HIV-1 Coreceptor Tropism, Ultradeep Sequencing

Test Code

94014

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

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: 4-11 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

Performing Laboratory

Quest Diagnostics Nichols Institute-San Juan Capistrano, CA

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.