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For hours, walk-ins and appointments.Human Immunodeficiency Virus 1 (HIV-1) GenoSure PRIme® Plus Trofile®
CPT:
Call client servces.
Test Includes
HIV-1 inhibitor resistance; HIV-1 coreceptor tropism detection
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 Documents
For more information, please view the literature below.
HIV-1 Lifecycle, Drugs, and Susceptibility Assays
Specimen Requirements
Specimen
Plasma, frozen
Volume
Four tubes, 5 mL each
Container
Lavender-top (EDTA) or plasma preparation tube (PPT™)
Collection
Collect specimen in four lavender-top (EDTA) or four PPT™ tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection. Transfer plasma to one or more screw-cap polypropylene transport tube(s) (not "pop-top" or "snap-cap"), and freeze. Ship specimen 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 for shipment or long-term storage.
Causes for Rejection
PPT™ not centrifuged; insufficient volume; heparinized plasma; nonfrozen specimens; specimens exposed to repeated freeze/thaw cycles; specimen received in "pop-top" or "snap-cap" tubes
Test Details
Use
Detect resistance of HIV-1 to protease, reverse transcriptase, and integrase inhibitors (GenoSure PRIme®) and detect HIV-1 coreceptor tropism (Trofile®); determine eligibility for CCR5 antagonist therapy, such as maraviroc (Selzentry®)
Limitations
Trofile® should be used for patients with documented HIV-1 infection and when viral load is ≥1000 copies/mL.
GenoSure PRIme® may not be successful when the HIV viral load is <500 copies/mL plasma. If there is insufficient virus to produce genotype results, HIV-1 RNA quantification will be performed to confirm viral load, and the procedure will be billed at the account's prevailing fee.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
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Trofile® should be used for patients with documented HIV-1 infection and when viral load is ≥1000 copies/mL. GenoSure PRIme® may not be successful when the HIV viral load is <500 copies/mL plasma. If there is insufficient virus to produce genotype results, HIV-1 RNA quantification will be performed to confirm viral load, and the procedure will be billed at the account's prevailing fee. <. |
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Trofile® should be used for patients with documented HIV-1 infection and when viral load is ≥1000 copies/mL. GenoSure PRIme® may not be successful when the HIV viral load is <500 copies/mL plasma. If there is insufficient virus to produce genotype results, HIV-1 RNA quantification will be performed to confirm viral load, and the procedure will be billed at the account's prevailing fee. 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 PRIme®: Polymerase chain reaction (PCR) amplification and DNA sequencing. Trofile®: Polymerase chain reaction (PCR) amplification and viral culture.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 552014 | GenoSure PRIme(R)+Trofile(R) | 552019 | 51969-4 | |||
| 552014 | GenoSure PRIme(R)+Trofile(R) | 552021 | HIV GenoSure PRIme(R) | 80689-3 | ||
| 552014 | GenoSure PRIme(R)+Trofile(R) | 552022 | HIV GenoSure PRIme(R) Interp | 62364-5 | ||
| 552014 | GenoSure PRIme(R)+Trofile(R) | 829632 | Trofile(R) PDF | 51969-4 | ||
| 552014 | GenoSure PRIme(R)+Trofile(R) | 829666 | Tropotype: | 50790-5 | ||
| 552014 | GenoSure PRIme(R)+Trofile(R) | 829633 | Trofile(R) | 57182-8 | ||
| 552014 | GenoSure PRIme(R)+Trofile(R) | 829634 | Trofile(R) Interpretation | 77202-0 | ||
| 552014 | GenoSure PRIme(R)+Trofile(R) | 829635 | Trofile(R) Methodology | 49549-9 | ||
| 552014 | GenoSure PRIme(R)+Trofile(R) | 829636 | Trofile(R) References | 75608-0 |
| Reflex Table for HIV GenoSure PRIme(R) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 550504 | Quant, RNA PCR | 550497 | HIV-1 RNA by PCR | copies/mL | 20447-9 |
| Reflex Table for HIV GenoSure PRIme(R) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 550504 | Quant, RNA PCR | 550498 | log10 HIV-1 RNA | log10copy/mL | 29541-0 |
| Reflex Table for HIV GenoSure PRIme(R) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 552024 | GenoSure PRIme(R) | 552024 | GenoSure PRIme(R) | 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