FRIDAY, March 26, 2004 (HealthDayNews) -- The U.S. Food and Drug Administration on Friday approved the first oral HIV test, which gives results with 99 percent accuracy in only 20 minutes.
The test, called OraQuick from OraSure Technologies, analyzes mouth cells collected with a swab to see if antibodies to the HIV-1 virus are present. It behaves something like a pregnancy test: if the results are positive, two reddish-purple lines show up in a small window on the device.
People who test positive, however, will still need a laboratory test to confirm the results. HIV-1 is the most common form in the United States of the virus that causes AIDS.
The new test is "going to have a tremendous impact. Anything that removes any barrier and makes it easier and more user-friendly" is a boon to fighting HIV, said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.
Given the ease of use, the device is expected to encourage more people to get tested, although how soon that will happen is still an open question. A law restricts who can use certain types of medical tests, according to the Associated Press, and it will take a waiver of that law for the oral test to be allowed in the same settings as other HIV tests are.
"A lot of HIV testing happens in small clinics and, right now, there isn't a waiver, so this can only be done in larger facilities such as teaching hospitals and so on," said Dr. Tyler Curiel, chief of hematology and medical oncology at Tulane School of Medicine in New Orleans. "It's certainly going to be a help, but until they can get a waiver, I'm not sure a large additional pool of patients will be detected. It's still convenient and better than having a needle stick."
Once the company gets a waiver, Curiel added, "I think a lot of people are going to be inclined to get the test."
Testing is crucial, not only so HIV-positive individuals can get treated, but also so they can prevent transmission of the virus to others.
According to the U.S. Centers for Disease Control and Prevention, about a quarter of the estimated 900,000 people infected with HIV in the United States do not know they are infected. About 40,000 additional people are infected in the United States each year, says the AP.
Existing HIV tests can give results in a matter of minutes, but require a small sample of blood, usually obtained by pricking the finger.
The original rapid test, the OraQuick Rapid HIV-1/2 Antibody Test, which is also made by OraSure, was approved in November 2002.
Both the original test and the new one detect antibodies to HIV infection. And both tests can be stored at room temperature and do not require any special equipment. The newer test is safer for health-care workers because it requires no needles.
"It's simple and easy with no issue of potential blood exposure," Goodman explained.
"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," Tommy G. Thompson, secretary of the U.S. Department of Health and Human Services, said in a statement.
"Where the rapid test is available, those tested get their results within minutes. This oral test provides another important option for people who might be afraid of a blood test. It will improve care for these people and improve the public health as well," Thompson added.
According to the AP, both the new and original OraQuick tests will sell for about $8 per test for public health officials and $8 to $20 for other organizations, depending on how many are sold. The CDC is likely to be a major customer.
While the test can only be used in large medical facilities to begin with, that is likely to change, and acting FDA Commissioner Lester M. Crawford has urged OraSure to apply for a waiver.
Goodman said the FDA would give any such request "high priority," noting that when the same company applied for a waiver previously, it was only a matter of months before it was granted.
More information
For more on HIV testing, visit the U.S. Centers for Disease Control and Prevention or
National HIV Testing Resources, a service of the CDC.
