March 26, 2004 -- Federal regulators announced the approval of a rapid oral HIV test on Friday, saying that the move would help to widely expand AIDS screening.
The test samples saliva from a subject's mouth and can offer results in as little as 20 minutes. Officials said that the kit, called the OraQuick Rapid HIV-1/2 Antibody Test, could greatly cut down on the number of people who get tested for HIV but never return days later for laboratory results.
Approximately 25% of the 900,000 Americans with HIV don't know they have the virus, according to Department of Health and Human Services data. Meanwhile, as many as 30% of people who get tested for HIV never return to hear their results.
"The OraQuick test will almost certainly reduce that number," says Health and Human Services Secretary Tommy G. Thompson.
Thompson says the FDA gave the test an accelerated review in order to speed it to market.
The test will be available in about 40,000 hospitals and clinics with specialized labs nationwide, regulators say. The kit's manufacturer, OraSure Technologies Inc., says it will move quickly to spread the test to more clinics and eventually to sell the test over the counter.
The OraQuick test is similar to a rapid blood test that the company began selling in November 2002. Users swab their gums and insert the swab into a vial of solution. Reddish-purple lines in a small window on the kit indicate the presence of antibodies to the HIV-1 strain 20 minutes later.
HIV-1 is the strain that causes most infections in the U.S.
Jesse Goodman, MD, director of the Center for Biologics Evaluation and Research at the FDA, says that based on "limited" data the test can detect HIV antibodies in 99.3% of infected people. The test also avoids falsely identifying a negative person as infected 99.8% of the time.
"It's only early diagnosis that allows treatment to take place at an early and effective time," Goodman says.
OraQuick is not the first oral HIV test to come on the market. Abbott Laboratories gained approval for a test in the late 1980s, but the test was later pulled from the market after the FDA cited manufacturing flaws at the company.
R. Sam Niedbala, PhD, OraSure's chief science officer, says in an interview that the company would immediately begin applying to expand the test's availability, first to a broader range of clinics and health centers, and eventually over the counter.
Goodman says regulators must first evaluate the test to be sure that results that show false-negatives don't become a problem when thousands of persons use the test nationwide.
"We have to collect enough information to be sure you don't hurt the public health doing this," Niedbala tells WebMD.