ViroSeq HIV-1 Genotyping System

For In Vitro Diagnostic Use

Description

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

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.

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

High Throughput Processing with Automated Sequencing

Integrated systems including sample preparation, RT-PCR, cycle sequencing module, and positive controls
Autoloading of samples provides walk away processing

Targeted Therapy, Now a Reality

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

In - Depth Understanding for 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

Design

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

Time-Saving ViroSeq HIV-1 Genotyping
System Workflow*

Integrated Sequencing system encompasses sample preparation, RT-PCR, automated sequencing, controls, analysis, and resistance reporting.

*For processing 24 samples on the ABI Prism® 3100 Genetic Analyzer

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Order Information

Product Name	Package Size	Vysis Order Number	Abbott Order Number
ViroSeq HIV-1 Genotyping System v2.0 Pack 1 Sample Preparation Module RT-PCR Module Sequencing Module 8E5 Control Module		04J94-08	04J94-08 4J94
ViroSeq HIV-1 Genotyping System v2.0 Pack 2 YM-100 Microconcentrators MicroAmp Optical 96-well Reaction Plate with covers MicroAmp Tubes with Caps		04J94-07	04J94-07 4J94

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 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.

Indications 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

Limitations

Blood collected using Heparin tubes is unsuitable for use with PCR and this assay.
Testing for antiretroviral drug resistance has only been validated on patient samples with viral loads between 2000 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 1000 copies/mL. Users should test samples with a viral load of 2000 copies/mL or greater.
In accordance with the draft 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 E44A/D, D67E/G, D67N, T69A/I/N/S, K70E, L74I, V75A/I/M/S/T, A98G, L100I, K101E/P/Q, K103H/S/T, V106M, V108I, Y115F, Q151L, V179D/E, Y181I/V, Y188H, G190A/C/E/Q/S/T/V, T215 (notF/Y), K219N/R, P225H, F227L, M230L, P236L, Y318F
- Gene Protease
  Mutation L10F/V, I13L/V, K20M, K20V, L23I, L24I, V32I, L33F/I, E35G, M36L/V, K43T, K45I/R, M46L/V, I47A/V, I50L, F53L, I54A/L/M/S/T, Q58E, I66F, H69K, A71I/T, G73A/C/S/T, T74P, V71I, V82L, N83D, I84A/C, N88D/S/T, T91S

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.