VeriSeq NIPT Solution v2

Comprehensive in-lab NIPT IVD solution including reagents, instruments, and software for accurate aneuploidy screening results in 26 hours.

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Overview

Veriseq NIPT v2 is a streamlined, accessible NIPT solution that provides clinicians with results they can trust. 

  • A simple, easy-to-use, automated IVD prenatal screening solution that easily integrates into your lab's current workflow and flexes with your lab's growing needs

  • ≥ 99.9% sensitivity and specificity for trisomy 21, 18, and 131

  • Fast workflow with minimal hands-on time, enabling sample to report in ~26 hours 

Comprehensive screening

Broad test menu expands prenatal screening beyond aneuploidies 21, 18, and 13 to all rare autosomal aneuploidies (RAAs), sex chromosome aneuploidies (SCAs) and partial duplications and deletions ≥ 7 Mb for all autosomes. As a result, VeriSeq NIPT v2 detects anomalies that targeted assays miss to deliver more insights into the health of a pregnancy. 

Integrated and flexible workflow

VeriSeq NIPT v2 offers a simple, scalable IVD solution that can analyze 24, 48, or 96 samples per run. Sample preparation is automated on the VeriSeq NIPT Microlab STAR system from Hamilton Robotics. 

Trusted and reliable results

VeriSeq NIPT v2 is an extensively validated NIPT with a low test failure rate (1.2%) and high concordance with clinical reference data. 1 


Intended use

The VeriSeq NIPT Solution v2 is an in vitro diagnostic test intended for use as a screening test for the detection of genome-wide fetal genetic anomalies from maternal peripheral whole blood specimens in pregnant women of at least 10 weeks gestation. VeriSeq NIPT Solution v2 uses whole-genome sequencing to detect partial duplications and deletions for all autosomes and aneuploidy status for all chromosomes. The test offers an option to request the reporting of sex chromosome aneuploidy (SCA). This product must not be used as the sole basis for diagnosis or other pregnancy management decisions. The VeriSeq NIPT Solution v2 includes: the VeriSeq NIPT Workflow Manager v2 for the VeriSeq NIPT Microlab STAR, the VeriSeq NIPT Sample Prep Kits, and the VeriSeq Onsite Server v2 with the VeriSeq NIPT Assay Software v2. The VeriSeq NIPT Solution v2 is intended to be used with a next-generation sequencer. 

 

For In Vitro Diagnostic Use 

Contact an Illumina representative for regional availability. 


Specifications


Required products

Requires purchase of a VeriSeq NIPT Sample Prep Kit configured for 24, 48, or 96 samples. Other required products include: 

  • A one-time purchase of the VeriSeq NIPT Solution Enablement and VeriSeq Onsite Server v2 

  • The NextSeq 550Dx Sequencing System, a next-generation sequencing instrument  

  • VeriSeq NIPT Microlab STAR, a liquid-handling robot for automation of all sample preparation steps sold by Hamilton Robotics and includes the VeriSeq NIPT Workflow Manager Software 

  • Additional instruments and labware as specified in the VeriSeq NIPT Solution Consumables and Equipment Guide under Manuals and Support Information  

/ Results

Applications

VeriSeq NIPT Solution v2 provides comprehensive screening of fetal chromosomes for informed and timely pregnancy management decisions.1 

VeriSeq NIPT Solution v2 Enablement Schedule*

1
Installation and training
Weeks 1-4
Contract Signed
  • Consumables and Equipment List provided
  • Lab begins process of procuring required components
  • Welcome Letter sent with implementation/training timeline example
Intro to Assay Seminar
  • Overview of workflow and analysis
  • Review Consumables and Equipment List
  • Blood Draw Protocol
  • Plasma Isolation Protocol
Instrument Operation Training
  • Illumina Sequencing (requires install of sequencer)
2
Site inspection
Week 5

Onsite visit from Illumina staff to confirm all required equipment installed, consumables present, and connectivity of sequencer to analysis server

3
Onsite training
Week 6-7
Hands-on, onsite training by qualified Illumina Field Applications Scientist
  • Performance qualification and training run performed during onsite training
  • Pre-tested Plasma Samples (with known performance characteristics provided by Illumina)
  • Assay workflow from plasma through Illumina Sequencer operation and data analysis
  • One flow cell (48 samples)
  • Training on data analysis
  • Training certificate provided for all trainees
4
Competency training
Week 6-7
  • Laboratory staff processes pre-tested plasma samples (with known performance characteristics provided by Illumina)
  • Four flow cells (48 plasma samples per flow cell)
  • Competency data assessed by highly trained Illumina staff
  • Competency report provided to the lab

*Schedule shown is an estimate. Timelines may vary from lab to lab. 


Related applications and methods

Figures

Full IVD NIPT workflow

All components provided, including reagents for DNA extraction, library prep, and sequencing; instrumentation to automate library prep and sequencing with Workflow Manager software; an onsite server for secure data storage and analysis; and data analysis software to generate a report.

VeriSeq NIPT Solution v2 delivers results trusted by clinicians

a. Basic screen performance; excludes 16 samples with known mosaics and 49 samples with anomalies for the genome-wide screen only; genome-wide screen performance is reported for RAAs and CNVs.
b. 7 twin pregnancies reported correctly as T21 not shown.
c. Excludes chromosomes 21, 18, and 13.1 

Fetal sex classification concordance with cytogenic results

Resources

Discover the ease, accuracy, and speed that VeriSeq NIPT can bring to your lab. 

Find out how the VeriSeq NIPT workflow detects aneuploidy in three simple steps.

European labs share their experiences implementing NIPT.

VeriSeq NIPT Sample Prep Kit(24 Samples)

20025895

The VeriSeq NIPT Sample Prep Kit – 24 is used with the VeriSeq NIPT Solution – a screening test for the detection of fetal aneuploidies across the genome and genomewide CNV. The kit includes reagents and consumables for the extraction, library preparation and quantitation of cell free DNA fragments isolated from 24 maternal whole blood samples.

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VeriSeq NIPT Sample Prep Kit(48 samples)(Formerly RH-200-1001)

15066801

Includes reagents for extraction, library preparation, and quantitation of cell-free DNA fragments isolated from 48 maternal whole blood samples. Purchase NextSeq 550Dx sequencing reagents separately.

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VeriSeq NIPT Sample Prep Kit(96 samples)(Formerly RH-200-1002)

15066802

Includes reagents for extraction, library preparation, and quantitation of cell-free DNA fragments isolated from 96 maternal whole blood samples. Purchase NextSeq 550Dx sequencing reagents separately.

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Streck cell free DNA BCT CE

15073345

CE marked cell-free DNA blood collection tube: a 10 mL blood collection tube which contains a formaldehyde-free preservative that stabilizes white blood cells, preventing the release of genomic DNA and allowing for isolation of high-quality cell-free DNA. Samples collected in this tube should be stored and shipped at room temperature and must be received by laboratory within 5 days. Quantity = pack of 100 tubes

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NextSeq™ 550Dx Sequencing System

20005715

The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic assays performed on the instrument. The NextSeq 550Dx instrument is to be used with specific registered, certified or approved in vitro diagnostic reagents and analytical software.The instrument includes a dual boot configuration to enable the use of the instrument in either diagnostic (Dx) or research use only (RUO) mode. In vitro diagnostic sequencing assays, including the Germline and Somatic Variant Modules, are executed in diagnostic mode. Only IVD sequencing reagents can be utilized in diagnostic mode.

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VeriSeq NIPT Solution Enablement

RH-500-1001

Includes installation of the VeriSeq Onsite Server v2, hands-on, in-lab training and workflow instruction as well as workflow competency testing. This is a required one-time purchase when implementing the VeriSeq NIPT Solution v2.

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VeriSeq Onsite Server v2

20028403

IVD-marked, onsite server that assesses sequencing data to screen for fetal aneuploidy of all chromosomes, including 21, 18, 13, X, and Y. This is a required one-time purchase when implementing the VeriSeq NIPT Solution.

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FAQs

VeriSeq NIPT Solution v2 uses powerful Illumina next-generation sequencing (NGS) to bring a PCR-free, whole-genome sequencing (WGS) approach to noninvasive prenatal testing, using a single tube of maternal blood at as early as 10 weeks gestation.2,3 This integrated solution provides everything needed to run the assay with a scalable workflow. Your lab can choose to run basic or genome-wide screening by sample.

After data analysis, the VeriSeq NIPT Assay Software v2 generates an “Aneuploidy detected” or “No aneuploidy detected” result for the chromosomes tested in each sample. If a partial deletion or duplication is detected, the exact coordinates in the genome are displayed in the report. Information output is a ".tab" file that can be integrated with an existing LIMS. Data can be used to create a custom clinical report.

VeriSeq NIPT Solution v2 requires 7–10 ml of maternal peripheral whole blood collected in the recommended Streck Blood Collect Tube (BCT).

The basic screen provides information on the trisomy status for chromosomes 21, 18, 13, X, and Y only. Genome-wide screens provide partial deletions and duplications of ≥ 7 Mb or more for all autosomes and aneuploidy status for all chromosomes. In some countries, depending on regulations, fetal sex reporting and sex chromosome aneuploidy (SCA) reporting is not available.

The solution is performed on three primary pieces of equipment: 

  • A VeriSeq NIPT MicroLab STAR from Hamilton 

  • NextSeq 550Dx Instrument 

  • A VeriSeq Onsite Server v2 or an existing VeriSeq Onsite Server upgraded to version 2 

Additional lab equipment is necessary to complete a run. Refer to the VeriSeq NIPT Solution v2 Consumables and Equipment List for a full list of required equipment. 

/ Results

Frequently purchased

NextSeq 550Dx Reagents

These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing on the NextSeq550 Dx Instrument.

VeriSeq NIPT Solution v2

Comprehensive in-lab NIPT IVD solution including reagents, instruments, and software for accurate aneuploidy screening results in 26 hours.

References

  1. Pertile MD, Flowers N, Vavrek D, et al. Performance of a paired-end sequencing-based noninvasive prenatal screening test in the detection of genome-wide fetal chromosomal anomalies. Clin Chem. 2021;67(9):1210-1219. doi:10.1093/clinchem/hvab067
  2. Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012;119(5):890-901. doi:10.1097/AOG.0b013e31824fb482
  3. Bianchi DW, Parker RL, Wentworth J, et al. CARE Study Group: DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014;370:799-808. doi:10.1056/NEJMoa1311037

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