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FDA Approves Over-the-Counter In-Home HIV Test

HIV Testing Access Problems Persist

By J. Carlton Zeigler for Healthy Living News

The U.S. Food and Drug Administration (FDA) has approved the first rapid over the counter HIV test for sale directly to consumers. The OraQuick In-Home HIV Test can detect antibodies to HIV with an oral swab, providing a confidential testing option with results in around 20-40 minutes.

According to the FDA, a positive result from the test does not mean that an individual is definitely infected with HIV, just that additional testing should be done to confirm the results.

Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, especially if exposure may have been within the previous three months.

The test has the potential to identify many previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods. Most HIV testing is done in a clinical setting where counseling is also provided.

The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States have HIV. However, about one in five are not aware of it. It’s they who may be largely responsible for the 50,000 new HIV infections that occur in the U.S. each year.

“We set out with a clear purpose – to dramatically impact the number of people getting tested for HIV,” said Douglas A. Michels, of OraSure Technologies. “OraQuick brings us much closer to accomplishing that goal.”

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” added Karen Midthun, M.D., of the FDA. “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.”

The test is not 100% accurate however. For HIV-infected individuals, the clinical studies revealed one false negative result per every 12 tests. For uninfected individuals, the number of false positives was far lower. There was about one among every 5,000 tested.

The OraQuick In-Home HIV Test is expected to be available for purchase this October. A “live” toll-free consumer call center and website will be available. The bilingual call center (English/Spanish) will be confidential and will operate 24 hours a day, seven days a week.

“Many additional access points to testing are optimal.” said Minister Franklin Hobbs, founder and director of Healing Our Lands and long-time HIV activist and survivor. “There are people who need additional privacy who would not access traditional HIV testing points or locales.“

The retail cost of the test has not been announced but it could initially be as high as $60 per kit. The packaging and live customer support account for the steep price. That could make the test too costly for some HIV at-risk individuals and so reduce its usefulness as a diagnostic tool.

A 2006 Annals of Internal Medicine study did show that HIV home testing will attract an “affluent clientele” who are not really at high risk of contracting HIV. According to the report, that may increase overall false test results but not lead to any significant decrease in the number of those who don’t know they have the virus.

On the other hand, the excitement surrounding recent treatment as prevention breakthroughs could lure at-risk, test leery individuals into trying the new test. That is if they can afford to purchase it.

The in-home test also comes at a time when the CDC is being forced to direct funding for HIV testing and other prevention programs to states with high HIV transmission rates. That leaves many clinics in other states without the funding for HIV or even STD testing. Insurance plans under the Affordable Care Act (“Obamacare”) are now required to cover these tests in a clinical setting. But that is only for those with health insurance. This is resulting is an HIV testing-access-gap in some parts of the country that will not be readily filled by an expensive in-home test.

“I am concerned that overpricing home-based tests and defunding other proven testing methods is just another example of privatizing, or outsourcing efforts, to fight a public health emergency,” said Kim Sue of the AIDS activist group, ACTUP/Boston. “This indirectly shortchanges poor, HIV-impacted, communities most in need of having access to subsidized home HIV tests and reliable connections to care.”

Other home screening tests are available for over the counter or online purchase. Some, however involve sending a blood sample to a lab. The user usually gets the results by calling a laboratory in a few days to a week. The cost of those tests vary at about $40 to $60 dollars.


Q&A: The FDA On the Impact of The New In-Home HIV Test.

Q: What do you see as the biggest impact OraQuick will have on HIV testing?
A: This test is targeted to people who would not otherwise be tested. There’s a large group of people who are infected, and don’t know it. And even if they are engaged in behaviors that would put them at risk of getting HIV, they may be reluctant to visit their doctor or a health care facility on be tested.

Q: Why did FDA approve this test?
A: FDA predicts that the availability of the OraQuick In-Home HIV test will contribute measurably to public health by helping more infected individuals to become aware of their HIV status and thereby reducing HIV transmission.

Since 2002, FDA has approved a number of rapid HIV tests (tests that require no special equipment and provide results in as little as 20 minutes) that can be used by trained individuals outside of a traditional laboratory or clinic. The OraQuick In-Home HIV Test provides another option for people who might be unlikely to go to a health care setting for this testing.

Q: Are there any other FDA- approved home test kits for HIV?
A: In 1996 FDA approved a home specimen collection system called The Home Access HIV-1 Test System. This system involves the collection of a spot of dried blood that is then sent to a laboratory for analysis. The user gets the test results anonymously by calling the laboratory in a few days. However, OraQuick is the only test available that allows the users to collect the sample and obtain a preliminary test result themselves.

Q: How does the test work?
A: The test checks for antibodies to HIV. You swab your upper and lower gums for an oral fluid sample with the test device. That device is placed in a tube with a developing solution. After 20 to 40 minutes, one line will appear if the test is negative. Two lines indicate that HIV antibodies were detected HIV positive. Follow-up confirmatory testing is then needed.

Q: So if it’s positive, does that mean I definitely have HIV?
A: Not necessarily. What it does mean is that further testing is needed to confirm your HIV status. Look at this as a first step in HIV testing. No test is perfect—there will be false positives. Clinical studies show the new test will produce one false positive result out of about every 5,000 tests in uninfected individuals .

But if you get a positive result, it’s very important that you see your healthcare professional or call the OraQuick Consumer Support Center, which has counselors available 24 hours a day to answer questions and provide local referrals for follow-up testing and care.

Q: And if it’s negative, does that mean that I definitely don’t have HIV?
A: No – and this is important for users of the test to understand. The test is not reliable at detecting HIV infection until at least three months after infection. In addition, even after three months, there can also be false negatives.

Q: If there are antibodies in the mouth, does this mean I can pass HIV by kissing someone?
A: The antibodies are the body’s reaction to the presence of the virus. They are not the virus itself. Body fluids that have been shown to contain high concentrations of the HIV virus are blood, semen, vaginal fluid, breastmilk and other body fluids containing blood. So, only if there is blood in the saliva (for example, due to a cut in the mouth) could saliva possibly contain sufficient virus to cause an infection.

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