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Test ID FHIG HIV-1 Integrase Genotype

Method Name

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Sequencing

Reporting Name

HIV-1 Integrase Genotype

Specimen Type

Plasma EDTA

Draw blood in a (lavender-top) EDTA tube(s). Spin down and send 2 mL plasma frozen in a plastic vial.

Specimen Minimum Volume

0.6 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma EDTA Frozen (preferred) 35 days
  Refrigerated  5 days
  Ambient  24 hours

Clinical Information

The emergence of integrase drug resistance mutations has been observed in vitro 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 virologic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.

Reference Values

Reference Range(s):      See Lab Report

 

Day(s) Performed

Monday, Friday

Report Available

4 - 8 days

Performing Laboratory

Focus Diagnositics, Inc.

Test Classification

This test was developed and its analytical performance characteristics have been determined by Focus Diagnostics. 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.

CPT Code Information

87906

NY State Approved

Yes