Answer

 

The limitations of this test are similar to the limitations of other HIV antibody tests, including:

  • False Positives - although none were found in the clinical trial, a statistical analysis of the data indicates that a very small number of people who are not infected with HIV-1 will have reactive test results. As the test is used in broad outreach settings it is expected that false positives may be seen and therefore reactive results should not be considered definitive until confirmatory testing has been completed.

  • False Negatives - a small number of people who are infected with HIV-1 will have negative test results.

  • Delayed detection of exposure -- this test will not detect HIV-1 infection in people who were exposed within about three months prior to taking the test (since it can take that long for detectable antibodies to HIV-1 to appear in the blood).

  • Follow-up testing - a reactive result is interpreted as preliminarily positive for HIV-1 infection. Individuals with reactive test results should have follow-up testing using another method to confirm the initial test result.

For these reasons, all individuals taking this test must receive counseling both before being tested and after receiving their test results.



Last revised: March 28, 2007