The PIK3CA-H1047R & -D350N 50% AF FFPE Reference Standard curl is a human cell line-derived formalin-fixed paraffin-embedded (FFPE) reference standard, specially designed to replicate patient samples in diagnostic and research environments. This high-quality product is ideal as a full workflow control in diagnostic laboratories and R&D settings, supporting the validation and development of FFPE-based diagnostic assays and extraction kits. For more details on mutation statuses, see the additional gene information on the product page.

Perfectly suited for quality control in clinical genomics workflows, the PIK3CA-H1047R & -D350N 50% AF FFPE Reference Standard curl is instrumental in the following applications:

• Extraction protocol validation and development: Optimizes DNA and RNA isolation protocols for accuracy and consistency.
• Sequencing protocol quality control: Suitable for Whole Genome Sequencing (WGS), Whole Exome Sequencing (WES), amplicon sequencing, and PCR protocols.
• Detection limit determination: Helps laboratories establish the sensitivity thresholds of various methods.
• Instrument calibration: Aids in the precise calibration and development of DNA processing workflows, such as DNA fragmentation via acoustic shearing, enzymatic digestion, or sonication.
• NGS pipeline performance analysis: Ensures the accuracy, reliability, and reproducibility of next-generation sequencing (NGS) workflows.
• Routine monitoring for research: Supports routine accuracy checks in 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 with Qiagen AllPrep DNA/RNA FFPE kit
• Expected RNA yield: At least 400 ng with Qiagen AllPrep DNA/RNA FFPE kit
• Curl thickness: Each curl measures precisely 10 µm thick

Mutation Profile and Testing

This reference standard includes 62 cancer-relevant mutations across 57 genes, with the full mutation list available under the “Additional Genes Covered” tab on the product page. Specific mutations tested include PIK3CA-H1047R (HGVS: c.3140A>G) and PIK3CA-D350N (HGVS: c.1048G>A), each verified using digital droplet PCR (ddPCR) to confirm a precise 50% allelic frequency. This rigorous testing provides reliable and consistent results across workflows where reproducibility is critical.

Key Attributes:

• Allelic frequencies: PIK3CA-H1047R at 50% (measured via ddPCR) and PIK3CA-D350N at 50% (confirmed in sequencing report).
• Storage conditions: Recommended storage at 2-8°C.
• Stability: Stable for up to 24 months from the date of manufacture.

The PIK3CA-H1047R & -D350N 50% AF FFPE Reference Standard curl is an indispensable tool for clinical genomics, helping laboratories optimize FFPE-based workflows, calibrate instruments, determine sensitivity limits, and maintain consistent quality control across genetic testing applications.