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XL t(14;18) IGH/BCL2 DF

Translocation/Dual Fusion Probe

Order Number
D-5113-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
1418
Regulatory Status
IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.

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Intended Purpose

The XL t(14;18) IGH/BCL2 DF dual-fusion probe is a qualitative, non-automated test for the detection of IGH::BCL2-rearrangements, t(14;18)(q32.3;q21.3) 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 chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for CLL and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.

Product Description

The XL t(14;18) IGH/BCL2 DF dual-fusion probe consists of a green-labeled probe hybridizing to the IGH gene region at 14q32.3 and an orange-labeled probe hybridizing to the BCL2 gene region at 18q21.3.

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Images

XL t(14;18) IGH/BCL2 DF

XL t(14;18) IGH/BCL2 DF hybridized to lymphocytes. One normal interphase and metaphase 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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