” she said. Plus, the pressure that primary care physicians see more patients in less time reduces the likelihood that they will offer testing and counseling. “The CDC recommendation that testing be integrated into primary care hasn’t happened,” Dr. Nunn said. “We need to put in the hands of consumers.”

Although the new test is 93% accurate, the FDA panel expressed concern over the rate of false negatives and whether patients with a positive test would follow up with clinicians.

“That is something to be concerned about,” Dr. Nunn admitted, “but the test is still highly accurate.” The FDA panel recommended that the labeling note that a negative test does not mean the person does not have HIV, and that it include a toll-free number so those who test positive can access care.

Assuming the test is approved, Dr. Nunn emphasized the role of the primary care physician in reminding all patients that it is available, even though most HIV diagnoses will continue to be made in the clinical setting. The home test, she said, is not a substitute for clinical testing, she said, “but it adds value to our existing set of tools.”



References1. Campsmith ML, Rhodes PH, Hall HI, et al. Undiagnosed HIV prevalence among adults and adolescents in the United States at the end of 2006. J Acquir Immune Defic Syndr. 2010;53(5):619-624.

2. Persons tested for HIV--United States, 2006. MMWR Morb Mortal Wkly Rep. 2008;57(31):845-849.

3. Vital signs: HIV testing and diagnosis among adults--United States, 2001-2009. MMWR Morb Mortal Wkly Rep. 2010;59(47):1550-1555.

4. HIV testing among men who have sex with men--21 cities, United States, 2008. MMWR Morb Mortal Wkly Rep. 2011;60(21):694-699

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