Controls & Reference Materials

CUSTOM NGS CONTROLS

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NGS Controls & Reference Materials

Reproductive Health

Non-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. 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 practice of using remnant patient samples or homebrew controls is not robust, reliable, or sustainable in the long run, especially in an environment of growing regulatory oversight.

SeraCare’s Seraseq™ reproductive health product line fulfills a critical market need by providing precisely formulated, known, and consistent NIPT reference materials to assess common trisomies such as trisomy 21, trisomy 18, and trisomy 13. This is especially important as more and more labs scale up their operations and need to develop, optimize, validate, and monitor ongoing assay performance.

Patient-like materials to optimize, validate, and standardize your assay

Reproductive Health Products

Reference materials built from true trisomic DNA derived from placental trophoblast cells
Size distribution profile similar to natural cfDNA (fragmented to ~170 bp)
Precise formulation of fetal fraction from 1% up to 12% to enable assay characterization
Maternal-fetal mixture is encapsulated and in synthetic plasma for patient-like commutability
Customizable through our VariantFlex custom NGS platform
Manufactured in GMP-compliant and ISO 13485-certified facilities

PRODUCT LIST

Product Name	Material Number	Size	Price	Unit	Qty
Seraseq Trisomy 21 Male Matched Reference	0720-0167	1 x 1 mL	Please sign in to view pricing.	EA	View Details
Seraseq® Trisomy 21 Aneuploidy Reference Material	0720-0019	1 x 1.0 mL	Please sign in to view pricing.	EA	View Details
Seraseq® Trisomy 21 Aneuploidy Linearity Panel (1-8% Fetal Fraction)	0720-0052	4 x 1.0 mL	Please sign in to view pricing.	EA	View Details
Seraseq® Trisomy 21, 18 and 13 Multi-Analyte Aneuploidy Reference Material	0720-0002	1 x 1.0 mL	Please sign in to view pricing.	EA	View Details
Seraseq® Trisomy 18 Aneuploidy Reference Material	0720-0018	1 x 1.0 mL	Please sign in to view pricing.	EA	View Details
Seraseq® Trisomy 13 Aneuploidy Reference Material	0720-0017	1 x 1.0 mL	Please sign in to view pricing.	EA	View Details
Seraseq Euploid Female Matched Reference Material	0720-0170	1 x 1 mL	Please sign in to view pricing.	EA	View Details
Seraseq® Aneuploidy Negative (Euploid) Reference Material	0720-0020	1 x 1.0 mL	Please sign in to view pricing.	EA	View Details

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