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Approval of The First U.S. HIV Test System Using Oral Fluid Samples

Date: December 23, 1994
Source: Food and Drug Administration (FDA)

The Food and Drug Administration today announced that it has approved the first U.S. HIV test system using oral fluid samples. Until now, all approved HIV tests have used blood samples.

In approving this new HIV test system, FDA approved both a product for collecting specimens of oral fluid and a specific test used to analyze the specimens for the presence of antibodies to HIV, the virus that causes AIDS. The test system is intended for use in subjects 13 years of age or older. Use of the specimen collection product is subject to several restrictions.

This new HIV test system is not as accurate as the approved HIV-antibody tests used on blood. Studies show that for every 100 people infected with HIV, the oral-fluid-based 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 test system includes a specially treated cotton pad on a stick and a preservative solution in a plastic container. A trained collector instructs the subject to place the pad between the lower gum and cheek to obtain a sample of oral fluid. The pad is then stored in the preservative until the sample is processed and analyzed by a qualified laboratory using an ELISA test specifically licensed for testing oral fluid samples.

FDA approved this HIV test system with the following restrictions:

  • The test system is available for purchase and distribution only through physicians.
  • The test system may be administered only by individuals properly trained in its use.
  • The test system must not be provided to subjects for home use.
  • Testing of the oral fluid samples for HIV antibodies may be carried out only with the Oral Fluid Vironostika HIV-1 Microelisa System.
  • The test system may be used for diagnosis only and must not be used to screen blood donors.
  • Before the oral fluid specimen is collected, subjects must be given a "Subject Information" sheet.

The information sheet provides information about the reduced accuracy of testing oral fluid compared with testing blood and about the alternative of testing blood. Because there is currently no confirmatory test for use with oral fluid samples, the sheet informs subjects that if their oral fluid samples are found to be positive for HIV antibodies they should have blood samples drawn and tested with a licensed blood-based test to verify their HIV status. It also gives subjects information on how to reduce the risks of HIV infection.

The oral fluid sample collection kit for HIV testing is manufactured by Epitope Corporation of Beaverton, Ore., and is marketed under the name "OraSure HIV-1 Oral Specimen Collection Device." The Oral Fluid Vironostika HIV-1 Microelisa System approved to test specimens is manufactured by Organon Teknika Corporation of Durham, N.C.