Seraseq™ Trisomy 21 Aneuploidy Linearity Panel (1-8% Fetal Fraction)
Seraseq Trisomy 21 Aneuploidy Linearity Panel (FF1-8) is a full-process reference material for NGS based non-invasive prenatal testing (NIPT) assays designed to detect trisomy 21 (Down syndrome) in cell-free DNA (cfDNA) circulating in the maternal bloodstream. This product provides clinical labs and assay developers with consistent, readily available reference material to primarily assess the assay limit of detection (LOD) during assay development and validation.
True trisomic DNA as the fetal fraction source
Male fetal DNA is derived from placental trophoblast cells with a confirmed trisomy (under exclusive license). Maternal DNA is unrelated and obtained from non-pregnant female DNA (euploid).
Size distribution profile similar to authentic cell-free DNA
DNA is fragmented to ~170bp to mimic cfDNA sizing for simplified library preparation.
Precisely tuned fetal fraction amount
Precise formulation and digital PCR quantitation of fetal fraction. Panel of varying fetal fraction amount down to 1% allows for reliable assessment of assay LOD.
Biosynthetic DNA mixture is stabilized, encapsulated, and introduced into plasma-like matrix material
Supports maximum commutability; behaves like a true clinical sample and follows identical process workflow from extraction through data analysis.
Reproducible, consistent production process
Highly characterized manufacturing process in cGMP compliant, ISO-9001, and ISO 13485-certified facilities.
For research use only. Not for use in diagnostic procedures.