scope:

This guideline provides:

• An overview of the natural history and response to HIV infection

• An in-depth review of initial and supplemental tests used for diagnosing HIV infection

• Tests for monitoring and managing HIV type 1 (HIV-1) infections

• Recommendations for initiating an HIV QC program

This guideline also discusses special situations that commonly cause confusion in HIV testing, including:

• Diagnosis of acute and recent HIV infection

• Testing for HIV-1, group 1, non-B subtype, and HIV type 2 (HIV-2) infections

• Initial and supplemental testing during pregnancy, labor, and delivery

• Newborn testing

• HIV-1 seroconversion or incomplete antibody (Ab) response

• Recipients of HIV vaccines or chimeric antigen receptor T-cell (CAR-T) therapy

• Viral suppressors (elite controllers [ECs])

• Testing for pre- and postexposure prophylaxis

• Testing for CSF for HIV-associated central nervous system (CNS) disorders

• Self-collection and self-testing

Also included are:

• Diagnostic testing algorithms to assist clinicians and laboratorians in the stepwise use of HIV tests

• A framework for determining the need for additional testing

• Results interpretation

• Reporting criteria for commonly obtained test results

This guideline is intended for use in diagnosing HIV-1 and HIV-2 infections in both advanced diagnostic laboratories and point-of-care (POC) settings, including resource-limited environments. It does not:

• Discuss methods or strategies for screening the blood supply or organ or tissue donation.

• Provide recommendations for use outside the clinical setting.

• Cover issues for diagnosing HIV from nonhuman material, environmental surfaces, or postmortem samples.