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    Datasheet Miseqdx Instrument

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    Gopal Gopinath
    The document describes the MiSeqDx instrument, the first next-generation sequencing system cleared by the FDA for in vitro diagnostic use. It has an easy-to-use touchscreen interface and automated workflow. The instrument uses proven Illumina sequencing technology and is designed for clinical applications and custom diagnostic kit development. It allows simple sample preparation and fast, accurate variant detection compared to Sanger sequencing.

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    Datasheet Miseqdx Instrument

    Uploaded by

    Gopal Gopinath
    138 views4 pages
    The document describes the MiSeqDx instrument, the first next-generation sequencing system cleared by the FDA for in vitro diagnostic use. It has an easy-to-use touchscreen interface and automated workflow. The instrument uses proven Illumina sequencing technology and is designed for clinical applications and custom diagnostic kit development. It allows simple sample preparation and fast, accurate variant detection compared to Sanger sequencing.

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    information on miseq machine

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    The document describes the MiSeqDx instrument, the first next-generation sequencing system cleared by the FDA for in vitro diagnostic use. It has an easy-to-use touchscreen interface and automated workflow. The instrument uses proven Illumina sequencing technology and is designed for clinical applications and custom diagnostic kit development. It allows simple sample preparation and fast, accurate variant detection compared to Sanger sequencing.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    138 views4 pages

    Datasheet Miseqdx Instrument

    Uploaded by

    Gopal Gopinath
    The document describes the MiSeqDx instrument, the first next-generation sequencing system cleared by the FDA for in vitro diagnostic use. It has an easy-to-use touchscreen interface and automated workflow. The instrument uses proven Illumina sequencing technology and is designed for clinical applications and custom diagnostic kit development. It allows simple sample preparation and fast, accurate variant detection compared to Sanger sequencing.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    The key takeaways are that the MiSeqDx instrument is the first FDA-cleared NGS system for clinical use, it offers a simple workflow and user-friendly interface, and it uses Illumina sequencing by synthesis technology.

    The MiSeqDx instrument has an easy-to-use touchscreen interface, uses proven Illumina sequencing technology, has a wide range of applications including custom diagnostic kit development, and offers research capabilities. It also has a small footprint and integrated software for sample tracking and results interpretation.

    The MiSeqDx instrument uses Illumina sequencing by synthesis (SBS) chemistry, which involves massively parallel sequencing of millions of DNA fragments using a reversible terminator-based method to detect single bases as they are incorporated into growing DNA strands.

    Data Sheet: Molecular Diagnostics

    MiSeqDx Instrument
    The first FDA-cleared next-generation sequencing system for in vitro diagnostic use.
    Highlights
    Easy-to-Use Instrument
    Intuitive touch screen interface combined with an
    automated workflow makes for simple instrument
    operation
    Industry-Leading Illumina Sequencing
    Technology
    Widely adopted technology in the sequencing
    community as proven by the number of
    publications in the PubMed database
    Wide Range of Applications
    Designed for the development of custom in vitro
    diagnostic (IVD) kits and assays

    Figure 1: MiSeqDx Instrument. The FDA-cleared MiSeqDx


    instrument offers a simple workflow, a user-friendly software interface,
    and enhanced user security.

    Research Capabilities
    Use with Illumina library preparation assays when
    run in research mode

    (CF-specific) required by Sanger sequencing with a


    single reaction, saving time and reducing hands-on
    efforts for a more efficient workflow. The Illumina NGS
    technology reliably detects indels in homopolymeric
    regions, a challenge that is problematic to other
    sequencing systems. Results are comprehensive and
    obtained faster, eliminating the need for time-consuming
    additional testing.

    Overview
    The MiSeqDx instrument is the first FDA-cleared in vitro
    diagnostic (IVD) next-generation sequencing (NGS)
    system (Figure1). Designed specifically for the clinical
    laboratory environment, the MiSeqDx instrument offers
    a small, approximately 4squarefeet (0.3squaremeters)
    footprint, an easy to follow workflow, and data output
    tailored to the needs of clinical labs. In addition, the
    integrated software enables sample tracking, user
    traceability, and results interpretation*. Taking advantage
    of proven Illumina sequencing by synthesis (SBS)
    chemistry, the MiSeqDx instrument provides accurate,
    reliable screening and diagnostic testing.

    The NGS Advantage


    Compared to capillary electrophoresisbased Sanger
    sequencing, NGS offers more rapid and straightforward
    sample preparation methods. Illumina NGS on the
    MiSeqDx system replaces the multiple PCR steps
    * Detailed results reports are available for target-specific assays, such as the

    MiSeqDx Cystic Fibrosis 139-Variant Assay and the MiSeqDx Cystic Fibrosis
    Clinical Sequencing Assay.

    Simple, Three-Step Workflow


    Assays run in the MiSeqDx instrument follow a simple,
    three-step process (Figure 2) that starts with genomic
    DNA (gDNA) extracted from human peripheral whole
    blood specimens. gDNA samples are then prepared for
    sequencing through the addition of primers, generating
    indexed libraries for simultaneous capture and
    amplification of hundreds of targeted regions in multiple
    samples.
    Prepared libraries are sequenced using a ready-touse prefilled MiSeqDx reagent cartridge containing
    sequencing reagents. Simply thaw the cartridge, load
    the library, insert into the MiSeqDx instrument, and start
    sequencing with the push of a single button.

    Data Sheet: Molecular Diagnostics

    Prepare

    Sequence

    Start with genomic DNA

    Start the MiSeqDx instrument

    Create sample sheets

    Add the library to the


    pre-aliquoted, ready-to-use
    MiSeqDx reagent cartridge

    Generate indexed libraries

    Analyze
    See results in the MiSeq
    Reporter Software
    Interpret results

    Load into MiSeqDx and press GO

    Figure 2: Three-Step MiSeqDx Assay Workflow. Three basic steps for running an assay on the MiSeqDx instrument. Detailed results reports
    are only available with target-specific assays, such as the MiSeqDx Cystic Fibrosis 139-Variant Assay and the MiSeqDx Cystic Fibrosis Clinical
    Sequencing Assay.

    NGS on the MiSeqDx platform uses Illumina SBS


    chemistry in which massively parallel sequencing of
    millions of DNA fragments occurs by a proprietary
    reversible terminatorbased method. Single bases
    are detected as they are incorporated into growing
    DNA strands. Base calls are made directly from signal
    intensity measurements during each cycle. To learn
    more about SBS chemistry, visit www.illumina.com.

    Integrated System Software


    The MiSeqDx platform is the first IVD NGS instrument
    to offer a fully integrated sequencing ecosystem.
    Instrument software is accessed through a user-friendly
    touch screen interface. The Illumina Worklist Manager
    (IWM) software guides you through creation and setup
    of your sample sheet. MiSeq Operating Software (MOS)
    guides you through loading the sequencing cartridge
    (provided pre-loaded with reagents) and provides an
    overview of quality statistics for monitoring run progress.
    During the run, MOS also controls the flow cell stage,
    fluidics system, flow cell temperatures, and captures
    images of clusters on the flow cell. Upon completion
    of base calling, the MiSeq Reporter software analyzes
    assay data and generates the results report*.

    User Management Software


    To ensure proper system use, the MiSeqDx instrument is
    equipped with Illumina User Management Software and
    MiSeq Operating Software. Illumina User Management
    Software enables laboratories to control and trace
    system access, ensuring that only authorized personnel
    are running tests.

    Available Kits and Assays


    Two IVD assays and one IVD kit are currently available
    for use on the MiSeqDx instrument*:
    The MiSeqDx Universal Kit is an amplicon-based
    sequencing solution that enables users to develop
    assays targeting the genetic variants most important
    to them. Users design their own oligonucleotide
    probes specific to their regions of interest and use
    the validated reagents in the Universal Kit to prepare
    libraries and sequence.
    The MiSeqDx Cystic Fibrosis 139-Variant Assay
    detects 139clinically relevant and functionally verified
    variants as defined by the CFTR2 database1.
    The MiSeqDx Cystic Fibrosis Clinical Sequencing
    Assay detects mutations within the protein coding
    regions and intron/exon boundaries of the cystic
    fibrosis transmembrane conductance regulator
    (CFTR) gene.
    For added functionality, use Illumina library preparation
    assays designed for use on the MiSeq system on the
    MiSeqDx instrument when run in research mode.

    Learn More
    Learn more about the MiSeqDx instrument at
    www.illumina.com/miseqdx.

    Reference
    1. www.cftr2.org

    Data Sheet: Molecular Diagnostics

    MiSeqDx Instrument Specifications


    Instrument Configuration
    RFID tracking for consumables
    MiSeq Operating Software
    MiSeq Reporter Software
    Instrument Control Computer (Internal)
    Base Unit: Intel Core i7-2710QE 2.10 GHz CPU
    Memory: 16 GB RAM
    Hard Drive: 750 GB
    Operating System: Windows 7 embedded standard

    Intended Use
    The Illumina MiSeqDx is a sequencing instrument that measures
    fluorescence signals of labeled nucleotides through the use of
    instrument-specific reagents and flow cells (MiSeqDx Universal
    Kit1.0), imaging hardware, and data analysis software. The MiSeqDx
    platform is intended for targeted sequencing of human genomic DNA
    from peripheral whole blood samples. The MISeqDx platform is not
    intended for whole-genome or de novo sequencing. The MiSeqDx
    Instrument is intended to be used with Illumina-supplied IVD assays
    and reagent kits.

    Light Emitting Diode (LED)


    530 nm, 660 nm
    Dimensions
    WDH: 68.6 cm 56.5 cm 52.3 cm (27.0 in 22.2 in 20.6 in)
    Weight: 54.5 kg (120 lbs)
    Crated Weight: 90.9 kg (200 lbs)
    Power Requirements
    100240V AC @ 50/60Hz, 10A, 400W
    Radio Frequency Identifier (RFID)
    Frequency: 13.56 MHz
    Power: 100 mW
    Throughput
    848 samples/run, depending upon assay
    Performance Parameters
    Read Length: 2 150 bp
    Output: > 1 Gb
    Total overall accuracy: 99.66%a
    Total overall reproducibility: 99.70%a
    Bases with Q30 > 75%
    a

    Cystic fibrosis assay-dependent.

    Ordering Information
    Product

    Catalog No.

    MiSeqDx Instrument

    DX-410-1001

    MiSeqDx Universal Kit

    DX-103-1001

    MiSeqDx Cystic Fibrosis 139-Variant Assay


    (20 runs, up to 960 tests)

    DX-102-1003

    MiSeqDx Cystic Fibrosis 139-Variant Assay


    (2 runs, up to 96 tests)

    DX-102-1004

    MiSeqDx Cystic Fibrosis Clinical Sequencing


    Assay (6 runs, up to 48 samples)

    DX-102-1001

    Data Sheet: Molecular Diagnostics

    Illumina 1.800.809.4566 toll-free (U.S.) +1.858.202.4566 tel [email protected] www.illumina.com


    For In Vitro Diagnostic Use. Contact an Illumina representative for regional availability.
    2013-2014 Illumina, Inc. All rights reserved.
    Illumina, MiSeqDx, and the pumpkin orange color are trademarks of Illumina, Inc. and/or its affiliate(s) in the U.S. and/or other
    countries. Pub. No. 670-2013-005 Current as of 16 October 2014

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