Quick Swab, Quick Results

The waiting period, anxiety, and denial are among the many reasons some people don’t get tested for HIV. OraQuick, which is considered by many to be the next step in the fight against the virus, may change that In July, the Food and Drug Administration approved OraQuick, the first at-home test that will let users learn their HIV status right away—just like with a pregnancy test.

The FDA agreed that the OraQuick In-Home HIV Test would encourage more people to learn their status and, if they’re positive, take preventive measures to ensure they don’t spread HIV. The Centers for Disease Control and Prevention estimates that 20% of Americans with HIV, or about 240,000 people, are unaware they are positive. Because these people don’t know their status, they cause between 54% and 70% of new HIV infections each year.

The new product is a version of the professionally administered OraQuick Advance Test, an oral swab that provides results in 20 minutes, which the FDA approved in 2004. Since then its maker, OraSure Technologies, has sold nearly 25 million Advance Tests to hospitals, community-based organizations, medical clinics, and physician offices.

OraSure Technologies CEO Douglas Michels said the at-home test, which is expected to cost less than $60 at pharmacies and other retail outlets, will be a breakthrough in health care.

“For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed,” Michals said. “This new in-home rapid test—the same test doctors have used for years—will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting.”

One problem with the at-home test, however, is its accuracy. Currently the test administered by medical professionals is 99% accurate in detecting HIV, but the consumer version has a 93% accuracy rate. The test would miss about 3,800 HIV-positive diagnoses a year but correctly identify 45,000 people with the virus.

“We shouldn’t let the perfect be the enemy of the good, and this is an additional option,” Francisco Rentas, director of the Armed Services Blood Program and a member of an FDA advisory panel that recommended approval of the test, according to Businessweek. The product will come with an information sheet noting that it may produce some inaccurate results and urging users to follow up with a doctor, and OraSure will make counselors available by phone around the clock.

The home test could still prevent 4,000 new transmissions of the virus each year, based on sales projections. And there is demand for an easily available rapid test. A recent study found that 84% of gay and bisexual men say they would administer a self-test if a proper kit were available. The other available at-home kits, such as Home Access Health Corp.’s Express HIV Test System, require users to send blood samples to a lab, while OraQuick’s results are available almost immediately.