US HIV Tests
Recommendations and Guidelines
In this section we describe all FDA-approved diagnostic HIV tests for use in moderate and high complexity laboratories, and updated recommendations for testing serum or plasma specimens.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), tests are classified according to the complexity of the test. CLIA-waived tests are simple tests for which the likelihood of erroneous test results is negligible.
Two home testing kits (the OraQuick In-Home HIV Test and the Home Access HIV-1 Test System) are now available in your local drugstore.