HIV-1 Coreceptor Tropism, Ultradeep Sequencing
Test Summary
The use of CCR5 antagonists in patients harboring CXCR4(X4) or dual-mixed (DM) viruses has proven to be ineffective and leads to the emergence of X4 viruses as the predominant species in DM patients. In clinical trials, X4 virus was found in 55% of patients failing maraviroc therapy vs. only 9% of patients who experienced treatment failure in the placebo arm. The use of CCR5 antagonists, therefore, requires screening for viral tropism to exclude patients harboring X4 or DM virus. Detection of X4 virus prior to the initiation of therapy has been associated with a reduced response to maraviroc.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top), or PPT potassium EDTA (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 leak-proof transport tube, then freeze prior to shipment. Follow manufacturer's instructions for collection tube handling.
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Frozen
Specimen Stability
- Room temperature: 24 hours
- Refrigerated: 5 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Gross hemolysis • Lipemia • Serum • Non-centrifuged PPT • Frozen PPT (in SITU) • Heparinized plasma
Order Code
HIVTRP
EPIC (Premier) Code
LAB5861
Includes
N/A
CPT Code
- 87906
Billing Code
- 671008
CPT Statement
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) • Ultradeep 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, Thursday; Report available: 4 - 11 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top), or PPT potassium EDTA (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 leak-proof transport tube, then freeze prior to shipment. Follow manufacturer's instructions for collection tube handling.
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Frozen
Specimen Stability
- Room temperature: 24 hours
- Refrigerated: 5 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Gross hemolysis • Lipemia • Serum • Non-centrifuged PPT • Frozen PPT (in SITU) • Heparinized plasma
Result Information
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) • Ultradeep Sequencing
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Thursday; Report available: 4 - 11 days