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Independent Testing for Independence Day: FDA Approves Over-the-Counter Oral HIV Test

July 3, 2012

Independent Testing for Independence Day: FDA Approves Over-the-Counter Oral HIV Test. Image: courtesy of AP and OraSure Technologies, Inc.

Image: courtesy of AP and OraSure Technologies, Inc.

In the continued fight to stop the spread of HIV/AIDS, the federal Food and Drug Administration (FDA) recently approved a new weapon: an over-the-counter, oral-test for people to check their HIV/AIDS status. Designed by OraSure Technologies Inc., the test, called Oraquick, has been used for years by trained technicians to test for HIV/AIDS, but this is the first time it has been approved for people's use outside of a doctor's office. Test-takers simply swab the upper and lower gums of their mouths and are typically able to read their results within twenty to forty minutes, much like an over-the-counter pregnancy test.

Although the availability and accessibility of the test symbolizes an important step in HIV prevention and education, it is not always 100% accurate. In a company trial, the test produced false negatives roughly eight percent of the time, or misreading one out of twelve HIV-positive test-takers. Conversely, the test was also found to give false-positive readings in one out of 5,000 HIV-negative test-takers. The false negative results are especially troubling as a HIV-positive person who received a negative result may be more likely to engage in risky behaviors, such has having unprotected sex or sharing needles, believing that they are not carrying the virus. The over-the-counter results stand in contrast to the test's accuracy when used in a medical setting, citing its ability to accurately identify carriers and non-carriers nearly 99% of the time. Over-the-counter test-takers who receive a positive result are strongly encouraged to schedule additional testing with a doctor.

Despite the test's possibility of an inaccurate reading, it still wields an enormous power to stymie the stigma surrounding HIV/AIDS and HIV-testing. With the test's projected availability online and in 30,000 stores and pharmacies nationwide by October, it will likely reach people who may not get tested through traditional channels -- such as scheduled doctors office visits -- either due to financial constraints, lack of health insurance, or fear or stigma, potentially making HIV-testing as common and routine as testing for diabetes, heart disease, or other manageable illnesses. As Housing Works' Director of National Advocacy and Organizing Larry Bryant testified before an FDA panel in mid-May, it is important that people use every tool available to stop the spread of HIV and take full control over their HIV/AIDS status and risks, and this test is a momentous and positive step toward an AIDS free generation. Read more about Larry Bryant's testimony here.

The price of Oraquick is expected to be released this fall, and is also expected to be available worldwide shortly thereafter.

This article was provided by Housing Works. It is a part of the publication Housing Works AIDS Issues Update. Visit Housing Works' website to find out more about their activities, publications and services.
See Also
Quiz: Are You at Risk for HIV?
10 Common Fears About HIV Transmission
More on Home HIV Testing

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