2012-07-05 16:19:17

HIV Home Test Approved


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The Food and Drug Administration has approved OraQuick, a product that allows you to test for HIV in your own home. An over-the-counter test already existed but required you to prick your finger and send the blood sample to a lab.  But the new test allows users to take a swab from the inside of their gums and wait 20 to 40 minutes to see the results.

Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first American HIV blood test calls the news,“wonderful because it will get more people into care.” Mark Harrington, the executive director of the Treatment Action Group, (TAG), the independent AIDS research and policy think tank and advocacy organization,   agrees that, “[a]ny tool that speeds up diagnosis is really needed.” And Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research said,

“Knowing your status is an important factor in the effort to prevent the spread of HIV…. 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.”

At-home blood tests were developed in 1987 and OraQuick was developed in 2005, but the tests have been controversial from the start. The CDC warned that an increase in new patients would overwhelm health clinics. And AIDS patients advocates feared self-diagnosis, unaccompanied by counseling and explanations by health care providers, would lead to a surge in suicides. The first concern seems heartless and hardly insurmountable  and Harrington says the fears are  ”things of the past.”

The FDA acknowledges the potential for false positives and false negatives. In a Q & A Elliot Cowan, Ph.D., in FDA’s Division of Emerging and Transfusion Transmitted Diseases, explained that a positive result means,

“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 for self-testing have shown that the OraQuick test will produce one false positive result out of about every 5,000 tests in uninfected individuals.”

When asked if the test result is negative “does that mean that I definitely don’t have HIV?” Cowan explained,

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. Clinical studies by untrained consumers showed that the OraQuick test will produce about one false negative result out of every 12 tests performed in HIV infected individuals.

False negatives are potentially dangerous, because it can lead people to behave as if they are HIV negative. But clearly, the benefits of the test far outweigh the risks. Cowan says,

 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 to be tested. 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…. 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.

OraQuick will be available starting in October at more than 30,000 retailers and online. But the controversy isn’t over yet. The test will only be available to people 17 and older, since only a few younger people were included in the clinical trials. We will have to see if retailers require ID. If they do, younger people, who may be among the most reluctant or unable to get an HIV test outside the home, may be denied this potentially life-saving product.

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