A new over-the-counter test for HIV that people can use in the privacy of their homes could boost detection of the virus, but also leave the newly diagnosed without crucial counseling, according to Maine HIV/AIDS prevention groups.
The OraQuick test, approved last week by the U.S. Food and Drug Administration, uses a mouth swab and produces results within 20 to 40 minutes. It’s expected to hit drugstore and supermarket shelves, as well as online retailers, by October.
Another HIV home test was previously available over the counter that required users to prick a finger and mail a drop of blood to a lab for testing.
The OraQuick test, available without a prescription, likely will appeal to those reluctant to visit a clinic for testing, said Patti Capouch, executive director of the Frannie Peabody Center in Portland, an HIV/AIDS organization serving Cumberland and York counties.
“There are some people that don’t want to come into a facility and do it; they’d rather do it at home,” she said. “If that gets more people to test, that’s great, because everybody should know their status.”
Of the roughly 1,500 people living with HIV and AIDS in Maine, it’s estimated that several hundred don’t know they’re infected, said Sean Weber, program manager at Eastern Maine AIDS Network. OraQuick may be especially welcomed in rural parts of the state located far from clinics that test for HIV, he said.
Despite the benefits of the home test, Capouch said she’s worried that those who get a positive result won’t be connected with a local doctor, as they are when they’re tested through her organization and others in the state.
OraSure Technologies, the Pennsylvania company that manufactures OraQuick, plans to staff a 24-hour hotline to help consumers administer the test and offer guidance on what to do after learning the results.
It remains to be seen whether the hotline’s staff will be well-informed about HIV/AIDS resources in Maine, Capouch said.
“Getting a positive result is really something you need a professional to talk you through and help link you to medical care,” she said.
The test detects the presence of antibodies to the human immunodeficiency virus, which causes AIDS. When administered by consumers, researchers found the test to be accurate 92 percent of the time in people who have the virus, versus 99.98 percent of the time in people who are not infected.
In other words, about one person in 5,000 would get a false positive result, while about one in 12 could get a false negative, according to an FDA press release.
A positive test should be followed up with additional testing in a doctor’s office to confirm, the agency said.
A version of the test was approved for use by trained technicians in 2004.
Because it can take up to three months for antibodies to develop after a person is infected with HIV, people who use OraQuick may not know they’re testing too early, Weber said.
He’s anxious to see how clear the test’s instructions are and worries that people may miss out on important HIV/AIDS education, he said.
“We talk to them about things like safer sex, abstaining, not sharing drugs, all that stuff that puts them at a higher risk,” Weber said. “That’s where we’re a little leery, because they’re not going to get any pre- and post-test counseling. And are they going to be doing the test correctly?”
The test is expected to cost less than $60. Weber’s organization charges $30, “but we still test them if they don’t have the money,” he said.
As of May, Maine recorded 23 new cases of HIV/AIDS across the state, Weber said. That doesn’t include three new positive cases his organization has seen over the last few weeks.
Nationally, about 50,000 new cases of HIV are reported every year, many transmitted by people who don’t know they’re infected, according to the U.S. Centers for Disease Control and Prevention.