Oral Antibody Test for HIV Approved for Consumers

A rapid mouth swab test to diagnose human immunodeficiency virus (HIV) infection is being available as an over-the-counter product.

The test is a noninvasive, quick, accurate way to test for HIV-1 antibodies without blood, needles, or lancets, only takes about 20 minutes and is a home version of a rapid HIV test already being used by health care professionals in community settings.


The US Food and Drug Administration (FDA; Silver Springs, MD, USA) have approved the OraQuick At-Home HIV test which was extensively tested before marketing. In clinical trials enrolling regular people at risk of HIV infection, some 7% of people with HIV infection are wrongly told they do not have HIV. With a professional test, that happens only 2% of the time. Studies show the test was less accurate when consumers used them, but the FDA says the benefits of expanding HIV testing outweigh that test accuracy. The OraQuick system draws HIV antibodies out of the tissues of the cheek and gum. The virus itself is rarely ever found in oral fluid.

The price tag of the at-home test has not yet been set but will be a good bit more than the USD 20 cost of the professional version. That is partly because it will come with a detailed instruction booklet, and because OraSure (Bethlehem, PA, USA) the company making the test, will set up a call center with trained counselors available 24 hours a day, seven days a week. Stephen R. Lee, PhD, OraSure executive vice president and chief science officer, said, "The price will be substantially lower than USD 60, probably nearer USD 35."

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. The US Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) estimates that there are 50,000 new HIV infections every year. About 1.2 million Americans are HIV-infected, and about one out of five do not know they carry the virus. Such people may be more likely to spread the virus than those who know they are infected.

Susan Buchbinder, MD, director of HIV research at San Francisco's health department (CA, USA), said, "A positive HIV test does reduce risk behavior. A negative test doesn't have much of an influence. 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."

Related Links:
US Food and Drug Administration
OraSure
US Centers for Disease Control and Prevention