Description
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.
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.
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
Illumina DNA Prep with Enrichment Dx kit
NextSeq 550Dx Instrument
NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles)
NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles)
Local Run Manager Generate FASTQ Dx module
Illumina Manager – IDPE Dx app
TruSight Oncology Comprehensive (EU) Kit
Local Run Manager - TruSight Oncology Comprehensive (EU) Analysis Module
VeriSeq NIPT Sample Prep Kit
VeriSeq NIPT Assay Software v2
Related applications and methods
Clinical
Advancements in our understanding of genetics have the potential to change the practice of medicine and enable genomics-based health care.
Molecular diagnostics
Illumina offers a growing menu of solutions enabling clinical laboratories to create and deploy NGS-based molecular diagnostic tests.
What does each NextSeq 550Dx Reagent Kit contain?
Each kit includes three ready-to-use cartridges containing all the components needed for sequencing on the platform (reagent, flow cell, buffers).
Which Illumina assays are validated for use with NextSeq 550Dx Reagents?
TruSight Oncology Comprehensive (EU) and VeriSeq NIPT Solution v2 are validated for use with NextSeq 550Dx Reagents on the NextSeq 550Dx Instrument.
What is the validated IVD workflow to develop my own assay?
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.
What is the maximum output for each reagent?
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: 90 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 .
How are the NextSeq 550Dx Instrument and the NextSeq 550 System different?
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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