Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
Associated Press - Saturday, December 24, 1994
The new test will be available only from physicians and administered only by people trained in its use, the FDA announced Friday.
Dr. Jeff Lawrence, a consultant to the American Foundation for AIDS Research, said the test using oral fluid could encourage people who would avoid blood tests to be tested for human immunodeficiency virus, or HIV, the virus that causes AIDS.
"As long as a positive test is followed up with a blood test and as long as there is appropriate counseling available, it is a reasonable thing to do," said Lawrence.
The FDA said that in trials, the oral fluid test had a 2 percent error factor in both positive and negative results.
"That is much, much poorer than with a standard blood test," Lawrence said.
Under the guidelines for approval, the oral fluid test is strictly forbidden for home use and cannot be used to screen blood donors.
Patient instructions accompanying the test warn that it is less accurate than blood tests.
The new test measures the presence in the saliva of the antibodies to the HIV virus. The virus itself has not been found in saliva.
The FDA approval actually involves two procedures: a way to collect and preserve the oral fluid, and a way to test the specimen in a laboratory for the HIV virus.
To collect fluid for a test, a specially treated cotton pad on a stick is placed between the lower gum and the cheek and allowed to absorb fluid. The stick then is placed into a plastic container with a preservative solution.
At a laboratory, the specimen undergoes an "enzyme-linked immunosorbent assay," or ELISA, test that is able to detect antibodies to HIV.
Positive tests are confirmed with a blood test called the Western Blot, which is more sensitive than the ELISA and is able to detect antibodies specific to HIV.
The oral fluid collection system is marketed by the Epitope Corp. of Beaverton, Ore., under the brand name "OraSure." The kit used to test the specimen in the laboratory is made by Organon Teknika Corp. of Durham, N.C., and is sold under the brand name "Oral Fluid Vironostika HIV-1 Microelisa System."
Copyright © 1994 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, Pacific Life Foundation, and donations from users like you.
Always watch for outdated information. This article first appeared in 1994. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1994. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .