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.

This product is only available in select locations. Please select the location where you would like this product to be shipped to see availability.

Overview

NextSeq 550Dx Reagent Kits contain reagents and consumables for supporting high-throughput sequencing of libraries for in vitro diagnostic testing.

  • Optimized IVD solution for sequencing on the NextSeq 550Dx Instrument

  • Improved signal-to-noise ratio and robust base calling

  • Intuitive labeling and RFID-encoded reagents

Regulatory compliance

NextSeq 550Dx Reagents feature increased shelf-life, single-lot shipment, and advance change notification, and include a certificate of analysis for each shipment. The kits are developed under design control principles, manufactured under cGMP, and verified to ensure consistent assay performance.

  • FDA-registered Class I medical device
  • IVDR-compliant CE-marked medical device

Ready-to-use

Each kit provides all components needed for sequencing on the platform in three ready-to-use cartridges (reagent, flow cell, and buffer). The kit offers simplified cartridge loading with all required reagents already in the cartridge. Simply load user-prepared library pools directly into the NextSeq 550Dx reagent cartridge and the instrument will automatically perform all steps for template amplification and sequencing without user intervention.


Intended use

NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles)

The Illumina NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software.

NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles)

The Illumina NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software.

NextSeq 550Dx Instrument (United States)

The NextSeq 550Dx instrument is intended for targeted sequencing of DNA libraries from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue, when used for in vitro diagnostic (IVD) assays performed on the instrument. The NextSeq 550Dx instrument is not intended for whole genome or de novo sequencing. The NextSeq 550Dx instrument is to be used with registered and listed, cleared or approved, IVD reagents and analytical software.

NextSeq 550Dx Instrument (European Union/Other)

The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic (IVD) assays performed on the instrument. The NextSeq 550Dx instrument is to be used with specific registered, certified or approved IVD reagents and analytical software.

Illumina DNA Prep with Enrichment Dx kit (United States)

Illumina DNA Prep with Enrichment Dx is a set of reagents and consumables used to prepare sample libraries from DNA extracted from peripheral whole blood and formalin-fixed, paraffin-embedded 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.

Illumina DNA Prep with Enrichment Dx kit (CE-marked IVD)

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.

For In Vitro Diagnostic Use

Contact an Illumina representative for regional availability.


Specifications


Required products

Select the NextSeq 550Dx Reagent Kit that matches the number of cycles that supports your read length needs. Intended for use on the NextSeq 550Dx Instrument. 

 

Also requires use of a validated library preparation solution:

  • Illumina DNA Prep with Enrichment Dx kit (IDPE Dx)
  • TruSight Oncology Comprehensive (EU)
  • VeriSeq NIPT Solution v2
  • Other library preparation solution validated by users or third-parties

 

The optional DRAGEN On-Premise Server for NextSeq 550Dx provides sequencing run setup, FASTQ file, and germline and somatic secondary analysis for libraries generated by IDPE Dx.

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Applications

The NextSeq 550Dx Reagent Kit is used by clinical laboratories for in vitro diagnostic testing and assay development on the NextSeq 550Dx Instrument.

Example workflows

Flexibility to support content types and IVD assay development

2
Sequence
  • NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles)
  • NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles)
3
Analyze

Illumina Manager – IDPE Dx app

Oncology testing

Noninvasive prenatal testing (NIPT)

2
Sequence
  • NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles)

Related applications and methods

NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD

20028871

Includes one high output flow cell, one buffer cartridge, and one reagent cartridge containing clustering and sequencing reagents to support a 300-cycle run on the NextSeq 550Dx System. All products registered for In Vitro Diagnostic sequencing.

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NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD

20028870

Includes one high output flow cell, one buffer cartridge, and one reagent cartridge containing clustering and sequencing reagents to support a 75-cycle run on the NextSeq 550Dx System. All products registered for In Vitro Diagnostic sequencing.

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FAQs

Each kit includes three ready-to-use cartridges containing all the components needed for sequencing on the platform (reagent, flow cell, buffers).

TruSight Oncology Comprehensive (EU) and VeriSeq NIPT Solution v2 are validated for use with NextSeq 550Dx Reagents on the NextSeq 550Dx Instrument.

Illumina DNA Prep with Enrichment Dx can be used with user-supplied probe panels to generate DNA libraries, which can be sequenced in the diagnostic mode of the instrument using NextSeq 550Dx reagent kits. The onboard Local Run Manager Generate FASTQ Dx module provides sequencing run setup and FASTQ files. The optional DRAGEN server for NextSeq 550Dx provides sequencing run setup, FASTQ files, and germline and somatic secondary analysis.

NextSeq 550Dx High-Output Reagent Kit v2.5 (300 Cycles) specifications: read length: 2 × 150 bp; clusters passing filter (per flow cell): 400 million; max output: 120 Gb; run time: < 25 hr; data quality (Q30): > 75%.

NextSeq 550Dx High-Output Reagent Kit v2.5 (75 Cycles) specifications: read length: 1 × 75 bp; clusters passing filter (per flow cell): 400 million; max output: 30 Gb; run time: < 11 hr; data quality (Q30): > 80%.

Learn more

The NextSeq 550Dx Instrument is an FDA-regulated and CE-marked IVD high-throughput sequencing system that provides both diagnostic and research modes. The NextSeq 550 System is for research use only (RUO).  In vitro diagnostic (IVD) testing is only supported on the NextSeq 550Dx Instrument. NextSeq 550Dx reagent kits are compatible with both diagnostic and research mode on the Dx instrument but are not compatible with the RUO system.

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