Idylla™ MSI FFPE Reference Set [CE-IVD]

Commutable FFPE reference material to mimic patient samples

Idylla™ MSI FFPE Reference Set is a qualitative control for the Idylla™ MSI Assay (Biocartis NV).

SKU: SID-000114 Category:

Product Description

Idylla™ MSI FFPE Reference Set is a reference material for seven microsatellite instability (MSI) loci. These biomarkers are tumor-specific, show a high frequency in colorectal cancer and are stable across different ethnicities.

Product Overview

Intended use:

Idylla™ MSI FFPE Reference Set is intended as commutable, qualitative control material for microsatellite instability (MSI) markers in FFPE format based on human cell lines. It consists of MSI FFPE MSI-H control with all MSI markers at a frequency of 1x LOD for the Idylla™ MSI Test (refer to Idylla™ MSI Test package insert) and MSI FFPE MSS control with 0% frequency for all MSI markers. This Reference set enables monitoring of the performance, procedures and workflow of laboratory tests using FFPE in combination with the automatic workflow of the Idylla™ platform (Biocartis NV).

The product is intended to be used only with the Idylla™ MSI Test by professionals.

Loci covered: ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2

Format: FFPE (Formalin Fixed Paraffin Embedded)

1 set contains 2 products:

  1. SID-000116, Idylla™ MSI 0 % FFPE Reference Standard
  2. SID-000117, Idylla™ MSI 16.67 % FFPE Reference Standard

Unit size: 1 curl per vial

Expected DNA yield: ≥ 110 ng (using Qiagen QIAamp DNA FFPE Tissue Kit)

DNA Integrity Number (DIN): ≥ 5

Thickness of one curl/cut: 10 µm

Storage: 2-8 °C

Expiry: stable for 24 months from date of manufacturing (as supplied)


Certificate of Analysis

SID-000114 Idylla™ MSI FFPE Reference Set [CE-IVD]:

Lot: 00416 | 00417 | 00420 | 00421 | 00422

SID-000116 Idylla™ MSI 0 % FFPE Reference Standard:

Lot: 00261 | 00262 | 00263 | 00380

SID-000117 Idylla™ MSI 16.67 % FFPE Reference Standard:

Lot: 00264 | 00265 | 00382 | 00383 | 00384

Instructions for use

Safety Data Sheet (SDS in other languages ​​available on request. Please contact the support.)