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5-Gene-Multiplex 0.1% AF cfDNA in Plasma

5-Gene-Multiplex 0.1% AF cfDNA in Plasma (SID-000088) is a reference material for liquid biopsy with mutations in five genes at an allele frequency of 0.1 per cent: AKT1 p.E17K, BRAF p.V600E, KRAS, PIK3CA p.E545K and p.H1047R, and ERBB2 p.Y772_A775dup. These variants occur in lung, breast and colorectal cancer and in melanoma, and each of them has a matching targeted treatment, which is why an assay has to detect them at a low mutant fraction.

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Product details

This kit in detail

  • Mutations in AKT1, BRAF, ERBB2, KRAS and PIK3CA, catalogue SID-000088
  • Allele frequency 0.1 per cent
  • AKT1 p.E17K, BRAF p.V600E, PIK3CA p.E545K and p.H1047R, ERBB2 p.Y772_A775dup
  • Positive control for digital PCR and NGS
  • Human cfDNA in a recreated plasma matrix

5-Gene-Multiplex 0.1% AF cfDNA in Plasma is a positive standard for a multi-gene liquid biopsy panel, at an allele frequency of 0.1 per cent.

Variants

AKT1 p.E17K; BRAF p.V600E; KRAS, in several variants; PIK3CA p.E545K and p.H1047R; and ERBB2 p.Y772_A775dup. The genes cover lung, breast and colorectal carcinoma and melanoma, and each variant has a corresponding targeted treatment, so a false negative has direct consequences for the patient.

Composition

The background is human cell-free DNA from the Ashkenazim son cell line, embedded in recreated human plasma that contains human proteins, electrolytes and EDTA at the concentrations found after a standard blood draw, with the EDTA concentration following the guidance of the International Council for Standardization in Haematology (ICSH) and the Clinical and Laboratory Standards Institute (CLSI).

Applications

Validation and development of sequencing and PCR protocols, determination of the limit of detection, and verification of variant calling at a low mutant fraction. The material is also available as part of a set with the levels 0, 0.1, 1 and 5 per cent (SID-000095).

5-Gene-Multiplex 0.1% AF cfDNA in Plasma

Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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