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Quality Controls & Reference Standards
SensID Distributed by Goffin Diagnostics

5-Gene-Multiplex Set cfDNA

The 5-Gene-Multiplex Set cfDNA (SID-000095) is a dilution series of one reference material at four allele frequencies: 0, 0.1, 1 and 5 per cent. The set comprises SID-000003, SID-000092, SID-000093 and SID-000094. The panel covers mutations in AKT1, BRAF, ERBB2, KRAS and PIK3CA, in human cfDNA from characterised cell lines. Four levels including a zero point are what allow a limit of detection and a dose response to be established rather than a single pass or fail.

Reagens SensID Unit Size: 400 ng
Technique
Reagens
Brand
SensID
Packaging
Unit Size: 400 ng
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Product details

This kit in detail

  • Four allele frequencies: 0, 0.1, 1 and 5 per cent
  • Components SID-000003, SID-000092, SID-000093 and SID-000094
  • Mutations in AKT1, BRAF, ERBB2, KRAS and PIK3CA
  • Human cfDNA from characterised cell lines
  • For qualitative and quantitative validation of liquid biopsy assays

The 5-Gene-Multiplex Set cfDNA supplies the same mutation panel at four allele frequencies, so an assay can be characterised over a range instead of at a single point.

The four levels

0 per cent as the wild-type and blank level, then 0.1, 1 and 5 per cent. With those four points the limit of blank, the limit of detection and the linearity of quantification can be established, and a run control at a level close to the clinical decision point can be chosen.

Genes covered

AKT1, BRAF, ERBB2, KRAS and PIK3CA. These genes are relevant across a wide range of tumours, including breast, colorectal, lung, pancreatic and ovarian carcinoma and melanoma.

Applications

Validation and development of diagnostic kits, optimisation of internal processes, and use as an allele frequency standard in liquid biopsy assays in diagnostic and R&D laboratories. The individual levels are also available separately, for example the 0.1 per cent level in a plasma matrix as SID-000088.

  •  5-Gene-Multiplex Set cfDNA
Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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