Book

Guidelines and Recommendations

Has Technical update: Technical update on HIV-1/2 differentiation assays. 2016.

List of Abbreviations -- A. Executive Summary -- B. Introduction -- C. Audience -- D. Scope -- E. Background and Rationale: Laboratory markers of HIV infection and their detection by diagnostic tests; Need for updated recommendations for the laboratory diagnosis of HIV-1 and HIV-2 infection -- F. Process for Developing Updated Recommendations -- G. Literature Reviews and Key Questions -- H. Recommendations for Laboratory Testing for the Diagnosis of HIV Infection -- I. Alternative Testing Sequences When Tests in the Recommended Algorithm Cannot be Used -- J. Limitations of the Recommended Laboratory Testing Algorithm -- K. Limitations of the Evidence Supporting These Recommendations -- L. How These Updated Recommendations Differ From Previous Recommendations -- M. Additional Considerations -- N. Reporting Results of the Recommended Algorithm for the Laboratory Diagnosis of HIV: Reporting HIV test results to persons who ordered HIV testing; Reporting HIV test results to public health authorities -- O. Plans for Updating These Recommendations -- -- Appendix 1. Members of Working Group that Developed Updated Recommendations -- -- Appendix 2. Analytic Framework, Search Strategy, and Summary of Evidence -- A. Analytic Framework -- B. Strategy for Searching Published Literature and Conference Abstracts -- C. Quality of Evidence -- D. Summary of Evidence Supporting the Recommendations -- E. Tables of Evidence -- References.

This document updates recommendations for HIV testing by laboratories in the United States and offers approaches for reporting test results to persons ordering HIV tests and to public health authorities. The recommended algorithm is a sequence of tests used in combination to improve the accuracy of the laboratory diagnosis of HIV based on testing of serum or plasma specimens. In brief, testing begins with a combination immunoassay that detects HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen. All specimens reactive on this initial assay undergo supplemental testing with an immunoassay that differentiates HIV-1 from HIV-2 antibodies. Specimens that are reactive on the initial immunoassay and nonreactive or indeterminate on the antibody differentiation assay proceed to HIV-1 nucleic acid testing for resolution.

CDC and the Association of Public Health Laboratories (APHL) have issued these recommendations based on HIV tests approved by the Food and Drug Administration (FDA) as of December 2012 and scientific evidence, laboratory experience, and expert opinion collected from 2007 through December 2013. These recommendations do not include the rapid HIV-1/HIV-2 antigen/antibody combination test approved by the FDA in August 2013 (for which evidence of performance in the algorithm was insufficient) or HIV-2 nucleic acid tests, which lack FDA approval. Because none of the assays in the recommended algorithm are FDA-approved for use with oral fluid or dried blood spot specimens, these updated recommendations do not supersede previous recommendations for testing of dried blood spots or oral fluid for HIV-1 using the FDA-approved immunoassay and HIV-1 Western blot for these specimen types.

Suggested citation: Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. Available at http://stacks.cdc.gov/view/cdc/23447. Published June 27, 2014. Accessed [date].

Supersedes: CDC. Interpretation and use of the Western blot assay for serodiagnosis of human immunodeficiency virus type 1 infections. MMWR Morb Mortal Wkly Rep. 1989;38(S-7):1-7, and: O'Brien TR, George JR, Epstein JS, Holmberg SD, Schochetman G. Testing for antibodies to human immunodeficiency virus type 2 in the United States. MMWR Recomm Rep. 1992;41(RR-12):1-9, and: Association of Public Health Laboratories and Centers for Disease Control and Prevention. HIV laboratory testing algorithms : a status report. March 2010.