PIK3CA-E542K 100% AF FFPE Reference Standard Curl

The PIK3CA-E542K 100% AF FFPE Reference Standard Curl is a commutable control that mimics patient samples and is ideal for use in diagnostic and research workflows. This product is derived from a human cell line and is formalin-fixed paraffin-embedded (FFPE), making it an essential tool for various laboratory applications.

This FFPE reference material serves as a comprehensive workflow control for diagnostic assays, research and development (R&D), and validation of FFPE diagnostic and extraction kits. It provides reliable mutation status information for a variety of genes, which can be accessed on this product’s page. Specifically, it’s a perfect fit for clinical genomics workflows, including the validation and development of extraction protocols, sequencing protocols (such as Whole Genome Sequencing (WGS), Whole Exome Sequencing (WES), Amplicon Sequencing), and PCR protocols.

In addition, this reference standard is crucial for determining the detection limits of diagnostic methods, as well as for calibrating and developing DNA processing instruments and workflows (e.g., DNA fragmentation via acoustic shearing, enzymatic digestion, or sonication). It also allows for the performance evaluation of Next-Generation Sequencing (NGS) pipelines and is valuable for routine performance monitoring in research (Research Use Only).

Product Overview

• Format: FFPE (Formalin-Fixed Paraffin Embedded)
• Unit size: 1 curl per vial
• Expected DNA yield: ≥ 400 ng (using the Qiagen AllPrep DNA/RNA FFPE kit)
• Expected RNA yield: ≥ 400 ng (using the Qiagen AllPrep DNA/RNA FFPE kit)
• Thickness of one curl/cut: 10 µm
• Mutations: Contains 48 cancer-relevant mutations across 42 genes.
• Mutation Status: Specifically tested for PIK3CA-E542K (HGVS: c.1624G>A) using ddPCR for precise allelic frequency determination.
• Allelic Frequency: PIK3CA-E542K = 100%
• Storage Conditions: 2-8 °C
• Expiry: Stable for 24 months from the manufacturing date (when supplied).

Quality Control Details

• DNA Quality Control:
  • Allelic Frequency: Metrologically traceable using ddPCR (Bio-Rad)
  • DNA Quantification: Fluorometric dsDNA measurement (Qubit)
  • DNA Integrity: Verified by agarose gel electrophoresis
• RNA Quality Control:
  • RNA Quantification: Fluorometric RNA measurement (Qubit)

This high-quality PIK3CA-E542K 100% AF FFPE Reference Standard Curl ensures reproducible and reliable results for genomic applications in both diagnostic and research settings.