5-Gene-Multiplex Set cfDNA in Plasma, BRAF/KRAS/PIK3CA/AKT1/ERBB2; AF: 0%; 0.1%; 1%; 5%

The selected genes and mutations are diagnostically and therapeutically highly relevant and also play a role in various tumor entities:

Breast Carcinoma,  Colorectal Carcinoma,  Melanoma, Non-Small Cell Lung Carcinoma,  Small Cell Lung Carcinoma,  Prostate Carcinoma,  Lymphoma,  Head and Neck Carcinoma,  Hepatocellular Carcinoma,  Multiple Myeloma,  Pancreatic Adenocarcinoma,  Ovarian Carcinoma,  Bladder Carcinoma, Bile Duct Carcinoma and more.

The 5-Gene-Multiplex Set cfDNA in plasma product can be used in diagnostics as an allelic frequency standard range in liquid biopsy assays in your laboratory or R&D department, as well as for validation and development of diagnostic kits. Background material is highly characterized human cfDNA from cell lines. The set consists of the individual products SID-000002, SID-000088, SID-000089 and SID-000090 and can be used to validate your internal processes qualitatively and quantitatively with 0%, 0.1%, 1% and 5% allelic frequency.

SKU: SID-000091 Category:

Product description

These products are ideal for digital PCR and/or Next Generation Sequencing (NGS). In particular:
– Validation and development of sequencing protocols (e.g. Whole Genome Sequencing (WGS), Amplicon Sequencing) and PCR protocols
– Determination of the detectiont limit of the method
– to control the extraction efficiency

Unit Size:
80 ng/ml (total 400 ng)

5 ml of Plasma in each vial

Mutations:

  • AKT1 – p.E17K (COSV62571334*, Substitution, c.49G>A)
  • BRAF – p.V600E (COSV56056643*, Substitution, c.1799T>A)
  • ERBB2 – p.Y772_A775dup (COSV54062409*, Insertion, c.2323_2324dup)
  • KRAS – p.G12D (COSV55497369*, Substitution, c.35G>A)
  • KRAS – p.Q61K (COSV55502066*, Substitution, c.181C>A)
  • KRAS – p.A146T (COSV55501778*, Substitution, c.436G>A)
  • PIK3CA – p.E545K (COSV55873239*, Substitution, c.1633G>A)
  • PIK3CA – p.H1047R (COSV55873195*, Substitution, c.3140A>G)

Allelic frequency:
0%; 0.1%; 1%; 5%

Buffer:
Plasma (human-tech)

Storage:
2-8 °C

Expiry:
stable for 12 months from date of manufacture (as supplied)

Quality control

Fragmentation size:
High Sensitivity DNA Kit Agilent

Allelic Frequency/copy number (metrologically traceable):
dPCR

Quantification (metrologically traceable):
1. UV-Vis Spectrophotometry (NIST-Reference method) for measurement of total DNA

2. dsDNA

Technical background

Derived from:
cell line GM24385 (HG002- NA24385 – huAA53E0)

Bioinformatics:
– lot specific sequencing files: LOT Search
– High-confidence variant calls: ftp://ftp-trace.ncbi.nlm.nih.gov/giab/ftp/release/AshkenazimTrio
– Raw datasets and bam files, currently including 10X Genomics, BioNano, Complete Genomics regular and LFR, 300x Illumina paired-end, Illumina 6kb mate-pair, 1000x Ion exome, custom molecular libraries, ~0.05x Oxford Nanopore, and 70x/30x/30x PacBio: ftp://ftp-trace.ncbi.nlm.nih.gov/giab/ftp/data/AshkenazimTrio/HG002_NA24385_son/

*GRCh 38 Cosmic v90

Documents

Certificate of Analysis:

Batch Certificate

other Documents:

Safety Data Sheet (SDS in other languages ​​available on request. Please contact the support.)

Instructions