Implementing the Use of Rapid HIV Tests

By Marcus Stevenson, J.D., LL.M. candidate

The Public Health Service, specifically the Centers for Disease Control and Prevention (CDC), recently announced that it is recommending the use of Rapid HIV tests. Rapid HIV tests allow an individual to learn whether their immune system has begun to develop antibodies to HIV on the day they are tested. In fact, the test results may be available before the individual departs from the location where the test was given.

As of March 1998, Murex Corporation, in Norcross, Georgia, is the only company that has received the United States Food and Drug Administration’s (FDA) approval to commercially manufacture and distribute Rapid HIV tests. The product’s name is Single Use Diagnostic System for HIV-1 (SUDS). SUDS has been licensed for clinical use and can produce results in approximately five to thirty minutes. The sensitivity and specificity of SUDS is believed to be equivalent to existing HIV tests that employ enzyme immunoassay (EIA). The results of the SUDS test must be confirmed by a Western blot or immunofluorescence assay, which is standard confirmation for HIV screening tests.

At a cost of less than $10 per testing kit, Rapid HIV tests offer the possibility of screening larger numbers of people with a limited delay in the results. CDC officials believe that HIV prevention programs will be able to take advantage of Rapid HIV tests as more products are licensed and approved by FDA. Along these lines, however, the manner and timing of HIV counseling will be significantly altered. The CDC has identified several HIV counseling issues that will require integration and implementation by various public and private health care providers. In addition to counseling concerns, issues affecting program and clinic managers include:

    1. higher false-positive tests in patients from communities with low HIV prevalence and low behavioral risk factors;
    2. adequacy of laboratory personnel to perform the test;
    3. substantial increase in the cost of the Rapid HIV test when compared to traditional EIA tests;
    4. sufficiency of quality assurance programs and proficiency testing; and
    5. manner the test results will be evaluated.
As Rapid HIV tests are considered for use, and ultimately used, protection of patient confidentiality, informed consent, and infectious disease reporting requirements will be further complicated. Health officials are attracted to Rapid HIV tests because many people who now take the standard EIA test do not return to find out the results, use fictitious names, or do not avail themselves to counselors. Products such as SUDS offer the possibility of earlier detection, which allows for earlier and increased counseling on HIV and coping with a positive test result.

Laboratories that perform these tests will still be required to prove that their personnel are qualified to administer and evaluate these tests as expected by the Clinical Laboratory Improvement Act of 1988. Although FDA has been satisfied that SUDS meets the requirements for biologics products, little discussion has been directed toward implementing the use of Rapid HIV tests in state-sponsored HIV programs. The significance of this approach to HIV testing will be determined by how many people or programs take advantage of the technology and how effective programs are in integrating counselors into the testing environment. With the advent of speed comes the need to build in adequate protections for both the recipient and analyzer of Rapid HIV tests.

For further details regarding Rapid HIV tests, go to the Center for Disease Control and Prevention’s website at: www.cdc.gov/nchstp/hiv_aids/dhap.htm.

04/10/98