This Is Only A Test

Between the waiting, anxiety, and denial, there are several reasons why some people don't get tested for HIV. OraQuick may change that.

BY Michelle Garcia

June 26 2012 12:00 AM ET

Between the waiting, anxiety, and denial, there are several reasons why some people don't get tested for HIV. OraQuick may change that. In May, an independent Food and Drug Administration panel unanimously concluded that OraSure Technologies Inc.'s over-the-counter, at-home rapid HIV test would be safe and effective to sell to consumers. All 17 members of the Blood Products Advisory Committee agreed that the OraQuick In-Home HIV Test would encourage more people to know their status and therefore take preventative 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. So far, the company has sold nearly 25 million tests to hospitals, community-based organizations, medical clinics, and physician offices. One hurdle for the at-home test, however, is its rate of accuracy. Currently the test administered by medical professionals is 99% accurate, but the consumer version has a 93% accuracy rate. The panel recommended that the test come with a warning that the results may not be completely accurate. According to the panel, the test would miss about 3,800 HIV-positive diagnoses a year, but correctly identify 45,000 people. This 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 like Home Access Health Corp.'s Express HIV Test System require users to send blood samples to a lab. 'We shouldn't let the perfect be the enemy of the good and this is an additional option,' Francisco Rentas, a panel member and director of the Armed Services Blood Program, said after the vote, according to BusinessWeek. FDA regulators will soon determine whether OraQuick will be sold as the first FDA-approved at-home rapid HIV testing kit available in the United States. OraSure Technologies Inc. estimates that the test would retail for less than $60 without a prescription if officially approved and made available within the next few months.

Quantcast