HIV-1 Integrase Genotype : 16868

Message
Please provide most recent viral load and date of viral load.


Test Code
HIVITG or 16868


Alias/See Also
Isentress (Raltegravir, MK-0518) Resistance, HIV-1 Integrase Strand Transfer Inhibitor, Raltegravir, Elvitegravir, HIV-1 Integrase Mutations, MK-0518


CPT Codes
87906

Instructions
Lavender (EDTA) tube.  Alternative specimen: CSF.


Transport Container
Freshly drawn specimens (whole blood) may be stored at 2° C to 25° C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation.  Transfer 2 mL (Min: 0.6 mL) plasma to a standard transport tube.

CSF: 2 mL; transport in sterile leak-proof container.


Transport Temperature
Refrigerated.


Specimen Stability
After separation from cells: Room temperature: 24 hours; Refrigerated: 6 days; Frozen: 42 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Serum, Whole blood greater than 24 hours old, Frozen whole blood.


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

Setup Schedule
Monday  - Saturday


Report Available
4-8 days  (From receipt at performing laboratory)


Limitations
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.


Reference Range
See Laboratory Report.


Clinical Significance
The emergence of integrase drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on raltegravir in clinical trials. Twenty three percent of patients receiving raltegravir in a clinical trial experienced virologic failure at 48 weeks and genotypic analysis detected raltegravir associated resistance mutations in 68% of viroligic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.


Performing Laboratory
Quest Diagnostics



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.