Liquid Biopsy

Seraseq® ctDNA Complete™ Reference Material AF5%

Material Number 0710-0669
Size 1 x 5 mL
Inventory Status In Stock
Unit EA

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.

This specific ctDNA Complete product has an allele frequency of 5%.

  • 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

Seraseq ctDNA Complete Reference Materials Package Insert

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Package Insert

Seraseq ctDNA Complete Reference Material AF5%

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Product Report
Lot #
10346905

Seraseq ctDNA Complete Reference Material AF5%

Doc type
Technical Product Report
Lot #
10632057

Seraseq ctDNA Complete Reference Material AF5%

Doc type
Technical Product Report
Lot #
10702080

Technical Spreadhseet for Seraseq ctDNA Complete Mutation Mix and Reference Material

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Technical Spreadsheet

Seraseq ctDNA Complete

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Product Sheet
Lot #
-

Seraseq ctDNA Complete Reference Material AF5%, AF2.5%, AF1%, AF0.5%, AF0.1%, WT (Wild-Type)

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Safety Data Sheet (Non-Requirement Letter)

Seraseq ctDNA Complete Reference Material Non-Requirement Letter

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq ctDNA Complete Reference Material AF5%

Doc type
Technical Product Report
Lot #
10659790

Seraseq ctDNA Complete Reference Material AF5%

Doc type
Product Report
Lot #
10438801

Seraseq ctDNA Complete Reference Material Technical Spreadsheet

Doc type
Technical Spreadsheet
Product Specifications
# of Variants 25
Allele Frequency 5%
Fragment Size ~170bp average
Concentration 25 ng/mL
Volume 5 mL
Amount 125 ng (single vial)
Matrix SeraCon™ Matribase (human plasma-like) 

 

NGS-Based Assay Compatibility Chart
Archer® Reveal ctDNA™ 28 Kit Oncomine® Pan-
Cancer Cell-Free Assay
Oncomine Lung
cfDNA Assay
Oncomine
Colon cfDNA
UltraSEEK™
Colon Panel
UltraSEEK
Lung Panel 
AKT1 AKT1 ALK AKT1 BRAF BRAF 
ALK ALK BRAF BRAF EGFR EGFR 
BRAF BRAF EGFR EGFR KRAS ERBB2 
EGFR EGFR ERBB2 ERBB2 NRAS KRAS
ERBB2 ERBB2 KRAS KRAS PIK3CA PIK3CA 
KIT KIT MET NRAS    
KRAS KRAS NRAS PIK3CA    
MET MET PIK3CA      
NRAS MYC ROS1      
PIK3CA NRAS        
RET PIK3CA        
Archer® is a registered trademark, and Reveal ctDNA™ is a trademark of ArcherDx, Inc.
Oncomine® is a registered trademark of Thermo Fisher Scientific.
UltraSEEK™ is a trademark of Agena Bioscience, Inc. 

Find more data and in-depth technical information by reading this Technical Product Report.

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