HIV-1 Genotype [34949]

Message
For Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.


Test Code
HIV1GN


Alias/See Also
34949


CPT Codes
87900, 87901

Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top), or potassium PPT (white-top) tube


Minimum Volume
0.6 mL
(Please note: This volume does not allow for repeat testing)


Other Acceptable Specimens
2 mL CSF collected in a sterile leak-proof container


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.


Transport Temperature
Frozen


Specimen Stability
Room temperature: 24 hours
Refrigerated: 6 days
Frozen: 42 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Plasma received frozen in the plasma preparation tube (PPT) • Serum • Whole blood greater than 24 hours old • Frozen whole blood


Methodology
DNA Sequencing • Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Infectious Disease Diagnostics. 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.

Setup Schedule
Set up: Daily; Report available: 5-10 days


Limitations
An infection is often composed of a variety of strains of the virus. The test may identify only the predominant type of virus thus leaving the minority viruses to thrive once the predominant type is treated. Lack of resistance may not confer susceptibilities.


Reference Range
See Laboratory Report


Clinical Significance
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 identifies drug resistance-associated mutations in the HIV-1 protease and reverse transcriptase genes. It can be used to predict antiretroviral drug resistance before initiation of therapy and in patients experiencing virologic failure while on therapy.


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042



Last Updated: November 30, 2021


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.