Ordering Recommendation

Provides antiretroviral susceptibility information for protease inhibitors (PI), reverse transcriptase inhibitors (NRTI, NNRTI), and integrase inhibitors (INT). Intended for patients with viral load >500 copies/mL.

Mnemonic

HIV1 NGS

Methodology

Massively Parallel Sequencing

Performed

Sunday-Saturday

Reported

4-10 days

New York DOH Approval Status

Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.

Specimen Required

Patient Preparation
Collect

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

Specimen Preparation

Separate plasma from cells within 24 hours. Transfer 2.5 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

After separation from cells: Ambient: 24 hours; Refrigerated: 72 hours; Frozen: 3 months

Reference Interval

By report

Interpretive Data

This assay predicts HIV-1 resistance to protease inhibitors, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and integrase inhibitors. The protease gene, integrase gene and the reverse transcriptase gene of the viral genome are sequenced using Next Generation Sequencing. Drug resistance is assigned using the Stanford hivdb database.

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 adherence, percentage of resistant virus population, dosing, and drug pharmacology issues.

This test detects populations down to 10 percent of the total population which may account for resistance interpretation differences between methods. Some insertions or deletions may be difficult to detect using this software.

This test was developed, and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Note

This test may be unsuccessful if the plasma HIV-1 RNA viral load is less than 500 copies per mL of plasma.

Hotline History

N/A

CPT Codes

87900; 87901; 87906

Components

Component Test Code* Component Chart Name LOINC
3003854 HIV-1 Drug Resistance by NGS 80689-3
3003855 EER HIV-1 Drug Resistance by NGS 11502-2
* 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
  • HIV Integrase
  • 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 Drug Resistance by Next Generation Sequencing