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Suggested reporting language for the HIV laboratory diagnostic testing algorithm
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  • Corporate Authors:
    Association of Public Health Laboratories (U.S.). HIV/Viral Hepatitis Subcommittee. ; Centers for Disease Control and Prevention (U.S.). ;
  • Description:
    In March 2010, the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) proposed a new HIV Laboratory Diagnostic Testing Algorithm which was updated at the December 2012 HIV Diagnostics Conference. The algorithm is presented as one of the options in the Clinical Laboratory Standards Institute (CLSI) guideline document M53-A entitled “Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection” and the updated version is described in CDC’s “Draft Recommendations: Diagnostic Laboratory Testing for HIV Infection in the United States.” The revised algorithm recommends initial testing with a 4th generation HIV-1/2 antigen/antibody combination immunoassay (IA) which, if reactive, is followed by supplemental testing with an HIV-1/2 antibody differentiation assay. Specimens negative or indeterminate by the HIV-1/2 antibody differentiation assay undergo an HIV-1 nucleic acid test (NAT). This marks the first time since 1989 that Western blot was not included in the HIV testing algorithm.

    APHL’s HIV/Hepatitis Subcommittee developed this document through consensus to provide suggested reporting language and interpretation of test results for the HIV Laboratory Diagnostic Testing Algorithm. Members of this subcommittee include subject matter experts from state and local public health laboratories. The reporting language presented here is suggested and may need to be adapted to meet individual facility or jurisdiction requirements and modified over time as additional practical experience is gained with the revised algorithm.

    The HIV Laboratory Diagnostic Testing Algorithm offers several advantages over the conventional algorithm of HIV antibody screening followed by Western blot confirmation of repeatedly reactive results, including earlier detection of HIV infections and the ability to accurately classify HIV-1 and HIV-2 infections. For maximum benefit of the algorithm, delayed testing should be avoided. Batching of specimens should be minimized, especially when supplemental testing is conducted.

    This document was developed by APHL’s HIV/Viral Hepatitis Subcommittee with significant input from the following individuals: Berry Bennett, MPH Bernard Branson, MD Steven Ethridge, MT Celia Hagan, MPH Michele Owen, PhD Mike Pentella, PhD Monica Parker, PhD Barbara Werner, PhD Laura Wesolowski, PhD Kelly Wroblewski, MPH.

    Supporting document for: Centers for Disease Control and Prevention and Association of Public Health Laboratories. <a href=23447 target=”_blank">Laboratory testing for the diagnosis of HIV infection: updated recommendations</a>. Published June 27, 2014.

    This publication was supported by Cooperative Agreement # U60HM000803 from CDC. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC. The total amount of funding received for the HIV Program is $98,847.

  • Funding:
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