FDA Panel Recommends Over-the-Counter At-Home HIV Test

WASHINGTON, D.C.—Despite concerns that public availability of an at-home test for HIV could lead people to engage in increasingly risky behavior, a 17-member advisory panel of the Food and Drug Administration has voted to approve the over-the-counter test, called OraQuick. The unanimous vote comes on the heels of the recommendation last week by the same panel that an HIV prevention drug in pill form, called Truvada, be approved. Truvada, unlike OraQuick, would require a prescription.

Produced by OraSure Technologies Inc., OraQuick is a take-home version of another FDA-approved HIV test called OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, which is conducted clinically and gets results in 20 minutes.

"The in-home test is a modified version where the individual swabs the upper and lower gums with a test pad device," reported CNN. "That device is then inserted into a vial of solution. Much like a pregnancy test, one line shows up if the test is negative, two lines means it's positive. The kit includes step-by-step instructions on when to test, how to set up and administer the test, and how to interpret the results. The company also provides information on how to follow up on the results through OraQuick's Answer Center for support, and local medical referral is also provided. The center is staffed 24 hours a day, 7 days a week."

But OraQuick is not perfect. In tests conducted by OraSure, the test correctly identified the presence of HIV 93 percent of the time, though the company also contended that "the test proved 99.98 percent effective in determining who did not have the virus."  With professionally-given tests, the percentage of false negatives is in the 3 percent range, said WebMD.

But those percentages were obtained in clinical settings and not at home. Once the anticipated approval goes through, it is expected that as many as 3,800 people who are infected will be told by the test that they are not.

On the flipside, according to WebMD, "The FDA calculates that in the first year after OraQuick is approved for home use, an extra 45,000 people will correctly learn they have HIV."

It is those numbers that prompted the 25 or so doctors and HIV/AIDS professionals to seek the panel's approval for the test, saying it was a big step forward for the country. According to the CDC, of the estimated 1.2 million people carrying the HIV virus in the U.S., about one-fifth, or approximately 250,000, are ignorant of the fact. New infections worldwide have held steady at around 50,000 per year over the past two decades.

"I can't get past the quarter of a million people in the U.S. who have HIV and are not tested," one of panel members, Dr. Steven W. Pipe of the University of Michigan, said at the meeting. "If we make any dent in that, the answer is yes, we realize the [OraQuick At-Home] benefit outweighs its risks."

"We are always looking for game changers, and we believe this is one of them," said Carl Schmid, deputy director of the AIDS Institute. "Not only will it help reduce the number of infections but it will bring more people into care and treatment."

Another anticipated benefit to the approval of the test is that it may change risky behavior, according to another panel member, Susan Buchbinder, MD, director of HIV research at San Francisco's health department and a long-time AIDS researcher.  

"A positive HIV test does reduce risk behavior. A negative test doesn't have much of an influence," she said. "We must assume there will be some incorrect results. The question is how do we help people understand a negative result might not truly mean a person is negative for HIV."

Not for Use in Porn

OraQuick is not recommended for use by everyone, however. Because the test detects HIV antibodies, which appear several weeks after an infection has occurred, it is decidedly not for use by anyone in a high-risk category, including adult entertainment performers.

According to WebMD, "A recent study suggests that rapid HIV tests such as OraQuick will be accurate two months after infection. OraSure says that to be safe, people should assume the OraQuick test will miss any new HIV infection contracted in the past three months.

"This means that people with any HIV risk behavior—such as unprotected sex or needle sharing—will need regular retesting, as is true with any HIV test. And confirmatory testing at a doctor's office or free clinic is strongly advised for those who test positive but also for those who test negative despite high-risk behavior."

That said, with the FDA panel's approval of both this test and the HIV prevention pill, Truvada, new tools are being deployed in the war against not only HIV/AIDS itself, but the fear and state of denial that has accompanied the virus ever since it first reared its ugly head. Whether people use these new diagnostic and prevention methods, and use them properly, remains to be seen.