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Technical update on HIV-1/2 differentiation assays
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  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.) ; Association of Public Health Laboratories. ; National Center for HIV/AIDS, Viral Hepatitis, and TB Prevention (U.S.). Division of HIV/AIDS Prevention.
  • Description:
    Technical update to: Laboratory testing for the diagnosis of HIV infection : updated recommendations . June 27, 2014.

    In response to changes in the commercial availability of HIV-1/HIV-2 antibody differentiation assays approved by the U.S. Food and Drug Administration (FDA) for diagnostic use, the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) are writing to share information on the only available differentiation assay as well as interim solutions for HIV testing.

    The CDC and APHL continue to recommend that laboratories use a laboratory-based HIV antigen/antibody HIV screening immunoassay, followed, when reactive, by an HIV-1/HIV-2 antibody differentiation immunoassay. When the differentiation assay returns a negative or indeterminate result, perform an HIV-1 nucleic acid test (NAT).1 In addition to being accurate, HIV testing should be expedited to reduce the time to antiretroviral treatment because infected persons have better health outcomes when they are treated earlier and treatment of infected persons reduces transmission of HIV to others.


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