Human Immunodeficiency Virus 1 (HIV-1) GenoSure Archive® Plus Trofile® DNA

TEST: 552020
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CPT: Call 800-222-7566, ext 6-8400, for coding.
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Synonyms

  • Cell-associated Viral DNA
  • HIV-1 Genotype
  • Resistance Analysis

Expected Turnaround Time

16 - 22 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Information

Related Documents

For more information, please view the literature below.

Coreceptor Tropism Assays

GenoSure Archive®: Cell-associated Viral DNA Assay for HIV-1 Protease, Reverse Transcriptase, and Integrase Inhibitors

GenoSure Archive®: HIV-1 Next Generation DNA Sequencing Assay for Suppression Management

HIV Specimen Collection Guide

HIV-1 Lifecycle, Drugs, and Susceptibility Assays

    Specimen Requirements

    Specimen

    Whole blood, frozen

    Volume

    8 mL

    Container

    Lavender-top (EDTA) tube

    Collection

    Collect specimen in two lavender-top (EDTA) tubes. Do not centrifuge. Ship frozen. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

    Storage Instructions

    Freeze.

    Causes for Rejection

    Quantity not sufficient for analysis; heparinized plasma; nonfrozen specimen

    Test Details

    Use

    Detect resistance of HIV-1 to protease, reverse transcriptase, and integrase inhibitors (GenoSure Archive®) and detect HIV-1 coreceptor tropism (Trofile® DNA) in cell-associated viral DNA; determine eligibility for CCR5 antagonist therapy, such as maraviroc (Selzentry®).

    Limitations

    This procedure should be used for patients with documented HIV-1 infection and undetectable viral load or low level viremia.

    This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

    Methodology

    GenoSure Archive®: Polymerase chain reaction (PCR) amplification and next generation DNA sequencing

    Trofile® DNA: Polymerase chain reaction (PCR) amplification and viral culture.

    References

    Günthard HF, Aberg JA, Eron JJ, et al. Antiretroviral treatment of adult HIV infection: 2014 recommendations of the International Antiviral Society-USA Panel. JAMA. 2014 Jul 23-30; 312(4):410-425. 25038359
    Hurt C. Transmitted resistance to HIV integrase strand-transfer inhibitors: Right on schedule. Antivir Ther. 2011; 16(2):137-140. 21447861
    Panel on Antiretroviral Guidelines for Adults and Adolescents—A Working Group of the Office of AIDS Research Advisory Council (OARAC). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Washington, DC: Department of Health and Human Services; May 1, 2014.
    Whitcomb JM, Huang W, Fransen S, et al. Development and characterization of a novel single-cycle recombinant-virus assay to determine human immunodeficiency virus type 1 coreceptor tropism. Antimicrob Agents Chemother. 2007 Feb; 51(2):566-575. 17116663

    LOINC® Map

    Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
    552020 GS Archive(R)+Trofile(R) DNA 551791 PDF 80695-0
    552020 GS Archive(R)+Trofile(R) DNA 551792 HIV GenoSure Archive N/A
    552020 GS Archive(R)+Trofile(R) DNA 551793 HIV GenoSure Archive 80693-5
    552020 GS Archive(R)+Trofile(R) DNA 551794 HIV GenoSure Archive Interp 80694-3
    552020 GS Archive(R)+Trofile(R) DNA 550341 Trofile(R) DNA PDF 51969-4
    552020 GS Archive(R)+Trofile(R) DNA 550347 Tropotype: 80690-1
    552020 GS Archive(R)+Trofile(R) DNA 829671 Trofile(R) DNA 50790-5
    552020 GS Archive(R)+Trofile(R) DNA 829672 Trofile(R) DNA Interpretation 62364-5
    Reflex Table for HIV GenoSure Archive
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 551781 HIV GSArchive 551781 HIV GSArchive N/A
    Reflex Table for HIV GenoSure Archive
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 551782 HIV GSArchive Interp 551782 HIV GSArchive Interp N/A

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    The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf