At Home HIV-Test Considered

OraSure take-home HIV test under FDA consideration

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Taking an HIV test is the first step to protecting yourself and others from the life-threatening virus. Soon, you might be able to learn your status in the comfort of your own home.

The U.S. Food and Drug Administration is currently reviewing the OraQuick In-Home HIV test, the first take-home test that allows individuals to learn their status without medical supervision.

It's like a home pregnancy test: the test's simple mouth swab takes only 20 minutes to give results.

"An at-home HIV test could be on the market, pending FDA approval."

In a review document, FDA advisors said that the OraQuick test, created by OraSure Technologies, Inc., could play a role in slowing the spread of HIV. But the review also raised concerns about consumers receiving false results.

In a clinical trial, the test gave accurate results 93 percent of the time. The FDA requires a 95 percent accuracy rate.

However, the test accurately identified users who did not have HIV 99 percent of the time.

The FDA review concluded that the benefits of a convenient at-home test would have to be measured against the possibility of false results. They estimated that there would be one false negative result for every 13 accurately positive results.

"There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status," the reviewers wrote. "However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected."

At-home HIV tests are already approved, but it requires a blood sample and must be sent to a laboratory to be analyzed.

The U.S. Centers for Disease Control and Prevention estimates that approximately 232,700 Americans have HIV but are unaware of their status. That translates to 25 percent of HIV-positive Americans.

Fifty thousand people are newly infected with HIV every year.

Getting more Americans tested is considered a crucial step in slowing the spread of HIV, and eventually ending the epidemic. Those who don't know that they are HIV-positive may be engaging in risky behaviors like unprotected sex or sharing needles, and unknowingly transmitting the virus to others.

HIV testing is widely available in clinics, and in many cases it is free, along with counseling. But an at-home test may provide an appealing alternative to those who are not going in to get tested.

It's not yet known when the FDA may decide on the fate of the test, but advocates for a rapid results, at-home test say the more options for informing people of their HIV status, the better.

Reviewed by: 
Review Date: 
May 14, 2012
Last Updated:
August 10, 2012