Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SATURDAY, December 24, 1994 TAG: 9412270091
SECTION: NATIONAL/INTERNATIONAL PAGE: A-4 EDITION: METRO
SOURCE: Los Angeles Times and Associated Press
DATELINE: WASHINGTON LENGTH: Medium
But the agency warned that the saliva test is not as accurate as tests that use blood, and recommended blood tests to confirm the presence of the virus.
The FDA said studies show that for every 100 people infected with HIV, the saliva test will miss one or two. For every 100 people who are not infected, test results will be incorrectly positive for approximately two people, the agency said.
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.
Epitope has been seeking FDA approval of its saliva test for 31/2 years. The firm's profits took a beating as it awaited the federal action. In 1993, Epitope had an annual loss of $14.7 million, and earlier this month it announced a fiscal 1994 loss of $15.6 million.
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 certain therapeutic drugs and drugs of abuse.
Under the guidelines for approval, the oral fluid test is strictly forbidden for home use and cannot be used to screen blood donors. The test must be administered by physicians, said the FDA.
The OraSure device consists of an absorbent pad mounted on a lollipop-style plastic stick. The pad, which is treated with a proprietary salt solution to enhance collection of antibodies in the oral cavity, is placed between the lower cheek and gum for two minutes.
The cost of the device will be about $2 to $4 a unit, excluding the laboratory analysis, a company spokesman said.
by CNB