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.
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.