EGFR-Multiplex 0.1% AF cfDNA in Plasma
EGFR-Multiplex 0.1% AF cfDNA in Plasma (SID-000014) is a reference material for EGFR mutation testing on liquid biopsy. It contains a mix of TKI-sensitive and TKI-resistant EGFR mutations at an allele frequency of 0.1 per cent, in human cfDNA in a recreated plasma matrix. At 0.1 per cent the material sits at the sensitivity limit of most methods, which is what makes it suitable for determining the limit of detection of a digital PCR or NGS assay.
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This kit in detail
- TKI-sensitive and TKI-resistant EGFR mutations, catalogue SID-000014
- Allele frequency 0.1 per cent
- Human cfDNA in a recreated plasma matrix
- For determining the limit of detection of digital PCR and NGS assays
- Also serves as a control on extraction efficiency
EGFR-Multiplex 0.1% AF cfDNA in Plasma is a positive standard for EGFR testing on cell-free DNA, at the allele frequency where an assay either performs or does not.
Why the allele frequency matters
In non-small cell lung cancer the EGFR genotype decides the treatment, and the distinction between mutations that respond to tyrosine kinase inhibitors and mutations that confer resistance is what the assay has to make. In plasma the mutant fraction is often well below 1 per cent, so a standard at 0.1 per cent is what shows whether a method can still call the variant reliably at that level.
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 EGFR test kits, determination of the limit of detection, and control of extraction efficiency in the complete workflow from plasma to result. For a less demanding level the same panel is available at 1 per cent allele frequency (SID-000016).
EGFR-Multiplex 0.1% AF cfDNA in Plasma
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Frequently paired with this kit
Other assays and instruments lab teams add alongside the EGFR-Multiplex 0.1% AF cfDNA in Plasma.
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