Non-invasive prenatal testing (NIPT) continues to expand globally, driven by rapid technological improvements in next-generation sequencing (NGS) methodologies and growing market acceptance. However, given the importance of these test results towards patient management decisions, it is extremely critical that NIPT assays produce accurate and consistent results. The use of remnant patient samples or homebrew controls are not robust, reliable, or sustainable in an environment of growing regulatory oversight.
Seraseq Trisomy 21 Aneuploidy Linearity Panel (FF1-8) is a full-process reference material for NGS based NIPT assays designed to detect Trisomy 21 (Down syndrome) in cell-free DNA (cfDNA) circulating in the maternal bloodstream. This product can be used during development, validation, run monitoring, or troubleshooting to assess assay performance.
Key features include:
Male fetal DNA derived from placental trophoblast cells with a confirmed trisomy (under exclusive license), and blended with unrelated maternal DNA obtained from non-pregnant female DNA
Fragmented to ~170 bp size distribution to be consistent with native cfDNA
Offered in a full-process plasma-like material capable of assessing the entire workflow from extraction through analysis (identical to clinical samples)
4 vial kit with varying fetal fraction from 8% down to 1% allows for reliable assessment of assay LOD
Fetal fraction levels precisely quantitated with digital PCR (12% for each trisomy)
Manufactured in GMP-compliant and ISO 13485-certified facilities