Comprehensive in-lab NIPT IVD solution including reagents, instruments, and software for accurate aneuploidy screening results in 26 hours.
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Veriseq NIPT v2 is a streamlined, accessible NIPT solution that provides clinicians with results they can trust.
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.
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.
VeriSeq NIPT v2 is an extensively validated NIPT with a low test failure rate (1.2%) and high concordance with clinical reference data. 1
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.
| Instruments | NextSeq 550Dx Instrument |
|---|---|
| Method | Whole-genome sequencing, NIPT sequencing |
| Nucleic acid type | DNA |
| Species category | Human |
| Technology | Sequencing |
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
VeriSeq NIPT Solution v2 provides comprehensive screening of fetal chromosomes for informed and timely pregnancy management decisions.1
Onsite visit from Illumina staff to confirm all required equipment installed, consumables present, and connectivity of sequencer to analysis server
*Schedule shown is an estimate. Timelines may vary from lab to lab.
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.
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.
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.
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
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 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.
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.
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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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.
These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing on the NextSeq550 Dx Instrument.
Comprehensive in-lab NIPT IVD solution including reagents, instruments, and software for accurate aneuploidy screening results in 26 hours.
A library preparation and enrichment solution for IVD targeted sequencing applications.
References
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