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HIV-1 Integrase Genotype
Test Code16868
CPT Codes
87906
Includes
Raltegravir Resistance
Elvitegravir Resistance
Dolutegravir Resistance
Bictegravir Resistance
Cabotegravir Resistance
Elvitegravir Resistance
Dolutegravir Resistance
Bictegravir Resistance
Cabotegravir Resistance
Preferred Specimen
2 mL plasma collected in an EDTA (lavender-top) 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 greater than 24 hours old • Frozen whole blood
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) • Sequencing
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
A.M.
Clinical Significance
Incomplete virologic suppression allowing continued viral replication in the presence of drugs can result in the emergence of drug resistant virus leading to therapeutic failure. The emergence of integrase strand transfer inhibitor (INSTI) drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on INSTI containing regimens (Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services). This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.
