In just a few months, over-the-counter HIV tests will be shelved alongside cold medicines and skin creams at neighborhood pharmacies, with the FDA's approval this month of Oraquick, the first ever rapid, in-home test for an infectious disease.
"Our hope in approving the product is that more people will be able to test themselves and find out their HIV status," said Rita Chapelle of the FDA office of public affairs.
Joan Duggan, a physician at the University of Toledo Medical Center, the former Medical College of Ohio, is not convinced that Oraquick will make a dent in new infection rates.
"This test is a two-edged sword. It's a great thing to have available, but we have to be careful. There's a huge potential for misuse," she said.
Thousands of health-care professionals, including Dr. Duggan have administered an identical version of the test since 2004.
She demonstrated how to perform the test, moving a flat plastic wand under her lips to swab her upper and lower gums. She placed the moistened stick in a vial of fluid that detects the presence of HIV antibodies, and then she set a timer. Oraquick's digital reading reveals HIV status in about 20 minutes. One reddish stripe signifies a negative result. Two stripes mean the test is positive.
Currently about 1.2 million people in the United States are HIV-positive, but about one in five of them do not realize that they have the disease, according to the Centers for Disease Control. Often unknowingly infecting others with HIV, this population is disproportionately responsible for new HIV infections. Each year, about 50,000 people in the United States, or one every 10.5 minutes, contract HIV.
"If we want to end this epidemic, people have to know their HIV status and use the appropriate measures to stop transmission," said Dr. Duggan. For now, that requires visiting a clinic, an uncomfortable step that many avoid.
Jerry Kerr, the HIV prevention coordinator for the Lucas County Department of Health, said, "I know there are people who don't get tested because they don't want to talk about the kind of things that come up during an HIV counseling session, such as risks they've been taking.
"Some people don't want it written down anywhere that they even went for an HIV test. You hear horror stories, databases of people who are HIV-positive that are accidentally uncovered," he said.
Although health-privacy laws closely protect a patient's HIV test outcome, unreasonable fears that insurance companies or employers could obtain this information prevent some people from getting tested.
"There's stigma associated with HIV testing," said Tyler Andrew TerMeer, Director of the Ohio AIDS Coalition. People may speculate that a woman who enters a clinic has been sleeping around or a man who enters is a closeted member of the gay community, he explained.
He imagined that sex workers who are reluctant to discuss their illegal activities would prefer the privacy of an in-home test as well.
"I think there's also a group of individuals who feel safety is an issue and worry their partner would find out and become violent if they walked into a clinic," he said.
Beginning this fall, these individuals -- who otherwise would not subject themselves to testing -- can buy a discreetly labeled Oraquick kit at a price ranging between $18 and $60 at any of 30,000 retail stores, which include Walmart, CVS, and Rite Aid.
Preserving total anonymity, OraQuick reveals HIV status to the user alone. "But that's a preliminary test result that could turn out to be a false negative or a false positive," said Dr. Duggan.
Although the test is close to infallible when used by medical professionals, about 1 in 5,000 people using the test at home will get a false positive. An estimated one in 12 people who have HIV will receive a false negative.
Dr. Duggan said she worries in particular that Oraquick buyers will fail to understand that the body usually does not produce enough HIV antibodies for the test to detect until three months after infection.
Someone who takes the test right after contracting the disease would receive a negative result, giving him or her a false sense of security and possibly keeping him or her out of medical care longer.
During these first months, those with HIV are extremely contagious.
"No matter how many times I tell people that they have to wait a minimum of 90 days, they don't understand that window period," said Michelle Coutcher, a social worker who frequently administers Orasure's rapid test at the University of Toledo Medical Center.
"People are going to run out and use the test, and it's going to give them false hope," she said.
Dr. Duggan imagined many people would buy the test in a panic after risky encounters. "People are going to wake up in someone else's bed after a bender thinking 'Why did I do that?' and run out to get the test," she said.
"It clearly is paramount that people understand the window period," said Ron Ticho, Senior Vice President of corporate communications at OraSure Technologies, which manufactures Oraquick.
He said the company considered 32 variations of package labeling when deciding how best to communicate that critical message.
Even guaranteed correct test results, though, would not put an end to the potential problems faced by in-home users.
Ms. Coutcher worries how home users of HIV tests will react if the tests turn out positive.
"Who's going to be there to tell you it's going to be OK? Who's going to link you to mental health services, medications, physicians, and make sure to confirm that this truly is a positive?"
With early treatment and proper care, though, people who are HIV-positive have nearly normal life expectancies.
"The challenge is we don't have any mechanism in place for knowing they've tested positive and getting them into early care and treatment," said Mr. TerMeer, adding that misinformation about HIV abounds.
Orasure will set up a 24/7 telephone hot line in English and Spanish where staffers who have received 160 hours of training will answer questions from OraQuick users.
They will provide counseling and use the CDC's referral database to direct HIV positive toward care.
Mr. Kerr said he expected OraQuick, in a roundabout way, to prompt more people to seek help at his own clinic.
"When people decide whether they want to part with what could be up to $60, I think a lot of people will rethink it and come to our free rapid test sites," he said.
"People will be seeing the test there in pharmacies as … a reminder. It's going to create more awareness about HIV, and that's always a good thing," he said.
Contact Sophie Broach at: firstname.lastname@example.org, or 419-724-6210.