U.S. Food and Drug Administration Approves Rapid Version of AIDS Test
November 8, 2002
On Thursday, the Food and Drug Administration approved a rapid AIDS test that public health officials hope will substantially increase the number of people seeking testing and decrease the number of tested persons who never return for their results.
The new OraQuick blood test produces results in about 20 minutes. When HIV antibodies are present, FDA officials said the test detects them 99.6 percent of the time, but they cautioned that positive results should be confirmed with a conventional lab test.
The fastest HIV test currently in use takes about 90 minutes. In practice, however, most people who seek AIDS testing are not given their results for a week or more. The new test must still be performed in a medical office and will not be available for home use.
About one-quarter of the 900,000 Americans with HIV do not know they are infected. About half of those seeking HIV testing at public health clinics do not return to learn their results. In about 10,000 cases each year, the test is positive but the tested person never gets the news.
"It is definitely a great step forward in terms of prevention," said Dr. Ronald O. Valdiserri, deputy director of HIV prevention programs at the CDC. "The whole idea of making testing more convenient as a general approach to HIV prevention is a good one."
At present, the new test can only be performed at sites with a laboratory that has been inspected and whose technicians have been trained in accordance with the Clinical Laboratory Improvement Act. However, a company can apply for a waiver allowing the use of relatively simple tests by people with minimal training. In an unusual move, the federal government Thursday asked OraSure, the new test's manufacturer, to apply for such a waiver.
"Then the test could be given in many more health care settings, perhaps even administered by social workers in HIV counseling centers ... so I ask them to please apply now," Tommy G. Thompson, secretary of Health and Human Services, said at a news conference Thursday.
11.08.02; David Brown
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.