NGS Controls & Reference Materials
Reproductive Health
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, and trisomy 13 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.
The Right Formats to Optimize, Validate, and Standardize Your Assay
*The 22q11 microdeletion size is approximately 2Mb, which is below the current 7Mb detect limit for VeriSeq
Seraseq NIPT reference standards are easily customizable using our VariantFlex custom platform. Click here to get started.
