Date: Tue, 3 Jan 1995 19:25:18 +0500
From: awilson@smtpinet.aspensys.com (Wilson, Anne)

     Centers for Disease Control and Prevention 
     National Center for Infectious Diseases 
     Division of HIV/AIDS
     Atlanta, GA
     December 1994
     
     
        Questions and Answers about the Saliva HIV Antibody Test
     
     
     1Q.  What is this new test using saliva?
     
     1A.  The Food and Drug Administration (FDA) has approved a 
     device to collect oral fluid for use with a laboratory test to 
     detect antibody to HIV.  This assay uses a special 
     collection device to obtain a specimen of saliva which is 
     then tested for HIV antibody.  The device resembles an 
     ordinary cotton swab in appearance.  No needles or skin 
     puncturing are required.
     
     
     2Q.  Is this test as good as the blood tests that have been in 
     use for years?
     
     2A.  Since confirmatory tests are not yet licensed for saliva, 
     any individual whose saliva tests reactive will still have 
     to have their blood drawn for follow-up testing.  Positive 
     results will continue to require blood testing for HIV 
     antibody.  CDC studies show that the sensitivity of a 
     correctly used saliva HIV antibody test is acceptable for 
     use in public health and clinical settings where follow up 
     serologic testing is in place.  
     
     
     3Q.  If you can do an HIV antibody test on saliva, then why isn't 
     HIV transmitted by kissing?
     
     3A.  This test detects HIV antibody which is a protein present 
     in saliva, even when HIV itself is not present in saliva.  
     Previous studies have shown that low levels of HIV can be 
     found in saliva especially when visible blood is present.  
     Although studies have not shown HIV transmission via contact 
     with saliva, the Public Health Service advises against deep 
     kissing with known infected persons because of a theoretical 
     risk of transmission.
     
     
     4Q.  Who will be able to use this test?
     
     4A.  The device will be sold to physicians who may train non- 
     medical persons to collect clinical specimens to evaluate 
     patients who consent to it.  Specimens must be processed in 
     a laboratory as blood specimens currently are.  This is not 
     a "home test kit."
     
     
     5Q.  How should this test be used?
     
     5A.  Persons who are tested for HIV antibody with this saliva 
     test should be given the same considerations as with any HIV 
     test.  They should consent to be tested and receive 
     appropriate pre and post test counseling.  All test results 
     should be kept confidential.
     
     
     6Q.  What counseling message should be provided to clients that 
     have a reactive HIV-1 saliva test?
     
     6A.  Clients who wish to be tested with the saliva HIV-1 test 
     should be counseled during the informed consent session 
     about the meanings of any possible reactive results.  Risk 
     behavior assessment and discussion about change in any risky 
     behaviors are critical parts of the counseling process.  
     Persons who receive a reactive saliva result should abstain 
     from sex (or use condoms if unable to abstain) and needle 
     use and not donate blood or tissue until results have been 
     confirmed with the use of routine HIV antibody blood tests, 
     e.g., ELISA and Western blot.  Follow-up counseling should 
     include the elements of appropriate medical and psychosocial 
     referrals.
     
     
     7Q.  How much will a test cost?  Will it be less than a blood 
     test?
     
     7A.  Prices will be set by the test kit's manufacturer, the 
     laboratory that performs the test, and the clinician who 
     collects the specimen or orders the test.  As with other 
     medical tests, prices are likely to vary widely.