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

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




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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