XL t(8;21) plus

Translocation/Dual Fusion Probe

Order Number
D-5114-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
821
Regulatory Status
IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).

MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.

Please use the switch to change to the IVDD product.

IVDDIVDRDiscover all IVDR-certified productsDownload Instructions For Use (IFU)

Until further notice, we will continue to provide IVDD products in various countries.

As part of our phased rollout, the IVDR-certified probes are now available in Austria, Cyprus, Estonia, Germany, Iceland, and the Netherlands, with the list of countries continuously expanding.

Intended Purpose

The XL t(8;21) plus dual-fusion probe is a qualitative, non-automated test for the detection of RUNX1::RUNX1T1-rearrangements, t(8;21)(q21.3;q22.1) by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute myeloid leukemia (AML). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

XL t(8;21) plus

The XL t(8;21) plus dual-fusion probe consists of a green-labeled probe hybridizing to the RUNX1T1 gene region at 8q21.3-22.1 and an orange-labeled probe hybridizing to the RUNX1 gene region at 21q22.1.

Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.

Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.

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Images

XL t(8;21) plus

XL t(8;21) plus hybridized to lymphocytes. One normal metaphase and one normal interphase are shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green (2G) and two orange (2O) signals.

Expected Pattern 2

Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the relevant loci.

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Downloads

Performance Data (English)Probes Catalog

Certificate of Analysis (CoA)

or go to CoA Database

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