A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
HIV-1 Coreceptor Tropism, Ultradeep Sequencing
Test Code94014
CPT Codes
87906
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.
Transport Container
Transport tube
Transport Temperature
Frozen
Specimen Stability
Room temperature: 24 hours
Refrigerated: 5 days
Frozen: 30 days
Refrigerated: 5 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Lipemia • Serum • Non-centrifuged PPT • Frozen PPT (in SITU) • Heparinized plasma
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 Infectious Disease. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon, Thurs; Report available: 5-12 days
Reference Range
See Laboratory Report
Clinical Significance
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
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf
Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
33608 Ortega Highway |
San Juan Capistrano, CA 92675-2042 |