The Department of Pathology and Laboratory Medicine

Volume 1, Issue 2
August/September 1995

SALIVA TEST FOR HIV:
Answers to Your Patients' Questions

Author:
Calvin Linneman, M.D., Professor of Internal Medicine, Infectious Diseases

The Food and Drug Administration has recently approved a saliva test for HIV antibodies that may be the first step toward future home HIV testing. The Orasure HIV I(r) oral specimen collection device is an absorbent pad on a plastic stick that is placed between the cheek and gum for two minutes to collect saliva. The pad is then placed in a vial and shipped to a central laboratory where HIV antibody testing is done. Although the FDA approval represents a significant step, it specifies:
  • The device can be made available only through physicians.
  • All positives must be confirmed with blood tests.
  • The device cannot be used for home testing.

The saliva test will not be useful for most physicians because blood collection is easy in the office setting and provides a definitive answer. The main advantage for a saliva test would be in special situations where blood drawing is not convenient, such as insurance examinations or for home testing.

Home testing may be approved in the future. Such testing could reach a part of the population that needs to be tested, but will not obtain it through physicians or health departments.

In addition to the approved saliva test device, several companies have developed home tests that involve blood collection by finger prick followed by shipment to a testing laboratory. If the test is positive for HIV, counseling is provided by telephone.

Field trials have shown that these blood collection devices work effectively in a variety of populations at risk for HIV. The FDA has, however, withheld approval for home HIV testing (using either saliva or blood) because of the serious implications of reporting a fatal disease by telephone.



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