KRAS 5% FFPE Slide Ref Std Tumor QC

Product Overview

Each slide contains precisely sectioned tumor tissue with a validated 5% KRAS mutant allele frequency, providing a ready-to-use tool for monitoring the entire analytical workflow from histopathological review to molecular mutation detection. This product addresses the critical need for standardized QC materials that mimic real clinical specimens, eliminating variability introduced by manual sectioning and enabling consistent performance assessment across assay runs .

Product Features

Precisely Prepared Sections

Each slide contains 15 μm thick sections with a uniform cellular density of approximately 3.5 x 10⁵ cells per section, ensuring consistent DNA input for each assay . The sections are mounted on positively charged glass slides to prevent detachment during staining and extraction procedures.

Multiplex Quality Control Capability

The standard enables simultaneous verification of both histopathological and molecular processes. Pathologists can evaluate tissue morphology and tumor content, while molecular scientists validate nucleic acid extraction efficiency and mutation detection sensitivity—all using the same specimen .

Broad Assay Compatibility

Validated for use with immunohistochemistry (IHC), qPCR, ddPCR, and NGS platforms, the standard supports comprehensive workflow validation. Its DNA maintains integrity through standard FFPE processing, with fragment sizes suitable for both amplicon-based and hybridization-capture NGS methods .

Usage

Histopathological Evaluation

Prior to molecular analysis, stain slides with Hematoxylin and Eosin (H&E) to confirm tissue morphology and estimate tumor cellularity. This step ensures proper alignment between histological assessment and molecular results, a critical factor in clinical sample interpretation.

DNA Extraction Protocol

Deparaffinize slides using xylene substitutes or non-toxic deparaffinization reagents followed by ethanol washes. Perform DNA extraction using column-based or magnetic bead methods, with recommended elution volumes of 50-100 μL to achieve optimal concentration (typically 30-50 ng/μL) .

QC Application

Use the extracted DNA to:

• Validate daily assay performance

• Monitor operator proficiency

• Verify reagent lot consistency

• Calibrate mutation detection thresholds

• Compare results across different testing platforms

FAQ

How many sections are on each slide?

Each slide contains 5-6 consecutive 15 μm sections, providing sufficient material for 2-3 independent extractions or a combination of histological and molecular analyses.

Can this standard be used for IHC validation?

Yes, the preserved protein epitopes in the FFPE sections make this standard suitable for validating KRAS protein expression assays alongside DNA-based mutation test.

What is the shelf life of the slides?

When stored at 4°C in a slide box with desiccant, unopened slides remain stable for 24 months. Once opened, use remaining sections within 1 month to prevent tissue degradation .

How does this product support regulatory compliance?

The standard facilitates compliance with CLIA and CAP requirements for ongoing quality monitoring. Its traceable allelic frequency and comprehensive documentation support audit-ready QC records .

Technical Data