Description
Overview
The TruSeq Custom Amplicon Kit Dx is an FDA-regulated amplicon sequencing kit that enables clinical labs to develop their own next-generation sequencing (NGS) assays for use on the FDA-regulated MiSeqDx and NextSeq 550Dx instruments.
Flexible assay design – Developed to meet individual, customer-defined needs
Validated kit – Verified performance specifications when used with Illumina instruments and reagents
Fast, reproducible results – Consistent results between multiple operators and systems
Flexible Assay Design
With the TruSeq Custom Amplicon Kit Dx, molecular diagnostics labs develop assays using their own oligonucleotide probe designs. The kit is optimized for use with formalin-fixed, paraffin-embedded (FFPE) samples and whole blood. This flexibility enables labs to expand the number of applications they can provide to meet customer needs.
Validated Kit
The TruSeq Custom Amplicon Kit Dx is validated to ensure consistent performance between lots, enabling long-term assay use, and facilitating change management.
High Assay Reproducibility
As demonstrated by a precision study, data produced using the TruSeq Custom Amplicon Kit Dx are highly reproducible.* Together with the MiSeqDx or NextSeq 550Dx, the TruSeq Custom Amplicon Kit Dx offers the accuracy and reliability needed to bring NGS capabilities into the clinical laboratory.
*See supporting data below
TruSeq Custom Amplicon Kit Dx
The Illumina TruSeq Custom Amplicon Kit 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 (FFPE) tissue. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina's high-throughput DNA sequence analyzers.
TruSeq Custom Amplicon Dx – FFPE QC Kit
The Illumina TruSeq Custom Amplicon Dx – FFPE QC Kit is a set of reagents used to determine the amplification potential of genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) samples.
MiSeqDx Reagent Kit v3
The Illumina MiSeqDx Reagent Kit v3 is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The MiSeqDx Reagent Kit v3 is intended for use with the MiSeqDx instrument and analytical software.
MiSeqDx Instrument
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 for 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.
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)
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.
NextSeq 550Dx High-Output Reagent Kit v2 (300 cycles)
The Illumina NextSeq 550Dx High-Output Reagent Kit v2 (300 cycle) 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 (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.
Example workflow
IVD Assay Development
MiSeqDx System
NextSeq 550Dx instrument
Local Run Manager
Related applications and methods
Molecular Diagnostics | NGS applications and solutions
Illumina offers a growing menu of solutions enabling clinical laboratories to create and deploy NGS-based molecular diagnostic tests.
MiSeqDx Instrument applications
Powerful and compact benchtop sequencing system for development of in vitro diagnostic assays and clinical research.
NextSeq 550Dx Instrument applications
A wide range of diagnostic and clinical sequencing applications on one instrument, plus array scanning in research mode.
Streamlined Custom Assay Workflow
The TruSeq Custom Amplicon Kit Dx enables clinical laboratories to develop their own NGS assays for use on the MiSeqDx or NextSeq 550Dx instruments.
Library Preparation Chemistry
The TruSeq Custom Amplicon Kit Dx uses customer-designed probes to capture and sequence specific targets.
Detection Capability of TruSeq Custom Amplicon Kit Dx
Target specifications allow the potential for sequencing > 90% of the exons in RefSeq genes, depending upon assay design.
Parameter: Germline
Genomic Context
GC content: 19–78%
PolyA length: ≤ 8
PolyT length: ≤ 10
PolyG length: ≤ 7
PolyC length: ≤ 6
Dinucleotide repeat length: ≤ 11×
Trinucleotide repeat length: ≤ 5×
Variants
Single nucleotide polymorphisms: Yes
Insertion length: ≤ 24bp
Deletion length: ≤ 25bp
Sequencing runs performed with the MiSeqDx Reagent Kit v3.
* Up to 78% with NextSeq 550Dx instrument.
High Assay Reproducibility
To demonstrate the high reproducibility of data produced using the TruSeq Custom Amplicon Kit Dx, a within-laboratory precision study was performed with a representative assay. The study used multiple operators, instruments, and lots across eight runs.
Analysis: Metric
Germline: PPA
PPA: Insertion
PPA: Deletion
NPA: –
Somatic: PPA
Percentages represent the lowest value across runs. Abbreviations: PPA = positive percent agreement, NPA = negative percent agreement, SNV = single nucleotide variant.
TruSeq® Custom Amplicon Kit Dx
20005718
Includes reagents and consumables for preparing up to 96 libraries from DNA extracted from peripheral whole blood and formalin-fixed, paraffin-embedded (FFPE) tissue. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. Purchase index plate fixture kits separately. View less
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TruSeq® Custom Amplicon Dx – FFPE QC
20006259
Includes reagents for determining the amplification potential of up to 48 samples of genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE). The kit supports four uses with 12 samples per use. For use with the TruSeq Custom Amplicon Kit Dx or other library preparation kits. View less
TruSeq Index Plate Fixture Kit (2 fixtures)
FC-130-1005
Includes two TruSeq Index Plate Fixtures to support correctly arranging index primers for PCR amplification. View less
TruSeq Index Plate Fixture & Collar Kit (2 each)
FC-130-1007
Assists in correctly arranging index primers for PCR amplification step. Includes two (2) TruSeq Index Plate Fixtures and two (2) Plate Collars. View less
MiSeq Dx Reagent Kit v3
20037124
Includes one flow cell and one prefilled cartridge containing clustering and sequencing reagents to support one run of sample libraries on the MiSeqDx System. View less
NextSeq550Dx Reagent Kit v2(300 cyc) IVD
20019554
NextSeq 550Dx High Output Reagent Kit v2 (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. View less
NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD
20028871
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. View less
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