NGS Controls & Reference Materials
NIPT
SHOP PRODUCTSNon-invasive prenatal testing (NIPT) continues to expand globally, driven by rapid technological improvements in next-generation sequencing (NGS) methodologies and growing acceptance by patients, clinicians, regulatory agencies, and reimbursement stakeholders. The resulting high test volumes, increased competition, and expanding regulatory oversight puts an ever-brighter spotlight on the accuracy and consistency of results.
The world’s leading NIPT assay developers and clinical labs have long recognized that the routine use of patient-like, sustainable, and consistent reference materials are crucial for monitoring and ensuring the performance of NIPT assays.
Patient-like Seraseq® NIPT reference standards ensure consistent, accurate results for a variety of chromosomal anomalies, such as trisomy 21, trisomy 18, trisomy 13, Jacobs Syndrome (XYY), Klinefelter Syndrome (XXY) and Turner Syndrome (XO), on major NIPT platforms.
- Detect assay drift before results are affected with patient-like, full-process reference materials
- Accelerate assay implementation and troubleshooting with a sustainable source of highly consistent reference materials
- Reduce costs with easily customizable standards containing precisely quantitated rare and difficult-to-detect microdeletions
- Enhance NGS workflow performance and data quality with more efficient library preparation thanks to natural cfDNA-like size distribution
Matched patient-like materials to optimize, validate, and standardize your assay
- Reference materials built from cfDNA derived from pregnant women
- Matched maternal-fetal material for compatibility with most NIPT methods
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Figure 1. Size profile of cfDNA. Native circulating cell-free DNA is shown in orange, SeraCare cell-free DNA in blue, and randomly sheared DNA in green.
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Figure 2. Allows determination of limit of detection using different levels of fetal fraction. See data as originally presented here.
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Un-matched patient-like materials to optimize, validate, and standardize your assay
- Reference materials built from true trisomic DNA derived from placental trophoblast cells
- Compatible only with chromosome counting methods or non-NGS methods
Figure 3. SeraSeq NIPT reference materials perform the same as patient's samples. Red line represents a cut-off of SD value. Circled in green and red are SeraSeq materials, trisomy 21 and euploid respectively.
Data courtesy of Laboratoire Cerba.
