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TruSight Whole Genome检测支持临床实验室在其诊断应用的目录中添加WGS，并提供：
TruSight Whole Genome
符合欧盟IVDR 2017/746号法规要求且可扩展的全基因组测序解决方案，适用于临床诊断测试。
需要由因美纳代表在您的NovaSeq 6000Dx仪器上安装TruSight Whole Genome分析应用程序才能进行TruSight Whole Genome检测。在运行检测之前，请联系您的因美纳代表来安排此安装。
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概览
主要特点
TruSight Whole Genome为临床WGS提供了符合欧盟IVDR法规要求且全面的DNA到VCF工作流程解决方案。这种经过验证的解决方案消除了开发对照、构建生物信息学流程以及执行昂贵且耗时的分析验证研究的负担，促进了WGS在临床中的应用。
TruSight Whole Genome检测的分析验证依据临床与实验室标准协会（CLSI）指南进行，涉及450多个临床样本和150多次测序运行。检测开发过程中包含的QC指标和置信区域可识别性能较差的样本并过滤数据。这减少了假阳性和假阴性结果，并显著提高了性能。
预期用途
TruSight Whole Genome是一款定性体外诊断器械，用于全基因组测序和检测从血液中提取的人类基因组DNA中的单核苷酸变异、插入/缺失、拷贝数变异、连续性纯合片段、短串联重复扩增和线粒体变异。
TruSight Whole Genome包括带有唯一双标签的TruSight Whole Genome Dx Library Prep和TruSight Whole Genome分析应用软件。该诊断器械旨在与兼容的下游生殖系应用配合使用，并由合格的实验室人员和检测开发人员用于开发体外诊断检测。
TruSight Whole Genome适用于NovaSeq 6000Dx仪器。
规格
| Assay time | < 3 days |
|---|---|
| Input quantity | 280ng gDNA |
| 系统 | NovaSeq 6000Dx Instrument |
| 方法 | Whole-genome sequencing |
| 核酸类型 | DNA |
| Sample throughput | 6 samples per S2 Dx flow cell and 16 samples per S4 Dx flow cell |
| 物种 | 人 |
| 技术 | Illumina测序 |
需要的产品
TruSight Whole Genome requires a NovaSeq 6000Dx Reagent Kit and associated buffer cartridge and library tube.
· For a single NovaSeq 6000Dx S2 Reagent Kit v1.5 (300 cycles), 1 NovaSeq 6000Dx S2 Buffer Cartridge and 1 NovaSeq 6000Dx Library Tube is required.
· For a single NovaSeq 6000Dx S4 Reagent Kit v1.5 (300 cycles), 1 NovaSeq 6000Dx S4 Buffer Cartridge and 1 NovaSeq 6000Dx Library Tube is required.
The TruSight Whole Genome Analysis Application must be installed on the NovaSeq 6000Dx instrument in order to run TruSight Whole Genome. This installation must be performed by an Illumina Representative.
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结果
Applications
Example workflow
Library Preparation
TruSight Whole Genome Dx Library Prep
Sequencing
Data Analysis
TruSight Whole Genome Analysis Application via DRAGEN server with Illumina Run Manager*
* Must be installed by an Illumina Representative on the NovaSeq 6000Dx instrument
Figures
Built-in analytical QC metrics ensure performance
QC based on run and sample performance specifications, metrics, including coverage, uniformity, and base quality, fails poor performing samples to ensure optimal analytical performance without the need for external batch controls.
Filtering for variants of high and intermediate confidence improves performance
TruSight Whole Genome at a glance
TruSight Whole Genome variant calling performance
TruSight™ Whole Genome Dx Library Prep with UD Indexes, 24 sample
20093209
This is an In Vitro Diagnostic (IVD) next generation sequencing library prep that supports the TruSight Whole Genome assay workflow. This kit provides the necessary library prep reagents and indexes to support 24 samples and can only be used with the NovaSeq 6000Dx instrument. The NovaSeq 6000Dx core consumables are not provided in this kit and must be purchased separately. Required software for analysis must be installed by Illumina personnel.
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TruSight Whole Genome Customer Training – Customer Site
20122846
A 1.5-day onsite training for the complete TruSight Whole Genome Dx Library Preparation workflow, with detailed hands-on instruction. Participants will learn all steps of the workflow including sample and library preparation, quality control, best practices, and troubleshooting. Training on Illumina-supported sequencing and data analysis tools specific to the TruSight Whole Genome workflow will be included.
NovaSeq 6000Dx S2 Reagent Kit v1.5 (300 cycles) IVD
20046931
Includes one S2 flow cell (with four lanes), one cluster cartridge, and one sequencing by synthesis (SBS) cartridge to support one 300-cycle run on the NovaSeq 6000Dx. Requires separate purchase of one buffer cartridge and one library tube for each run. All products registered for In Vitro Diagnostic sequencing.
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NovaSeq 6000Dx S2 Buffer Cartridge
20062292
Includes one S2 buffer reagent cartridge to dilute denatured libraries prior to sequencing, required to support each S2 flow cell 300-cycle run.
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NovaSeq 6000Dx S4 Reagent Kit v1.5 (300 cycles) IVD
20046933
Includes one S4 flow cell (with four lanes), one cluster cartridge, and one sequencing by synthesis (SBS) cartridge to support one 300-cycle run on the NovaSeq 6000Dx. Requires separate purchase of one buffer cartridge and one library tube for each run. All products registered for In Vitro Diagnostic sequencing.
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NovaSeq 6000Dx S4 Buffer Cartridge
20062293
Includes one S4 buffer reagent cartridge to dilute denatured libraries prior to sequencing, required to support each S4 flow cell 300-cycle run.
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NovaSeq 6000Dx Library Tube, IVD
20062290
Includes one NovaSeq 6000Dx Library Tube, IVD, required for each S2 or S4 flow cell 300-cycle run.
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NovaSeq 6000Dx Library Tubes Accessory Pack (24 tubes) IVD
20062291
Includes 24 NovaSeq 6000Dx Library Tubes.
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MiSeq Reagent Kit v3
与早期版本相比，优化的试剂盒可增加簇密度和读长，从而提高测序质量分值。
TruSight Oncology 500
使用涵盖所有主要变异类别以及来自FFPE组织的基因特征（TMB、MSI和HRD）的大型泛癌panel实现CGP。
Illumina DNA Prep
快速、集成的文库制备工作流程，适用于各种测序应用。
NovaSeq 6000Dx试剂盒
这些测序试剂盒允许临床实验室在NovaSeq 6000Dx仪器上进行高通量体外诊断检测。
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