Test Summary
This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. The emergence of integrase drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on Raltegravir in clinical trials. Twenty three percent of patients receiving Raltegravir in a clinical trial experience virologic failure at 48 weeks and genotypic analysis detected raltegravir associated resistance mutations in 68% of virologic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.
Aliases
Specimen Collection
Special Instructions
N/A
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
2.5 mL
Instructions
Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation and immediately transfer to a transport tube. Follow manufacturer's instructions for collection tube handling.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 6 days
- Frozen: 42 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube
Unacceptable Specimens
Samples received in primary collection tube • Gross hemolysis • Lipemia
Order Code
HV1INT
EPIC (Premier) Code
LAB5229
Includes
If HIV-1 viral load is >400 copies/mL, then HIV-1 Integrase will be performed at an additional charge (CPT Code(s): 87906).
CPT Code
Billing Code
CPT Statement
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics Infectious Disease. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
HIV-1 RNA, QN, PCR Not detected copies/mL
HIV-1 RNA, QN, PCR Not detected Log copies/Ml
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 3 - 5 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
3 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
2.5 mL
Instructions
Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation and immediately transfer to a transport tube. Follow manufacturer's instructions for collection tube handling.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 6 days
- Frozen: 42 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in: PPT potassium EDTA (white-top) tube
Unacceptable Specimens
Samples received in primary collection tube • Gross hemolysis • Lipemia
Billing
CPT Code
Billing Code
CPT Statement
Result Information
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Testing Laboratory
N/A
Reference Range
HIV-1 RNA, QN, PCR Not detected copies/mL
HIV-1 RNA, QN, PCR Not detected Log copies/Ml
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 3 - 5 days
