Description
Overview
Illumina DNA Prep with Enrichment Dx enables clinical labs to add targeted sequencing enrichment panels to their diagnostic applications and is an approved IVD medical device in the United States, the European Union, the United Kingdom, and other international markets.
This FDA-registered and EU IVDR 2017/746–compliant library prep and enrichment kit enables clinical labs to add targeted sequencing enrichment panels to their diagnostic applications.
Essential component for building a targeted NGS IVD assay on Illumina Dx instruments
Flexible support for various sizes of fixed and custom panels, including exome panels
Compatibility with Illumina and third-party enrichment DNA probe panels
Streamlined workflow enables smooth transition to assay development and implementation
Optimized performance
The kit is compatible with FDA-registered and CE-marked IVD NGS platforms that use proven sequencing by synthesis (SBS) chemistry to deliver highly accurate diagnostic testing.
Integrated software
Local Run Manager in Dx mode offers onboard primary analysis with a user-friendly interface on the MiSeqDx or NextSeq 550Dx instruments. The DRAGEN for Illumina DNA Prep with Enrichment Dx App performs alignment and variant calling in DNA for somatic and germline mutations. This app automatically launches secondary analysis when paired with an On-Premise DRAGEN Server and the NextSeq 550Dx or NovaSeq 6000Dx instruments via Illumina Run Manager.
Intended use
Illumina DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from genomic DNA derived from human cells and tissue to develop in vitro diagnostic assays. User supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina sequencing systems. The Illumina DNA Prep with Enrichment Dx includes software for sequencing run setup, monitoring, and analysis.
Illumina DNA Prep with Enrichment Dx is a set of reagents and consumables used to prepare sample libraries from genomic DNA derived from human cells and tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina sequencing systems.
Applications
Illumina DNA Prep with Enrichment Dx is an approved and registered IVD library prep and enrichment solution for in vitro diagnostic applications on the MiSeqDx, NextSeq 550Dx, and NovaSeq 6000Dx Instruments.
Example workflow
Illumina DNA Prep with Enrichment Dx
MiSeqDx Instrument
NextSeq 550Dx Instrument
NovaSeq 6000Dx Instrument
DRAGEN for Illumina DNA Prep with Enrichment Dx App*
*Automatically launches when paired with an On-Premise DRAGEN Server and the NextSeq 550Dx or NovaSeq 6000Dx instruments via Illumina Run Manager.
Application notes
High-quality variant calling with the NovaSeq 6000Dx instrument
Access a validated workflow for highly accurate germline and somatic variant calling.
Related applications and methods
NextSeq 550Dx applications and methods
Explore the versatility of application workflows for developing IVD tests and a range of research methods on a single instrument.
MiSeqDx applications and methods
MiSeqDx applications include IVD approved and registered assays for cystic fibrosis testing and NGS-based assay development.
In vitro diagnostic (IVD) instruments
Explore IVD instruments designed for the clinical lab environment.
Assay performance with whole-exome panels a
a. Coriell Cell Line gDNA NA12878, with a known truth set for germline variant detection (Coriell platinum genome). Libraries were sequenced on the NextSeq 550Dx Instrument with FASTQ files generated from base calls using the GenerateFASTQ Dx Module in Local Run Manager; custom scripts in the DRAGEN platform v3.8.4 were used for analysis.
Resources
Introducing Illumina DNA Prep with Enrichment Dx
Illumina DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples)
20051354
CE-marked and FDA-regulated IVD reagents , including index set A and size selection beads, for library preparation of genomic DNA isolated from 16 FFPE tissue samples. Purchase MiSeqDx, NextSeq 550Dx, or NovaSeq 6000Dx sequencing reagents separately. View less
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Illumina DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples)
20051355
CE-marked and FDA-regulated IVD reagents , including index set B and size selection beads, for library preparation of genomic DNA isolated from 16 FFPE tissue samples. Purchase MiSeqDx, NextSeq 550Dx, or NovaSeq 6000Dx sequencing reagents separately. View less
Illumina DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples)
20051352
CE-marked and FDA-regulated IVD reagents , including index set A and size selection beads, for library preparation of genomic DNA isolated from 96 peripheral whole blood samples. Purchase MiSeqDx, NextSeq 550Dx, or NovaSeq 6000Dx sequencing reagents separately. View less
Illumina DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples)
20051353
CE-marked and FDA-regulated IVD reagents , including index set B and size selection beads, for library preparation of genomic DNA isolated from 96 peripheral whole blood samples. Purchase MiSeqDx, NextSeq 550Dx, or NovaSeq 6000Dx sequencing reagents separately. View less
DNA Prep Enrichment Dx-Customer Site
20076400
1.5-day, hands-on instructions at customer site to familiarize users with Illumina DNA Prep with Enrichment Dx library prep workflow. Course provides hands-on sample and library prep, enrichment, quality control, best practices, troubleshooting, and related Illumina-supported sequencing and data analysis tools for a maximum of four trainees. View less
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How does Illumina DNA Prep with Enrichment Dx work?
Illumina DNA Prep with Enrichment Dx uses innovative on-bead tagmentation , which uses bead-bound transposomes to mediate a uniform reaction that integrates DNA extraction, fragmentation, library prep, and library normalization. This provides a rapid library prep and enrichment solution when combined with a simplified hybridization step. The kit includes clean-up beads for library purification and sequencing indexes.
What reagents do I need to use with Illumina DNA Prep with Enrichment Dx?
You will need to order the Dx reagents designated for your Illumina Dx sequencing Instrument:
MiSeqDx Reagent Kit v3
NextSeq 550Dx Reagents
NovaSeq 6000Dx Reagent Kits
Not all reagent kits will be available in all countries. Please visit each product page to learn more.
What sample types are supported by Illumina DNA Prep with Enrichment Dx?
Illumina DNA Prep with Enrichment Dx supports a wide range of genomic DNA (gDNA) derived from cells and tissue. This includes gDNA extracted from whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue.
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