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Manufacturer

Illumina

Application

The NIPT CE-IVD by Illumina 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

NIPT CE-IVD by Illumina 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.
  • 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

NIPT CE-IVD by Illumina 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 NIPT CE-IVD by Illumina  to detect anomalies that targeted assays miss and deliver more insights into the health of a pregnancy.

Fast results

Extensive validation of the NIPT CE-IVD by Illumina  confirmed high concordance with clinical reference data and a low test failure rate of 1.2%. An efficient 3-step workflow allows sample to report in 26 hours.

Automated solution

Biomedic's solution

Assay Time 26 Hours
Method Whole-Genome Sequencing
System Compatibility NextSeq 550Dx
Nucleic Acid Type DNA
Technology Sequencing

Product

Next Generation Sequencing System – NextSeq 550

Model: Nextseq 550
Manufacturer: Illumina/USA
– Is the only sequencing system capable of deploying applications running sequencing and reading microarray biochips
– New generation DNA sequencing system using synthetic sequencing technology: Sequencing by Synthesis – SBS
– The whole process of gene sequencing is conducted on the surface of flow cells, convenient to use and easy to manipulate.

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Manufacturer

Illumina

Application

The NIPT CE-IVD by Illumina 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