Entries in In-Home HIV Test (2)


Home Testing for HIV: Reading the Lines in Do-It-Yourself Test

OraSure Technologies, Inc./Getty Images(NEW YORK) -- Do-it-yourself home testing for HIV, the virus that causes AIDS, has arrived.

The OraQuick In-Home HIV Test, the only one approved for over-the-counter use by the Food and Drug Administration that captures testing and results in one sitting, hit drug-store shelves two months ago.  An earlier HIV home test, called Home Access, required a user to prick a finger with a spring-loaded lancet, collect a drop of blood on a test card, mail it to a lab and call in a week for the results.

Aimed at those who might have avoided getting tested in the past either out of fear, stigma, worries over confidentiality or inconvenience, the new home test has been hailed as a breakthrough.

"It's hard not to be fully enthusiastic about the test," said Dr. Myron Cohen, director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill.  "Everything we do to increase testing has to have some degree of benefit.  By identifying and treating people early, we preserve normal life span and excellent health and reduce contagion."

But the new home test, which sells for about $40 and can also be bought online, has generated its share of hand-wringing, too.

"We generally like this thing," said Dan Tietz, executive director of the research and advocacy group AIDS Community Research Initiative of America, or ACRIA.  "It decreases some of the barriers to testing.  It kind of puts HIV in front of people, but there's a bunch of cautions."

For one, there's what Tietz called the "freaking out by themselves problem."  For the first time, there's no live counselor present -- not even a voice over the phone -- to deliver the results, offer support and make referrals.

In lieu of an in-person counselor, OraSure Technologies, which makes the OraQuick test that the FDA approved in July -- has set up a toll-free 24/7 customer support center with bilingual reps (English-Spanish).  They're not certified counselors but have been trained to answer questions about HIV/AIDS, explain how the test works and what the results mean.  

They can also hook up callers to counseling and care, using the Centers for Disease Control and Prevention's National Prevention Information Network and the HIV Medicine Association, and can also transfer callers directly to a health care professional or agency, said Ron Ticho, senior vice president for corporate communications at OraSure.

"Our representatives go through more than 160 hours of training," Ticho said.

Test kits come with instructions, warnings and precautions.  Home-testers can find the same test information on OraSure's website, along with the same referral databases the call center uses.  But handing concerns about HIV over to a toll-free number has raised questions.

Much is made of the fact that without a counselor present, even with warnings on the box and inserts and brochures written for a seventh- to eighth-grade reading level, home-testers might not understand that, as with all HIV tests, regardless of the testing method, a positive result is preliminary and needs to be confirmed by a more specific test given at an HIV test site.

This is especially worrying with the home test because although the OraQuick test is the same rapid test that medical professionals have used at testing sites since 2004, it loses some of its accuracy in the hands of consumers.  The percentage of results that will be accurately positive drops from 99.3 at a testing site to 92.9 when do-it yourselvers test themselves at home.  This means that about one person in 12 could get a false negative.

Another stumbling block is the "window period" -- the time it takes, usually 12 weeks, for the body to develop the antibodies the test detects after exposure to HIV, giving some people a "false sense of safety" that they're HIV negative when they are in fact HIV positive and at their most contagious.

OraSure emphasizes that its HIV home test is simply an additional option to the testing already available -- which often comes free -- at public health clinics, community service organizations and doctors' offices.

"We know that there's a lot of individuals who should be getting tested but aren't, and this is another opportunity for them to do so," OraSure's Ticho said.  "Is it the right option for everyone?  Probably not."

Copyright 2012 ABC News Radio


FDA Advisory Panel Approves Home HIV Test Kit

ABC News Radio(WASHINGTON) -- Americans are a step closer to being able to quickly determine in the privacy of their own homes whether they’re infected with HIV, the virus that causes AIDS.

An advisory panel to the U.S. Food and Drug Administration Tuesday voted 17-0 in favor of approving the OraQuick In-Home HIV Test, which produces results within 20 minutes of a quick swab along the gum line. A positive test result still must be confirmed with a traditional blood test performed in a laboratory.

The FDA, which isn’t bound by the recommendations of its advisory panels, is expected to make a final decision about the home test this year. A thumbs-up for the over-the-counter test kit from OraSure Technologies Inc., of Bethlehem, Pa., has the potential to reduce the number of people who unknowingly spread the virus because they’re unaware they’re infected. An estimated quarter million Americans are HIV-positive, but haven’t been tested. Each year, about 50,000 Americans become infected.

The FDA has estimated that 2.8 million people might test themselves in the first year after the over-the-counter test becomes available. FDA projected that the test could pick up 45,000 infections that otherwise would have remained undetected, while missing 3,800 infections, based upon the test’s 93 percent rate of correctly identifying infections in clinical trials. In addition, the agency estimated that by identifying 45,000 HIV-positive people, the test could prevent them from unwittingly transmitting it to another 4,000 people.

“This is a big step forward for HIV prevention. Anything that encourages people to get tested is a good thing,” said Dr. Richard Besser, ABC News chief health and medical editor, and a former acting director of the federal Centers for Disease Control and Prevention. “Twenty percent of Americans with HIV don’t even know it. It’s hard to prevent the spread if you don’t even know you’re infected. HIV is now a treatable as well as preventable disease.”

Besser said it’s important that anyone who gets tested, whether at home or in a doctor’s office, “is connected to support services.”

Copyright 2012 ABC News Radio

ABC News Radio