Illumina DNA Prep with Enrichment Dx

An EU IVDR 2017/746-compliant library preparation and enrichment solution for in vitro diagnostic (IVD) targeted sequencing applications. Read More...

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ILMN DNA Prep w Enrich Dx, 16 spl, Idx A

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Product Highlights

The Illumina DNA Prep with Enrichment Dx kit offers an IVDR compliant solution with proven performance across Illumina Dx sequencing platforms. This kit enables clinical laboratories to add targeted sequencing to their menu of diagnostic applications and offers:

  • A core component of the IVDR assay pathway for performing validated NGS tests
  • Flexible library prep allows for enrichment panels of choice
  • Optimized performance on Illumina CE-marked IVD sequencing platforms
  • Easy-to-implement workflow enables transition to IVDR compliance
Validated IVDR-Compliant Solution

Illumina DNA Prep with Enrichment Dx is compliant with European Union (EU) In Vitro Diagnostics Regulation (IVDR) 2017/746 and delivers validated performance when used with Illumina DX sequencing instruments and Dx reagents.

Flexible Support for Content Types

Illumina DNA Prep with Enrichment Dx supports probe panels supplied by the user that meet the required specifications including fixed and custom panels of varying sizes, including those designed for whole-exome sequencing (WES). The kit is compatible with Illumina and third-party enrichment DNA probe panels for increased flexibility.

Optimized Performance on Illumina IVD Platforms

Illumina DNA Prep with Enrichment Dx is compatible with the MiseqDx, NextSeq 550Dx instruments and Dx sequencing reagents. These FDA-regulated and Conformité Européene in vitro diagnostic (CE-marked IVD) platforms are designed specifically to bring the power of NGS to the clinical laboratory. We also recommend an option to work with our field scientists who can offer in-depth training and support to enable the transition to IVDR compliance, ensuring the highest standards in clinical testing.

Integrated Software

DNA Local Run Manager (LRM) in Dx mode offers a fully integrated onboard primary analysis option accessed through a user-friendly touch screen interface. Local Run Manager automatically starts primary data analysis after a sequencing run is completed.

Local Run Manager modules require control Software System Suite integration:

  • MiSeq Dx MOS v4.0 is integrated with LRM v3.1
  • NextSeq 550Dx NOS v1.5 is integrated with LRM v3.2

If your Dx instrument requires installation of LRM to enable IDPE Dx, please contact your local sales team to arrange installation.

Frequently Purchased Together

Frequently purchased together

Illumina DNA Prep with Enrichment Dx
Illumina DNA Prep with Enrichment Dx

An IVDR compliant solution with proven performance across Illumina Dx sequencing platforms

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NextSeq 550Dx
NextSeq 550Dx

FDA regulated and CE-in vitro diagnostic (IVD) marked, enabling clinical laboratories to perform a range of applications.

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MiSeqDx
MiSeqDx

The MiSeqDx instrument is the first FDA-cleared in vitro diagnostic (IVD) next-generation sequencing (NGS) system.

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Specifications

Intended Use

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.

Method-Specific Workflow Example

 

Supporting Data and Figures

Assay performance with whole-exome panels
Assay performance with whole-exome panels

Related Products

MiSeqDx Reagent Kit v3

A validated, FDA-regulated, CE-IVD–marked sequencing kit for use on the MiSeqDx instrument, offering improved quality scores compared to previous versions.


NextSeq 550Dx Reagents

These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing.