FFPE KRAS 5% Section Ref Std for Mutation

Product Overview

This product delivers pre-prepared, 5 μm of KRAS-mutated tumor tissue with a precisely defined 5% mutant allele frequency, representing the challenging yet clinically relevant scenario of detecting rare mutations in heterogeneous tumor samples. Unlike whole-block standards, these individual sections enable researchers to mimic the exact pre-analytical conditions of clinical sample processing, from sectioning to mutation analysis .

Product Features

Ultrathin Section Design

The 5 μm sections replicate the typical thickness used in clinical histopathology, ensuring accurate simulation of DNA extraction efficiency from real patient samples. This design is particularly valuable for optimizing protocols that address FFPE-specific challenges like nucleic acid cross-linking and fragmentation .

Verified Mutation Spectrum

Each section contains a characterized mixture of KRAS-mutated and wild-type cells, with mutations including G12C, G12D, and G12V variants—mutations frequently observed in colorectal, lung, and pancreatic cancers. Allelic frequencies are verified by both ddPCR and NGS, ensuring accuracy within ±30% of the nominal 5% value .

Process Control Capability

The standard includes built-in markers for monitoring pre-analytical variables such as DNA degradation and PCR inhibition, enabling laboratories to identify workflow inefficiencies that may compromise mutation detection sensitivity .

Usage

Optimal Section Handling

Store sections at 4°C until use and avoid prolonged exposure to ambient conditions. Use sterile forceps to transfer sections to extraction tubes to prevent contamination and preserve DNA integrity.

Extraction Optimization

Process sections using your laboratory’s standard FFPE DNA extraction protocol, with modifications as needed to maximize recovery from low-input material. We recommend using extraction kits specifically formulated for FFPE samples to address cross-linking issues .

Assay Sensitivity Testing

Utilize the standard to:

• Determine the limit of detection for KRAS mutations in FFPE specimens

• Validate assay performance across different operator shifts

• Compare extraction efficiency of various commercial kits

• Optimize NGS library preparation for low-input FFPE DNA

FAQ

What is the DNA yield per section?

Each 5 μm section typically yields 100-200 ng of DNA when using optimized extraction protocols, which is sufficient for 2-3 qPCR reactions or a single NGS library preparation .

Can this standard be used to validate digital PCR assays?

Absolutely. The precisely calibrated 5% allelic frequency makes it ideal for validating ddPCR workflows, including determining assay precision, linearity, and bias across the clinically relevant range .

How does this product support NGS panel validation?

The standard’s known mutation profile allows laboratories to verify that their NGS panels can reliably detect low-frequency KRAS mutations amidst wild-type background, a critical performance characteristic for oncology testing .

Are negative control sections available?

Yes, each lot includes companion wild-type KRAS FFPE sections to enable parallel assessment of assay specificity and background noise levels.

Technical Data