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Suggested reporting language for the HIV laboratory diagnostic testing algorithm
  • Published Date:
    April 2017
  • Status:
    current
  • Language:
    English
Filetype[PDF-1.29 MB]


Details:
  • Corporate Authors:
    Association of Public Health Laboratories (U.S.). HIV/Viral Hepatitis Subcommittee.
  • Description:
    To maximize public health impact, accurate, timely diagnostic HIV testing should be combined with clear result reporting and expedited linkage to medical care and services for infected persons. Laboratory reports should state each test that was performed, the final assay result of each test, and the final algorithm interpretation for the specimen.

    Since the 2014 HIV Laboratory Testing Algorithm1 (Appendix A, Figure 1) was released, several HIV diagnostic tests have been FDA-approved.2 One such test is the Geenius™ HIV1/2 Supplemental Assay that produces results that were not generated by the previously available HIV-1/HIV-2 differentiation test, Multispot HIV-1/2. This document addresses the new final assay results that may be produced by the Geenius™ HIV1/2 Supplemental Assay and updates the corresponding final algorithm interpretation for laboratory reports. This document also serves as an overall update to the 2013 version, Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm.3 A second update is forthcoming to address changes introduced by the BioPlex 2200 HIV Ag-Ab assay. Information about the algorithm and definitions used throughout this document are addressed in Appendix A. Since the 2014 algorithm, several documents have been published that address the Geenius assay including an Informational Update from APHL,2 a Technical Update from CDC,4 and a Technical Bulletin by Bio-Rad.5 This document incorporates aspects of the information from each of these documents to serve as a cohesive reference. The reporting language presented here is suggested for laboratories to use when reporting to healthcare providers and surveillance programs, but adjustments may be needed to meet individual facility or jurisdiction requirements. Major deviations should be considered carefully because misinterpretation of HIV test results can have serious implications..

    This publication was 100% funded with federal funds from a federal program of $159,671. This publication was supported by Cooperative Agreement # NU60OE000103 funded by the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC or the Department of Health and Human Services.

    ID_2017Apr-HIV-Lab-Test-Suggested-Reporting-Language.pdf

  • Funding:
    Cooperative Agreement # NU60OE000103
  • Supporting Files:
    No Additional Files
  1. Personal Author:
    Corporate Author:
    Published:
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