Includes one MiSeqDx Instrument with embedded touch screen monitor and on-instrument computer, dual surface imaging capability, MiSeq Software Suite, installation kits, installation and training, and 12 months warranty (including parts and labor) to support automated generation of DNA clonal clusters by bridge amplification, sequencing, and primary and secondary analysis. Qualification services, instrument service plans, and reagent kits sold separately.
Available in > 45 countries, the MiSeqDx is an in vitro diagnostic (IVD) next-generation sequencing instrument for diagnostics and clinical research.
Tailored to the diverse needs of clinical labs
System specifications
Output range
≥ 5 Gb
Paired-end reads per run
≥ 15M
Max read length
2 × 150 bp
Results based on MiSeqDx Reagent Kit v3.
Simple, comprehensive solution for clinical laboratory environments
From library prep to informatics, the MiSeqDx Instrument provides easy-to-follow workflows and integrated software that deliver accurate, reliable screening and diagnostic testing.
Manage workflow
Manage your workflow seamlessly with Clarity LIMS or your existing LIMS system.
Prepare libraries
Choose from a menu of FDA-cleared assays available exclusively on the MiSeqDx Instrument.
Sequence
Produce sequences with ready-to-use reagents featuring proven Illumina sequencing by synthesis chemistry.
Analyze data
Analyze data automatically at the completion of a run with Local Run Manager.
Interpret results
Generate detailed reports using TruSight Software Suite.
One instrument. Many applications.
With the flexibility to operate in either Research Use Only (RUO) or Dx Mode, the MiSeqDx Instrument can conduct clinical research, develop, and run a range of IVD assays on the same instrument.
Intended Use for the MiSeqDx Instrument
United States:
The MiSeqDx Instrument is intended for targeted sequencing of DNA libraries from human genomic DNA extracted from peripheral whole blood, formalin-fixed, paraffin-embedded (FFPE) tissue, or embryonic tissue, when used with in vitro diagnostic (IVD) assays performed on the instrument. The MiSeqDx Instrument is not intended for whole genome or de novo sequencing. The MiSeqDx Instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software.
European Union/other:
The MiSeqDx 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 with in vitro diagnostic (IVD) assays performed on the instrument. The MiSeqDx Instrument is not intended for whole genome or de novo sequencing. The MiSeqDx Instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software.
Specifications
Output per flow cell for various read lengths
Read length
MiSeqDx Reagent Kit v3
2 x 150 bp
≥ 5 Gb
Estimated sample throughput for key applications
Sample type
MiSeqDx Reagent Kit v3
Human peripheral whole blood for cystic fibrosis testing
24-96 samples per run
Reads passing filter per flow cell
Sample type
MiSeqDx Reagent Kit v3
Paired-end reads
≥ 15M
Quality scores
Read length
MiSeqDx Reagent Kit v3
2 x 150 bp
≥ 80% of bases higher than Q30
Run time
Read length
MiSeqDx Reagent Kit v3
2 x 150 bp
24 hr
Total overall accuracy
Variant calling
Accuracy
Germline
> 99.9% overall percent agreement to reference results
Somatic
100% overall percent agreement to reference result
Total overall reproducibility
Variant calling
Accuracy
Germline
99.88% overall percent agreement to reference results
