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 13 1
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.
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*
Consumables and Equipment List provided
Lab begins process of procuring required components
Welcome Letter sent with implementation/training timeline example
Overview of workflow and analysis
Review Consumables and Equipment List
Blood Draw Protocol
Plasma Isolation Protocol
Illumina Sequencing (requires install of sequencer)
Onsite visit from Illumina staff to confirm all required equipment installed, consumables present, and connectivity of sequencer to analysis server
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
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
Noninvasive prenatal testing
Noninvasive prenatal testing (NIPT) analyzes cell-free DNA from a maternal blood sample to screen for common chromosomal conditions as early as the first trimester.
Cell-free DNA and NIPT
Understanding cell-free DNA and its impact on fetal aneuploidy detection.
NIPT vs. traditional aneuploidy screening methods
Although both are aneuploidy screens, maternal serum screening and NIPT blood tests have different accuracy rates, time to results, and implementation.
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. 1 b. 7 twin pregnancies reported correctly as T21 not shown. 1 c. Excludes chromosomes 21, 18, and 13. 1
Resources
VeriSeq NIPT Solution v2: Expect the extraordinary in prenatal screening
Discover the ease, accuracy, and speed that VeriSeq NIPT can bring to your lab.
The science behind NIPT
Find out how the VeriSeq NIPT workflow detects aneuploidy in three simple steps.
The value of VeriSeq NIPT Solution v2
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. View less
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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. View less
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. View less
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 View less
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. View less
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. View less
VeriSeq Onsite Server v2
20047000
VeriSeq Onsite server with newer generation Hardware. The VeriSeq Onsite Server includes both the VeriSeq NIPT Assay Software and Workflow Manager. The Assay software output provides statistics which can be used to assess over or under representation of all autosomes and CNV across the genome. View less
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How does VeriSeq NIPT work?
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.
What do VeriSeq NIPT test results look like?
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.
What is the sample type required for the VeriSeq NIPT test?
VeriSeq NIPT Solution v2 requires 7–10 ml of maternal peripheral whole blood collected in the recommended Streck Blood Collect Tube (BCT).
What is the difference between basic and genome-wide screens?
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.
What equipment do I need to run the VeriSeq NIPT Solution v2?
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.
