The MSI/MSS FFPE Reference Set is a high-quality, formalin-fixed paraffin-embedded (FFPE) reference material designed to simulate patient samples in laboratory environments. This Research Use Only (RUO) reference set targets several critical microsatellite instability (MSI) biomarkers as identified in the NCI, Promega, and Biocartis panels, specifically covering loci with high relevance to MSI testing. These biomarkers, essential in colorectal cancer research, also exhibit high frequency across various cancer types, including gastric and endometrial cancer, and are stable across different ethnic groups.

Microsatellite instability testing serves as a tool for assessing mismatch repair (MMR) gene function. Instability in these repeated DNA regions may indicate potential Lynch syndrome or other tumor-specific genetic variations. In the MSI testing process, the MSI/MSS FFPE Reference Set provides reliable control for monitoring these critical markers.

Product Overview

The MSI/MSS FFPE Reference Set is a commutable and qualitative control material based entirely on human cell lines, with no plasmids or artificial sequences. It consists of two controls:

1. MSI-H Control: A high-frequency MSI control for all MSI markers, aligning with the 1x limit of detection (LOD) across various MSI assay systems.
2. MSS Control: A stable MSS control containing 0% MSI marker frequency, providing a robust standard for comparison in assays.

Both controls in the MSI/MSS FFPE Reference Set enable quality monitoring of laboratory workflows that use FFPE materials in various MSI testing systems, making it suitable for assay validation and routine quality control in clinical research environments.

Features and Technical Specifications

• Cell Line Based: Contains 100% cell line DNA, free from artificial sequences or plasmids.
• ddPCR Quantitation: MSI cell content is accurately quantified using droplet digital PCR (ddPCR), enhancing reliability for quality control.
• ISO 13485 Manufactured: Produced under ISO 13485 conditions to ensure consistent, high-quality material.
• Broad Panel Coverage: The set includes loci from three panels:
  • Biocartis Panel: ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2.
  • NCI Panel: BAT25, BAT26, MONO-27, NR-21, NR-24.
  • Promega Panel: Incorporates the NCI loci plus Penta C, Penta D.

Format and Package Contents

• Format: FFPE (Formalin Fixed Paraffin Embedded)
• Package: Each set includes two vials:
  • SID-000137: MSI 0% FFPE Reference Standard
  • SID-000138: MSI 16.67% FFPE Reference Standard
• Yield: Expected DNA yield is ≥ 110 ng per curl using the Qiagen QIAamp DNA FFPE Tissue Kit.
• DNA Integrity: Each curl achieves a DNA Integrity Number (DIN) of ≥ 5, ensuring optimal DNA quality for testing.
• Thickness: Each curl/cut is precisely 10 µm thick.

Storage and Stability

The MSI/MSS FFPE Reference Set is stable for up to 24 months from manufacturing when stored at 2-8°C. This long shelf-life ensures the product remains reliable for extended use in MSI assay validations and quality control procedures.

Intended Use

Exclusively intended for use by laboratory professionals with MSI testing systems, the MSI/MSS FFPE Reference Setprovides a dependable standard for validating, calibrating, and monitoring MSI assays. Its high commutability with patient samples ensures that laboratory workflows remain precise and consistent across different MSI systems.

The MSI/MSS FFPE Reference Set is an invaluable tool in clinical genomics, providing consistent, reproducible results to help professionals monitor and refine MSI assay workflows effectively.