Liquid Biopsy

Seraseq® ctDNA Complete™ Mutation Mix AF5%

Material Number 0710-0528
Size 1 x 25 µL
Inventory Status Backorder: Available Soon
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 including 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 available: wild-type, 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 and ISO 13485-certified facilities.

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

Doc type
Package Insert

Seraseq ctDNA Complete Mutation Mix Non-Requirement Letter

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq ctDNA Complete Mutation Mix AF5%

Doc type
Product Report
Lot #
10346885

Seraseq ctDNA Complete Mutation Mix AF5%

Doc type
Technical Product Report
Lot #
10650559

Seraseq ctDNA Complete Mutation Mix AF5%

Doc type
Technical Product Report
Lot #
10559775

Seraseq ctDNA Complete Mutation Mix AF5%

Doc type
Technical Product Report
Lot #
10597915

Seraseq ctDNA Complete Mutation Mix AF5%

Doc type
Product Report
Lot #
10456865

Seraseq ctDNA Complete Mutation Mix AF5%

Doc type
Product Report
Lot #
10509970

Seraseq ctDNA Complete Mutation Mix Technical Spreadsheet

Doc type
Technical Spreadsheet

Seraseq ctDNA Complete Mutation Mix

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq ctDNA Complete

Doc type
Product Sheet
Lot #
-

Seraseq ctDNA Complete Mutation Mix AF5%

Doc type
Technical Product Report
Lot #
10680179
Product Specifications
# of Variants 25
Allele Frequency 5%
Fragment Size ~170bp
Concentration 10ng/µL
Fill Size 25 µL
Total DNA 250 ng
Buffer Tris/EDTA (TE)

 

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. 

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