A validated, FDA-regulated kit enabling clinical laboratories to design their own next-generation sequencing assays for use on the MiSeqDx and NextSeq 550Dx systems.
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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.
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.
The TruSeq Custom Amplicon Kit Dx is validated to ensure consistent performance between lots, enabling long-term assay use, and facilitating change management.
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
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.
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.
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.
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.
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.
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.
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.
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.
| Instruments | MiSeqDx Instrument, NextSeq 550Dx Instrument |
|---|---|
| Method | Amplicon Sequencing, Custom Sequencing |
| Species category | Human |
| Technology | Sequencing |
For the TruSeq Custom Amplicon Kit Dx, use one of the following plate fixture kits to assist in correctly arranging index primers for PCR amplification.
Illumina offers next-generation sequencing-based molecular diagnostic options for clinical laboratories.
NextSeq 550Dx Applications & Methods
Explore the versatility of application workflows for developing IVD tests and a range of research methods on a single instrument.
MiSeqDx Applications & Methods
MiSeqDx applications include FDA-cleared and FDA-approved assays for cystic fibrosis testing, colorectal cancer evaluation, and NGS-based assay development.
The TruSeq Custom Amplicon Kit Dx enables clinical laboratories to develop their own NGS assays for use on the MiSeqDx or NextSeq 550Dx instruments.
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 | Somatic |
|---|---|---|
| Genomic Context | ||
| GC content | 19–78% | 19–73%* |
| PolyA length | ≤ 8 | ≤ 8 |
| PolyT length | ≤ 10 | ≤ 10 |
| PolyG length | ≤ 7 | ≤ 6 |
| PolyC length | ≤ 6 | ≤ 6 |
| Dinucleotide repeat length | ≤ 11× | ≤ 4× |
| Trinucleotide repeat length | ≤ 5× | ≤ 5× |
| Variants | ||
| Single nucleotide polymorphisms | Yes | Yes, 5% limit of detection |
| Insertion length | ≤ 24bp | ≤ 24bp |
| Deletion length | ≤ 25bp | ≤ 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 | Variant Type | MiSeqDx (8 runs) | NextSeq 550Dx (9 runs) |
|---|---|---|---|---|
| Germline | PPA | SNV | 99.8% | > 99.9% |
| PPA | Insertion | 99.1% | 98.9% | |
| PPA | Deletion | 99.8% | 100% | |
| NPA | – | 100% | 100% | |
| Somatic | PPA | SNV | 100% | 99.9% |
| PPA | Insertion | 100% | 99.9% | |
| PPA | Deletion | 100% | 99.9% | |
| NPA | – | > 99.9% | > 99.9% |
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.
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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.
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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.
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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.
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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.
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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.
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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