The PIK3CA-E542K 50% AF FFPE Reference Standard curl is a human cell line-derived formalin-fixed paraffin-embedded (FFPE) reference material designed to closely replicate patient samples in clinical and research applications. This reference standard is particularly valuable as a full workflow control in diagnostic labs or R&D settings, supporting the validation and development of FFPE-based diagnostic assays or extraction kits. Details on additional gene mutation statuses are available on the product page.

Ideal for enhancing accuracy in clinical genomics workflows, the PIK3CA-E542K 50% AF FFPE Reference Standard curl provides essential quality control for a variety of laboratory processes, including:

• Validation and protocol development: Ideal for refining extraction protocols to ensure reliable DNA/RNA isolation.
• Sequencing protocol control: Optimize whole genome sequencing (WGS), whole exome sequencing (WES), amplicon sequencing, and PCR workflows.
• Detection limit establishment: Determine the sensitivity and detection threshold of various methods.
• Instrument calibration: Develop and calibrate DNA processing workflows, such as DNA fragmentation via acoustic shearing, enzymatic digestion, or sonication.
• NGS pipeline performance analysis: Evaluate and verify the performance and consistency of next-generation sequencing (NGS) processes.
• Routine monitoring: Ensure the accuracy and repeatability of results 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, using the Qiagen AllPrep DNA/RNA FFPE kit
• Expected RNA yield: At least 400 ng, using the Qiagen AllPrep DNA/RNA FFPE kit
• Thickness: Each curl is precisely 10 µm in thickness

Mutations and Testing

This reference standard contains 62 cancer-relevant mutations across 57 genes, with a full mutation list available under the “Additional Genes Covered” tab on the product page. Specifically tested mutations include PIK3CA-H1047R(HGVS: c.3140A>G) and PIK3CA-D350N (HGVS: c.1048G>A), verified with digital droplet PCR (ddPCR) for precise allelic frequency determination. Additionally, this reference curl is representative of a 50% allelic frequency for the PIK3CA-E542K mutation, ensuring consistency in experimental results.

Key Attributes:

• Allelic frequency for PIK3CA mutations: PIK3CA-E542K 50%, validated via ddPCR.
• Storage conditions: Store at 2-8°C.
• Shelf life: Stable for 24 months from manufacturing date.

The PIK3CA-E542K 50% AF FFPE Reference Standard curl delivers robust performance for clinical genomics and diagnostic assay development, providing essential support in refining FFPE-based workflows, calibrating instruments, and maintaining quality control across multiple genetic analysis platforms.