• Print
  •  

ViroSeq® HIV-1 Genotyping System

For In Vitro Diagnostic Use
View Ordering Information
Product Name Quantity Order # Additional Information

ViroSeq HIV-1 Genotyping System v2.0 Kit, IVD

  • Sample Preparation Module
  • RT-PCR Module
  • Sequencing Module
  • 8E5 Control Module
 48 Tests/Kit 4J94-91 Order
Sequencing Consumables Pack 96 Tests/Kit 4J94-92 Order
PCR Cleanup Reagent 96 Tests/Kit 4J94-73 Order

Intended Use 

The ViroSeq HIV-1 Genotyping System is intended for use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. Specifically, the ViroSeq HIV-1 Genotyping System can be used to:

  • Detect HIV-1 Subtype B viral resistance in plasma samples collected in EDTA with a viral load ranging from 2000 to 750,000 copies/mL
  • Genotype the entire HIV-1 protease gene from codons 1-99 and two-thirds of the reverse transcriptase (RT) gene from codons 1-335

Indication for Use
The indications for use encompass the following populations:

  • HIV-1 infected individuals at drug therapy failure (with increased viral load) before therapy switch
  • HIV-1 infected individuals at initial presentation, before initial drug therapy

Completely Integrated

  • High throughput processing with automated sequencing
  • Integrated system including sample preparation, RT-PCR, cycle sequencing module, and positive controls
  • Autoloading of samples provides walkaway processing

Completely Targeted

  • Software converts continuous sequenced data for entire protease and 1 to 335 codons in reverse transcriptase to patient report
  • Comprehensive drug resistance interpretation algorithm.
  • Software provides interpretive resistance report to aid in treatment decisions

Completely In - Depth

  • In depth understanding leads to targeted treatment decisions
  • Integrated system from sample prep to final report
  • Unattended hands-free capillary electrophoresis
  • Powerful analysis software provides comprehensive drug resistance reports to assist with treatment decisions

Complete Genomic Coverage

  • Seven sequencing reactions with forward and reverse orientations achieve full codon coverage
  • Redundant sequencing primers provide overlappping genomic coverage

Most Complete Genomic Coverage
Seven sequencing reactions with forward and reverse orientations achieve full codon coverage.  Redundant sequencing primers provide multiple genomic coverage.

ViroSeq HIV-1 Genotyping System


Time-Saving ViroSeq HIV-1 Genotyping
System Workflow*

 ViroSeq HIV-1 Genotyping System Workflow Integrated Sequencing system encompasses sample preparation, RT-PCR, automated sequencing, controls, analysis, and resistance reporting. 

*For processing 12 samples on the ABI Prism® 3100/3130 Genetic Analyzers

 

Intended Use

 

The ViroSeq HIV-1 Genotyping System is intended for use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. Specifically, the ViroSeq HIV-1 Genotyping System can be used to:

  • Detect HIV-1 Subtype B viral resistance in plasma samples collected in EDTA with a viral load ranging from 2,000 to 750,000 copies/mL
  • Genotype the entire HIV-1 protease gene from codons 1 to 99 and two-thirds of the reverse transcriptase (RT) gene from codons 1 to 335

In order to use the ViroSeq HIV-1 Genotyping System

  • The user (operator or technologist) must be trained in its use
  • Interpretation and application of the results should be done by a qualified physician

The kit is not to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.

 

Limitations

  1. Blood collected using Heparin tubes is unsuitable for use with PCR and this assay.
  2. Testing for antiretroviral drug resistance has only been validated on patient samples with viral loads between 2,000 and 750,000 copies per mL. In a typical HIV positive patient population in the U.S. that is on HIV highly active antiretroviral therapy (HAART), about 25% of the patients can be expected to have suppressed viral loads. These samples may not always generate interpretable results with the ViroSeq HIV-1 Genotyping System if the viral load is below 1,000 copies/mL. Users should test samples with a viral load of 2,000 copies/mL or greater.
  3. In accordance with the FDA Guidance document for HIV-1 genotyping, analytical studies using the ViroSeq HIV-1 Genotyping System have not been completed at the limit of detection for the following mutations:
  • Gene RT
    Mutation E44D, K65N, D67E/G, D67N, T69N, K70E, L74I, V75A/I/M/S/T, A98G, L100I, K101E/P/Q, K103H/S/T/R, V106M, V108I, Y115F, E138K, Q151L, V179D/E/F, Y181I/V, Y188H, G190A/C/E/Q/S/T/V, T215C/D/E/I/S/V, K219N/R, P225H, F227L/C, M230L, P236L, K238T, Y318F
  • Gene Protease
    Mutation L10F/V, V11I, L23I, L24I, V32I, L33F, E35G, K43T, M46L/V, I47A/V, I50L, F53L, I54A/L/M/S/T, Q58E, A71I/T, G73A/C/S/T, T74P, L76V, V82L, N83D, I84A/C, N88D/S/T, L89V

Caution

United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician.

For In Vitro Diagnostic Use