THE VIRGINIAN-PILOT
Copyright (c) 1994, Landmark Communications, Inc.
DATE: Saturday, December 24, 1994 TAG: 9412240313
SECTION: FRONT PAGE: A2 EDITION: FINAL
SOURCE: LOS ANGELES TIMES
DATELINE: WASHINGTON LENGTH: Medium: 58 lines
The Food and Drug Administration Friday approved the first AIDS test that uses saliva - instead of blood - to determine whether a person has been infected by the virus.
But the agency warned that the saliva test is not as accurate as the current tests that use blood, and recommended blood tests to confirm the presence of the virus.
The approval is expected to be welcomed by much of the AIDS community because it provides an option that may encourage more individuals to be tested, particularly those who are reluctant or fearful of having blood drawn.
``Anything that makes it easier to get tested and speeds diagnosis is a good thing,'' said Dr. Mervyn F. Silverman, president of the American Foundation for AIDS Research.
The test, which will be sold under the brand name of OraSure, is manufactured by Epitope Inc., of Beaverton, Ore. Company officials said they expect the test to be available within six weeks.
It is believed to be the first such test approved by the FDA that uses oral specimens in disease detection. Like the blood test, it detects antibodies to the virus.
The company predicted the technology would be applied in the future to test for additional diseases, such as measles and hepatitis, and to aid in the monitoring or detection of drugs.
The test must be administered by physicians, and is not available for home use, said the FDA, which is still deliberating whether to approve a blood test that can be conducted at home.
The OraSure device consists of an absorbent pad mounted on a lollipop-style plastic stick. The pad, treated with a salt solution to enhance collection of antibodies in the oral cavity, is placed between the lower cheek and gum for two minutes. The fluid specimen is then placed in a sealed vial that contains a preservative solution and sent to a lab for analysis.
The cost of the device will be about $2 to $4 a unit, excluding the laboratory analysis, a company spokesman said. He estimated that lab costs will add an additional $3 to $15 a test. The standard blood tests that detect HIV antibodies cost about $30.
The FDA cautioned that the saliva test may miss one or two infected individuals per 100 infected people tested, and may also result in false positives at the same rate in the uninfected. For this reason, the agency recommended that those who test positive by saliva undergo confirmatory blood tests to establish true infection. MEMO: HOW IT WORKS
The test, which will be sold under the brand name OraSure, detects
antibodies to the HIV virus in saliva. The virus itself is not in the
saliva. by CNB