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HIV-1 Genotype
Test Code34949
CPT Codes
87900, 87901
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top) tube or PPT (white-top) tube
Minimum Volume
0.6 mL
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 leak-proof transport tube, then freeze prior to shipment. Follow manufacturer's instructions for collection tube handling.
CSF: Collect CSF using standard procedures. Transfer to a sterile, leak-proof container. Ship frozen.
CSF: Collect CSF using standard procedures. Transfer to a sterile, leak-proof container. Ship frozen.
Transport Temperature
Frozen
Specimen Stability
Room temperature: 24 hours
Refrigerated: 6 days
Frozen: 42 days
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 >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 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.
Setup Schedule
Set up: Daily; Report available: 4-9 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.
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.
