The Food and Drug Administration approved the first rapid oral test for the HIV virus that causes AIDS, health officials announced Friday, providing a new option for people nervous about blood testing.
The test, made by OraSure Technologies Inc., provides results within 20 minutes with 99 percent accuracy, according to studies. People who test positive will need another laboratory test to confirm HIV infection.
Until now the only other approved rapid HIV test, also from OraSure, required blood samples.
With the new alternative, health workers simply wipe a treated cotton swab along the gums and stick the swab into a special testing device for on-the-spot results. The new test also reduces the chances of health workers being exposed to the HIV virus through accidental needle pricks.
“This oral test provides another important option for people who might be afraid of a blood test,” Health and Human Services Secretary Tommy Thompson said in announcing the FDA’s approval. “It will improve care for these people, and improve the public health as well.”
No return trips
The original version of the rapid blood test was hailed when it hit the market in 2002 as a way to dramatically increase the number of people who knew they were infected with HIV.
Until then, routine HIV tests took up to two weeks to provide results.
"Before the approval of this rapid test in November, 2002, many people being tested for HIV in public clinics did not return for the results of standard tests," said Thompson. "Where the rapid test is available, those tested get their results within minutes.
The Centers for Disease Control and Prevention has estimated that one fourth of the approximately 900,000 HIV-infected people in the U.S. are not aware that they are infected.
An estimated 40 million people in the world are currently living with the HIV virus. Although new medications in the U.S. and other western countries have reduced the number of deaths from the virus, AIDS is the top killer in Africa and could infect more than 10 million people in China in the next decade if not aggressively confronted, health officials warn.
The OraQuick test has not been approved to screen blood donors or for home testing.
