CLSI M53:2023

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.