The Idylla™ MSI FFPE Reference Set is a high-quality, formalin-fixed paraffin-embedded (FFPE) reference material designed to simulate patient samples in laboratory environments. This product is an essential qualitative control for the Idylla™ MSI Assay (Biocartis NV), focusing on seven key microsatellite instability (MSI) loci. These MSI biomarkers are critical for assessing tumor-specific genetic variations, showing a high prevalence in colorectal cancer, and maintaining stability across diverse populations.

Product Overview

The Idylla™ MSI FFPE Reference Set is intended as a versatile, commutable control for monitoring laboratory workflows involving MSI markers in an FFPE format, derived from human cell lines. It is composed of two components:

1. MSI-H Control: This positive control includes all MSI markers at a frequency equivalent to 1x the limit of detection (LOD) for the Idylla™ MSI Test. This configuration provides robust accuracy for detecting MSI in laboratory testing, matching the exact specifications required by the Idylla™ MSI Test.
2. MSS Control: A negative control featuring an MSI marker frequency of 0%, this control ensures accurate, contamination-free readings across all MSI markers. The Idylla™ MSI FFPE Reference Set aligns seamlessly with the automated workflow of the Idylla™ platform by Biocartis, making it ideal for laboratory professionals aiming to maintain rigorous quality control.

Key Applications

• Qualitative Control for Idylla™ MSI Test: Acts as a reference to monitor the performance of the Idylla™ MSI Test.
• FFPE Testing Workflow: Optimized for laboratory workflows that use FFPE materials in conjunction with Idylla’s automatic testing capabilities.
• Clinical Relevance: Highly relevant for colorectal cancer testing due to its high frequency of MSI loci, including ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2 loci.

Product Specifications

• Format: FFPE (Formalin Fixed Paraffin Embedded)
• Package Contents: 1 curl per vial, with two items per set
  • SID-000116: Idylla™ MSI 0% FFPE Reference Standard
  • SID-000117: Idylla™ MSI 16.67% FFPE Reference Standard
• Expected DNA Yield: ≥ 110 ng (using the Qiagen QIAamp DNA FFPE Tissue Kit)
• DNA Integrity Number (DIN): ≥ 5 for optimal DNA quality
• Curl Thickness: Precisely 10 µm per section

Storage and Stability

This Idylla™ MSI FFPE Reference Set is designed for long-term stability, with a shelf life of up to 24 months from the manufacturing date when stored at 2-8°C. This storage requirement ensures the integrity and reliability of the product over time, making it a dependable tool for laboratory professionals.

Intended Use

This reference set is intended exclusively for use with the Idylla™ MSI Test by trained laboratory professionals. It plays a critical role in validating the accuracy, consistency, and overall quality of results obtained from MSI assays, enhancing reliability in clinical genomics.

The Idylla™ MSI FFPE Reference Set is a valuable tool for clinical genomics, providing consistent, reproducible results, helping professionals monitor and optimize the accuracy of the Idylla™ MSI Assay.