HIV-1 Integrase Genotype
Order Code:
INTGEN
Test Summary
Incomplete virologic suppression allowing continued viral replication in the presence of drugs can result in the emergence of drug resistant virus leading to therapeutic failure. The emergence of integrase strand transfer inhibitor (INSTI) drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on INSTI containing regimens (Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services). This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top) tube, or EDTA PPT (white-top) tube
Minimum Volume
0.6 mL
Instructions
Do not freeze whole blood or any samples stored in primary tube. 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. If shipping frozen, transfer plasma to a leakproof transport tube, then freeze prior to shipment. Follow manufacturer's instructions for collection tube handling.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Frozen
Specimen Stability
- Room temperature: 24 hours
- Refrigerated: 6 days
- Frozen: 42 days
Limitations
N/A
Other Acceptable Specimens
2 mL CSF collected in a sterile leak-proof container
Unacceptable Specimens
Plasma received frozen in the plasma preparation tube (PPT) • Serum • Whole blood greater than 24 hours old • Frozen whole blood • Hemolysis • Lipemia
Order Code
INTGEN
EPIC (Premier) Code
LAB5145
Includes
Raltegravir Resistance
Elvitegravir Resistance
Dolutegravir Resistance
Bictegravir Resistance
Cabotegravir Resistance
Elvitegravir Resistance
Dolutegravir Resistance
Bictegravir Resistance
Cabotegravir Resistance
CPT Code
- 87906
Billing Code
- 671013
CPT Statement
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) • Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. 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
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 4 - 8 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top) tube, or EDTA PPT (white-top) tube
Minimum Volume
0.6 mL
Instructions
Do not freeze whole blood or any samples stored in primary tube. 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. If shipping frozen, transfer plasma to a leakproof transport tube, then freeze prior to shipment. Follow manufacturer's instructions for collection tube handling.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Frozen
Specimen Stability
- Room temperature: 24 hours
- Refrigerated: 6 days
- Frozen: 42 days
Limitations
N/A
Other Acceptable Specimens
2 mL CSF collected in a sterile leak-proof container
Unacceptable Specimens
Plasma received frozen in the plasma preparation tube (PPT) • Serum • Whole blood greater than 24 hours old • Frozen whole blood • Hemolysis • Lipemia
Result Information
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) • Sequencing
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 4 - 8 days