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Quality Controls & Reference Standards
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PIK3CA-E545G 50% AF FFPE Reference Standard curl

The PIK3CA-E545G 50% AF FFPE Reference Standard curl is a high-quality FFPE reference standard that mimics patient samples and is essential for clinical genomics and molecular diagnostics. Derived from human cell lines, this product is used in diagnostic and R&D labs for assay validation, protocol development, and instrument calibration. This reference curl features 2,287 cancer-relevant mutations across 116 genes, with PIK3CA-E545G mutation at a 50% allelic frequency confirmed via ddPCR. It supports: Reliable DNA/RNA extraction Enhanced control in sequencing and PCR workflows, including WGS and WES Determination of sensitivity limits Routine quality checks for research applications   Each curl yields a minimum of 400 ng of DNA or RNA using the Qiagen AllPrep DNA/RNA FFPE kit, with a curl thickness of 10 µm and a shelf life of up to 24 months at 2-8°C. The PIK3CA-E545G 50% AF FFPE Reference Standard curl provides reliable quality control, enhancing reproducibility in genetic testing.

Reagens SensID Unit size: 1 curl per vial
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Reagens
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SensID
Packaging
Unit size: 1 curl per vial
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Product details

This kit in detail

  • Ensures reliable DNA/RNA extraction in genomics workflows.
  • Provides accurate control for sequencing and PCR protocols.
  • Determines sensitivity limits for diagnostic precision.
  • Enables routine, consistent quality monitoring for research.

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.

PIK3CA-E545G 50% AF FFPE Reference Standard curl

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