Illumina DNA Prep with Enrichment Dx

Illumina DNA Prep with Enrichment Dx

A library preparation and enrichment solution for in vitro diagnostic (IVD) targeted sequencing applications.

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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

Intended use (CE-marked IVD) 

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.

Intended use (FDA-registered) 

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.

Specifications

Assay time ~7 hours
Hands-on time ~1 hr
Input quantity 50-1000 ng genomic DNA derived from human cells and tissue including whole blood or FFPE tissue
Instruments NovaSeq 6000Dx Instrument, MiSeqDx Instrument, NextSeq 550Dx Instrument
Method Target Enrichment, Exome Sequencing, Custom Sequencing, Targeted DNA Sequencing
Nucleic acid type DNA
Species category Human
Technology Sequencing

Required products

To prepare targeted NGS libraries, Illumina DNA Prep with Enrichment Dx requires a user-supplied compatible enrichment panel and Local Run Manager. Speak with an Illumina sales representative to arrange installation on your Dx instrument. 

Instrument-specific reagent kits are also required: MiSeqDx Reagent Kit v3 (Catalog no. 20037124), NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) (Catalog no. 20028871), or NovaSeq 6000Dx Reagent Kit v1.5 (300 Cycles) (Catalog no. 20046931 or 20046933).  

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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

1
Prep

Illumina DNA Prep with Enrichment Dx 

2
Sequence
3
Analyze

DRAGEN for Illumina DNA Prep with Enrichment Dx App**

*Local Run Manager in Dx mode offers onboard primary analysis on the MiSeqDx or NextSeq 550Dx instruments.

**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.

Documentation

Product literature
Support documentation

Figures

Assay performance with whole-exome panelsa

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

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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.

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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.

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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.

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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.

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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.

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FAQs

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. 

You will need to order the Dx reagents designated for your Illumina Dx sequencing Instrument: 

Not all reagent kits will be available in all countries. Please visit each product page to learn more. 

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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NextSeq 550Dx Reagents

These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing on the NextSeq550 Dx Instrument.

VeriSeq NIPT Solution v2

Comprehensive in-lab NIPT IVD solution including reagents, instruments, and software for accurate aneuploidy screening results in 26 hours.

TruSeq Custom Amplicon Kit Dx

A validated, FDA-regulated kit enabling clinical laboratories to design their own next-generation sequencing assays for use on the MiSeqDx and NextSeq 550Dx systems.

MiSeqDx Reagent Kit v3

A validated, FDA-regulated, CE-marked IVD sequencing reagent kit, offering improved quality scores compared to previous versions.

TruSight Cystic Fibrosis

FDA-regulated, CE-marked in vitro diagnostic (IVD) next-generation sequencing assay conveniently providing two cystic fibrosis tests in one product.

NextSeq 550Dx Reagents

These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing on the NextSeq550 Dx Instrument.

NovaSeq 6000Dx Reagent Kits

These sequencing reagent kits allow clinical laboratories to perform high-throughput in vitro diagnostic testing on the NovaSeq 6000Dx instrument.

Speak with a specialist

Have additional questions about Illumina DNA Prep with Enrichment Dx? Contact us today.