Ordering Recommendation

HIV-1 genotyping provides antiretroviral susceptibility information for protease inhibitors (PI) and reverse transcriptase inhibitors (NRTI, NNRTI). Intended for patients with viral load >1,000 copies/mL.

Mnemonic
HIV1GENO
Methodology

Reverse Transcription Polymerase Chain Reaction/Sequencing

Performed

Sun-Sat

Reported

3-7 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA) or plasma preparation tube.

Specimen Preparation

Separate plasma from cells within 6 hours. Transfer 4 mL plasma to an ARUP Standard Transport Tube. (Min: 1.5 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Serum. Heparinized specimens.

Remarks

Please submit most recent viral load and test date, if available.

Stability

On Cells: Ambient: 6 hours; After separation from cells: Ambient: 24 hours; Refrigerated: 5 days; Frozen: 4 months

Reference Interval

By report

Interpretive Data

This test predicts HIV-1 resistance to protease and reverse transcriptase inhibitor anti-retroviral drugs. The protease gene and codons 1-335 of the reverse transcriptase gene of the viral genome are sequenced using the Viroseq HIV-1 Genotyping System kit. Drug resistance is assigned using ViroSeq software. The most current resistance algorithm and drug list is available by selecting the Drug Resistance Report.

This test should be used in conjunction with clinical presentation and other laboratory markers. A patient's response to therapy depends on multiple factors including patient compliance, percentage of resistant virus population, dosing, and drug pharmacology issues. Resistance interpretations may vary with test methodology.

Some insertions or deletions may be difficult to detect using this software. This test may not detect minor HIV-1 populations less than 20 percent of the total population.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

This test may be unsuccessful if the plasma HIV-1 RNA viral load is less than 1,000 HIV-1 RNA copies per mL of plasma.

Hotline History
N/A
CPT Codes

87901

Components
Component Test Code* Component Chart Name LOINC
0051722 HIV-1 Genotype by Sequencing 53798-5
2002141 EER HIV-1 Genotype by Sequencing 11526-1
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • HIV Drug Resistance
  • HIV Genotype
  • HIV1 Genotype
  • HIV1 Genotyping
  • HIV1 Protease and Reverse Transcriptase Genotype
  • HIV1 Protease and Reverse Transcriptase Genotyping
  • HIV1 Protease and Reverse Transcriptase Sequencing
  • HIV1 Protease Genotyping
  • HIV1 Reverse Transcriptase Genotyping
  • HIV1 Sequencing
Human Immunodeficiency Virus 1, Genotype by Sequencing