VeriSeq NIPT Solution v2
Comprehensive, IVD, in-lab aneuploidy screening solution providing reagents, instruments, and software for accurate NIPT results in 26 hours.
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Product Highlights
VeriSeq NIPT Solution v2 makes NGS-based noninvasive prenatal testing accessible to any lab, providing:
- Ease: A simple, easy-to-use, automated prenatal screening solution that easily integrates into your lab's current workflow and flexes with your lab's growing needs.
- Accuracy: ≥99.9% sensitivity & specificity for trisomy 21, 18, and 13.1
- Speed: From sample to result in about 1 day, requiring only 1 technician and 2 hours of hands-on time.
Comprehensive screening beyond common aneuploidies
VeriSeq NIPT Solution v2 uses PCR-free, whole-genome sequencing to expand 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. This enables the VeriSeq NIPT Solution v2 to detect anomalies that targeted assays miss and deliver more insights into the health of a pregnancy.
Fast results
Extensive validation of the VeriSeq NIPT Solution v2 confirmed high concordance with clinical reference data and a low test failure rate of 1.2%.1 An efficient 3-step workflow allows sample to report in 26 hours.
Automated solution
Sample preparation is automated on the VeriSeq NIPT Microlab STAR system, optimized for use in the VeriSeq NIPT workflow. Learn more on the Hamilton website.
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Specifications
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.
Full IVD NIPT Workflow
The VeriSeq NIPT Solution v2 provides everything needed for NIPT using NGS, 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 capable of generating a report that provides qualitative results.
VeriSeq NIPT Solution v2 delivers high accuracy with ≥99.9% sensitivity and specificity.1
Results that you and your clinicians can trust.
a. Basic screen performance is reported for T21, T18, and T13 and excludes 16 samples with known mosaics and 49 samples affected with anomalies for the genome-wide screen only; genome-wide screen performance is reported for RAAs and CNVs.1
b. Seven twin pregnancies reported correctly as T21 are not shown in the table.1
c. RAA excludes chromosomes 21, 18, and 13.1
Fetal sex classification concordance
Cytogenetic results1
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References
- 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
Product Literature
Data Sheet | PDF | 13 versions
Manuals and Support Information
VeriSeq NIPT Solution v2 Software Guide Documentation
VeriSeq NIPT Solution v2 Package Insert Documentation
VeriSeq NIPT Solution v2 Consumables & Equipment List Documentation
Veriseq NIPT Solution Documentation
VeriSeq NIPT WFM 2.5.7 Release Notes Documentation
VeriSeq NIPT Solution v2 Sample Prep Checklist Documentation