Human Immunodeficiency Virus 1 (HIV-1) GenoSure Archive® Plus Trofile® DNA
CPT:
Call 800-222-7566, ext 6-8400, for coding.
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.
GenoSure Archive®: HIV-1 Next Generation DNA Sequencing Assay for Suppression Management
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 | 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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CPT Statement/Profile Statement
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