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FDA approves first rapid, take-home HIV test

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Some HIV/AIDS experts and survivors insist for the first-time tester, the clinic is the best place

By Chris Levister

Americans will soon be able to test themselves in the privacy of their own homes for the virus that causes AIDS, now that the Food and Drug Administration has approved the first rapid, over-the-counter HIV test. The OraQuick test detects the presence of HIV antibodies using a mouth swab and returns a result in 20 to 40 minutes.

Government officials estimate that about 240,000 people, or one-fifth of the roughly 1.2 million people carrying HIV in the U.S., don't know they are infected. Testing is a chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.

FDA officials said the test is designed for people who might not otherwise get tested. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. Orasure plans to start selling the test in October, both online and through retailers like Walgreens, CVS and Walmart.

It hasn't set a price yet but expects the consumer version to cost less than $60 but more than the one marketed to health professionals, which costs about $17.50. CEO Doug Michels said the price increase will help pay for a toll-free call center to provide counseling and medical referrals to test users.

The company's marketing efforts will focus on populations at greatest risk of being infected with HIV, including gay and bisexual men, African Americans and Hispanics. Over 46 percent of Americans who have been diagnosed with HIV since 1981 have been African American. And although AIDS diagnoses and deaths have declined substantially in the United States since the mid-1990s with the advent of highly active antiretroviral therapy (HAART), African Americans have continued to be diagnosed with HIV/AIDS in numbers disproportionate to their percentage of the population.

The FDA stressed in its approval announcement that the test is not 100 percent accurate in identifying people with the virus. A trial conducted by test maker Orasure showed OraQuick detected HIV in those carrying the virus only 92 percent of the time, though it was 99.9 percent accurate in ruling out HIV in patients not carrying the virus. That means the test could miss one in 12 HIV-infected people who use it but would incorrectly identify only one patient as having HIV for every 5,000 HIV-negative people tested, the FDA said.

People who test negative should get re-tested after three months, because it can take several weeks for detectable antibodies to HIV to appear, according to Dr. Jonathan Mermin, director of the Centers for Disease Control and Prevention's HIV unit. The FDA has approved several other HIV test kits designed for home use, but they usually require a blood sample that must be sent to a laboratory for development.

HIV awareness groups hailed the approval as an important step in expanding testing for the virus. "This test will allow anyone to empower themselves to know their HIV status when, how and with whom they want to," said Tom Donohue, founding director of Who's Positive. But some HIV/AIDS experts and survivors say OraSure could lead to more people knowing their status but fear those who learn they have the virus won’t get counseling, care. Carla Bailey is a mother of six who has been battling full blown AIDS since 1992. When she first tested positive all sorts of things went through her head. “Well, first, it was an extreme sense of denial, that I wasn't infected, that there was a serious mistake because I had no symptoms. I guess my first rational thoughts were ‘oh my God my whole world is crashing’,” said Bailey. “I was in a state of shock. I couldn’t even bring myself to tell my family – I lapsed into a state of severe depression for three years.

Initially, we lost everything - house, cars, all of it. I lost my job, I couldn't work. It was quite literally a living hell,” she said. “I was having trouble with medications, I was lucky to have my older sister, who is a health care professional and she walked me through a lot of this stuff, even the crying in the middle of the night.

A diagnosis of HIV is not the kind of news you want to learn at home in your bathroom with no available counseling care.” Bailey says despite her concerns, the hope is in-home testing could lead to more people knowing their HIV status and, in turn, earlier intervention. “I strongly encourage people to get tested – that said, one size does not fit everyone. If you choose not to go to a clinic, have a family member or close friend at your side when you do the first home test.”

Bailey says she fears a dangerous disconnect if people get a positive diagnosis and don’t follow up with a confirming blood test. On the other hand she said a negative result could lead to a false sense of security. “It’s a slippery slope.”

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