In-Lab Screening Using NIPT
Veriseq NIPT Solution v2 + You:
Ease, accuracy2, and speed are just the beginning
More from your lab with VeriSeq NIPT Solution v2
Provide clinicians with a comprehensive menu of prenatal screening options including:1
Trisomy 21, 18, 13
Rare autosomal aneuploidies (RAAs)
Sex Chromosome Abnormalities (SCAs)
Partial duplications AND deletions ≥7MB for all autosomes
VeriSeq NIPT Solution v2 scales according to your lab’s needs, through customized menu selection for each individual sample and versatile batch options. With a long-lasting partnership committed to your lab’s growth and continued success, together, we can shape the future of prenatal testing.
Deliver ease, accuracy, and speed to your lab with an end-to-end workflow, high accuracy, and low failure rates with VeriSeq NIPT Solution v2.
VeriSeq NIPT Solution v2 delivers high accuracy with ≥99.9% sensitivity and specificity.2 Results that you and your clinicians can trust.
| Trisomy 21b2 | Trisomy 182 | Trisomy 132 | RAAc2 | Partial Duplications and Deletions ≥7 MB2 | |
|---|---|---|---|---|---|
| Sensitivitya | >99.9% | >99.9% | >99.9% | 96.4% | 74.1% |
| Specificity | >99.90% | >99.90% | >99.90% | >99.80% | >99.80% |
- 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.2
- b. Seven twin pregnancies reported correctly as T21 are not shown in the table.2
- c. RAA excludes chromosomes 21, 18, and 132
Performance backed by published clinical experience data from over 40,000 samples2,4—6
Screening with VeriSeq NIPT includes dynamic fetal fraction measurement, which means lower failure rates, fewer redraws, trusted results for the clinician, and more answers delivered earlier to expecting families.2
Results in 26 hours when you choose VeriSeq NIPT Solution v23
From sample to result, all it takes is 1 technician and 2 hours of hands-on time to deliver results in about 1 day.
Rest assured that you can report timely prenatal screening results to your clinicians. The dedicated service and support team at Illumina is available for on-site assistance and phone and email communication when you need it the most.
| Sample and Library Prep | Sequencing | Data Analysis and Report Generation | Total Overall Time | |
|---|---|---|---|---|
| Hands-On Time | ~2 hours | ~15 minutes | ~2.25 hours | |
| Total Time | ~8 hours | ~14 hours | ~4 hours | ~26 hours |
Actual times depend on individual lab practices and may vary; the depiction shown represents a 48-sample workflow.
Choose VeriSeq NIPT Solution v2 for the NIPT offering that fits easily into your lab
Versatile batch options for 24, 48, or 96 samples per run
Customized menu selections for each sample
VeriSeq NIPT Solution v2 is a complete end-to-end in vitro diagnostic system that enables a streamlined workflow. It’s 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. This next-generation sequencing-based, PCR-free platform provides a small footprint and less complexity for the lab.
The workflow that works with you:
Ease
A simple, easy-to-use, automated system seamlessly integrates into your lab’s current workflow, and flexes with your lab’s growing needs.1
Accuracy
This in-lab IVD NIPT assay solution delivers high accuracy with a ≥99.9% sensitivity and specificity, for results that you and your clinicians can trust.2
Speed
Results are delivered in approximately 26 hours with only 2 hours of hands-on time—clinicians and expectant families get answers faster.3
Resources
Learn more about VeriSeq NIPT Solution v2 and how it can fit into your lab.
VeriSeq NIPT Solution v2 and Your Lab
Download the VeriSeq NIPT Solution v2 brochure.
NIPT Technology Guide
Find the right fit for your lab with Illumina by exploring key considerations.
The Value of NIPT with Illumina
Learn how NIPT has become the standard for prenatal screening.
The NIPT Process with VeriSeq Solution v2
Delve into the NIPT process step by step.
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.
Limitations of the Test
Noninvasive prenatal testing (NIPT) based on cell-free DNA analysis from maternal blood is a screening test; it is not diagnostic. False positive and false negative results do occur. Test results must not be used as the sole basis for diagnosis. Further confirmatory testing is necessary prior to making any irreversible pregnancy decision. A negative result does not eliminate the possibility that the pregnancy has a chromosomal or sub chromosomal abnormality. This test does not screen for polyploidy (eg, triploidy), birth defects such as open neural tube defects, single gene disorders, or other conditions, such as autism. There is a small possibility that the test results might not reflect the chromosomal status of the fetus, but may instead reflect chromosomal changes in the placenta (confined placental mosaicism, CPM) or the mother that may or may not have clinical significance.
References
- VeriSeq NIPT Solution v2 [package insert]. San Diego, CA: Illumina; 2021.
- 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.
- VeriSeq NIPT Solution v2 [data sheet]. San Diego, CA: Illumina; 2021.
- Borth H, Teubert A, Glaubitz R, et al. Analysis of cell-free DNA in a consecutive series of 13,607 routine cases for the detection of fetal chromosomal aneuploidies in a single center in Germany. Arch Gynecol Obstet. 2021;303:1407-1414.
- Eiben B, Borth H, Kutur N, et al. Clinical experience with noninvasive prenatal testing in Germany: analysis of over 500 high-risk cases for trisomy 21, 18, 13, and monosomy X. Obstet Gynecol Rep. 2021;5:1-7.
- Kleinfinger P, Lohmann L, Luscan A, et al. Strategy for use of genome-wide non-invasive prenatal testing for rare autosomal aneuploidies and unbalanced structural chromosomal anomalies. J Clin Med. 2020;9(8);2466.