Redefining Reference Standards

HDx™ Reference Standards
Identify and Control Variability Every Day

Genomic DNA

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Identify and Control Variability in your Assay

Genomic DNA is an ideal tool to establish the limit of detection of molecular assays, but to be effective it must be extracted from cell lines with precisely controlled copy numbers and allelic frequencies, which is not easily achievable with patient derived cell lines. HDx™ Reference Standards therefore represent an ideal solution, due to the highly characterized, reproducible nature of the cell lines used to generate the DNA.

Base-Seq HDx™ Reference Standards for Sanger & qPCR Sequencing  

DNA Reference Standards are derived from engineered mutant (50% mutant) and matched “normal” (0% mutant) cell lines. Mutant cell lines are all heterozygotes, and in the majority of cases this means there is a single mutant allele and a single normal allele. Where the copy number is 2N, a 100% mutant DNA sample indicates that 100% of the cells that the DNA was extracted from contained the mutation, however as only one of the two copies of the gene from that cell will actually contain the mutation, the sample will actually have an allelic frequency of 50% for that mutation. Genotypes with a copy number of 3N and with a single mutant allele would have an allelic frequency of 33%. Mutant and “normal” DNA can be precisely blended to generate samples with specific allelic frequencies.

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Operator Variability
Pre-Analytical
Analytical
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Sample FFPE DNA Extraction DNA Quantitfication Platform Sanger QPCR NGS Molecular Assay Output

Sources of variability within a standard molecular assay workflow

Products

  • Horizon Diagnostics provides a range of validated reference standards at 50% allelic frequeny or 0% allelic frequency (wild type), verified by digital PCR. These can be used to generate standard curves covering allelic frequencies 20%, 10%, 5%,1% and/or others. Custom pre-mixed reference standards (e.g. 20%, 10%, 5%, 1%) are available upon request.
  • Routine Validation Packs provide DNA at a sufficient range of allelic frequencies with matched wild-type to enable users to generate a standard curve, with each dilution previously validated by Horizon using digital PCR.  Packs are currently available for BRAF, EGFR and KRAS gene variants.

All DNA Reference Standards are provided at 5ng/µl concentration and in multiples of 100 ng tubes unless otherwise stated.  Custom aliquoting is available upon request.

Key Features

  • Allelic frequency can be modified as required
  • Precisely validated for copy number and allelic frequency using Droplet Digital PCR
  • Use of matched mutant and normal DNA replicates typical tumor genetics
  • HDx Reference Standards are a highly consistent, renewable resource

Applications

  • Routine monitoring of analytical performance, for both specificity and sensitivity
  • Standard curve generation to establish limit of detection
  • Independent assay verification
  • Assay/ platform optimization
  • Staff training

Also available as Formalin-Fixed, Paraffin-Embedded (FFPE) sections.

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