EGFR-Multiplex 1% AF cfDNA in Plasma
EGFR-Multiplex 1% AF cfDNA in Plasma (SID-000016) is a reference material for EGFR mutation testing on liquid biopsy, with a mix of TKI-sensitive and TKI-resistant EGFR mutations at an allele frequency of 1 per cent, in human cfDNA in a recreated plasma matrix. One per cent is the level at which most validated liquid biopsy assays are expected to call a variant, which makes this the working standard for routine run control, with the 0.1 per cent material reserved for determining the limit of detection.
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This kit in detail
- TKI-sensitive and TKI-resistant EGFR mutations, catalogue SID-000016
- Allele frequency 1 per cent
- Human cfDNA in a recreated plasma matrix
- As a positive control in routine runs and in assay validation
- The same panel is available at 0.1 per cent (SID-000014)
EGFR-Multiplex 1% AF cfDNA in Plasma is a positive standard for EGFR testing on cell-free DNA at 1 per cent allele frequency.
Application
At 1 per cent a validated liquid biopsy assay should call the variant without difficulty, so this material works as a run control and in the development and validation of EGFR test kits. For establishing the limit of detection, the same panel at 0.1 per cent (SID-000014) is the material to use.
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).
Clinical relevance of the panel
The panel contains both mutations that predict a response to tyrosine kinase inhibitors and mutations that confer resistance to them. That combination is what an EGFR assay for non-small cell lung cancer has to distinguish, since the two lead to opposite treatment decisions.
EGFR-Multiplex 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 1% AF cfDNA in Plasma.
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