The PIK3CA-E545G 50% AF FFPE Reference Standard curl is a formalin-fixed paraffin-embedded (FFPE) reference material derived from human cell lines, specifically designed to replicate patient samples in research and diagnostic settings. This high-quality FFPE standard is an essential workflow control for use in diagnostic laboratories and research and development (R&D) departments, supporting assay validation, FFPE diagnostic kit development, and extraction kit optimization. For details on additional gene mutations, refer to the comprehensive list on the product page.

The PIK3CA-E545G 50% AF FFPE Reference Standard curl is tailored for quality control in clinical genomics workflows and is particularly effective for the following applications:

• Validation of extraction protocols: Ensures reliable DNA and RNA isolation, which is crucial for downstream assays.
• Control in sequencing protocols: Suitable for Whole Genome Sequencing (WGS), Whole Exome Sequencing (WES), amplicon sequencing, and PCR workflows.
• Detection limit determination: Helps labs establish sensitivity limits for accurate detection of low-level mutations.
• Instrument calibration: Assists in calibrating and developing DNA processing workflows, including DNA fragmentation through acoustic shearing, enzymatic digestion, or sonication.
• NGS pipeline performance analysis: Supports accuracy and reliability across next-generation sequencing (NGS) workflows.
• Routine performance monitoring: Facilitates regular quality assessments for research applications (Research Use Only).

Product Overview

• Format: FFPE (Formalin Fixed Paraffin Embedded) standard
• Unit size: 1 curl per vial
• Expected DNA yield: At least 400 ng when using the Qiagen AllPrep DNA/RNA FFPE kit
• Expected RNA yield: At least 400 ng when using the Qiagen AllPrep DNA/RNA FFPE kit
• Curl thickness: Precisely 10 µm per curl

Mutation Profile and Testing

This reference standard includes 2,287 cancer-relevant mutations across 116 genes, offering a comprehensive tool for clinical and research workflows. The specific mutation PIK3CA-E545G (HGVS: c.1634A>G) has been verified using digital droplet PCR (ddPCR) to confirm a 50% allelic frequency, ensuring high accuracy and reproducibility. Orthogonal sequencing further confirms this mutation, adding an extra layer of reliability.

Key Attributes:

• Allelic frequency: PIK3CA-E545G at 50%, verified by ddPCR.
• Storage conditions: Recommended storage at 2-8°C.
• Shelf life: Stable for 24 months from the manufacturing date.

The PIK3CA-E545G 50% AF FFPE Reference Standard curl is a valuable tool for improving the consistency, reliability, and reproducibility of results in genetic testing, making it indispensable for clinical genomics and molecular diagnostics.