Seraseq® ctDNA Complete™ Reference Material

To further accelerate the validation and clinical application of liquid biopsy-based ccfDNA targeted NGS assays, SeraCare has developed the Seraseq ctDNA Complete that expands coverage of all relevant variant types (SNVs, INDELs, CNVs, and gene fusions) in a single, highly multiplexed reference sample. These new products are offered in either a purified ctDNA format or a plasma-like matrix format, all precisely quantitated by digital PCR against a single well-characterized genomic background (GM24385), and orthogonally validated with NGS technology.

• 25 unique multiplexed variants in 16 genes, covering 12 SNVs, 7 INDELs, 3 CNVs, and 3 SVs, in purified and plasma-like matrix formats
• 6 different allele frequencies (AF) – WT, 0.1%, 0.5%, 1%, 2.5% and 5%
• Allows end-to-end evaluation of assay performance across the entire workflow, including pre-analytic extraction steps
• Variants quantitated with digital PCR and orthogonally validated by NGS
• Blends with well-characterized GM24385 human genomic DNA as background ‘wild-type’ material
• Manufactured within cGMP compliant, ISO 9001 and ISO 13485 certified facilities

Specifications

Documents

• Seraseq ctDNA Complete Reference Materials Package Insert (Package Insert)
• Technical Spreadhseet for Seraseq ctDNA Complete Mutation Mix and Reference Material (Technical Spreadsheet)
• Seraseq ctDNA Complete Reference Material Non-Requirement Letter (SDS Non-Requirement Letter)

Ordering Information