CDC NATIONAL AIDS HOTLINE TRAINING BULLETIN #7 - May 27, 1992
Centers for Disease Control and Prevention

1. Is there a new, faster test for HIV infection now available?

The Federal Drug Administration has licensed a 10-minute diagnostic test kit which can be used by health professionals to detect the presence of HIV-1, the virus that causes AIDS. This new HIV-1 diagnostic kit will quickly and reliably detect antibodies to HIV-1. It can be used in doctor's offices, clinics, emergency rooms, small hospitals, laboratories, or other heath care settings where traditional HIV diagnostic test kits are impractical or unavailable.

2. How does the HIV-1 test kit work?

The diagnostic test is a manually performed, 10-minute immunoassay to detect antibodies to HIV-1 in human serum or plasma. It is performed by mixing a small amount of a patient's serum or plasma with an antibody reagent to which only HIV-1 antibodies will attach. When a special enzyme solution is added to the serum or plasma plus reagent mixture, the window at the bottom of the test cartridge indicates the result. The enzyme turns blue if the results indicate that antibodies to HIV-1 are present. As with other screening tests, positive results should be confirmed by additional testing with other licensed test kits such as the Western blot or immunofluorescence assay (ELISA).

3. How accurate is the new test?

In clinical trials involving 8,714 specimens at 11 test sites, the HIV-1 test was shown to have a sensitivity of 99.9 percent and a specificity of 99.6 percent. Sensitivity means it is sensitive to the presence of HIV-1 99.9 percent of the time, and specificity means it is specific to HIV-1 antibodies, as opposed to other antibodies, 99.6 percent of the time. These figures are comparable to those for other currently approved HIV-1 test kits used by clinical laboratories.

4. How can a health professional get these test kits?

Murex Corporation of Toronto, the developer of this HIV-1 antibody test kit, will market the newly licensed diagnostic test kit under the trade name Murex SUDS HIV-1 Test.

5. Who can I contact for more information on tests for HIV infection and AIDS?

The CDC National AIDS Hotline (1-800-342-AIDS) has trained information specialists to answer questions or provide referrals on HIV infection and AIDS.

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