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XL t(15;17) DF

Translocation/Dual Fusion Probe

Order Number
D-5086-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
1517
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(15;17) DF dual-fusion probe is a qualitative, non-automated test for the detection of PML::RARA-rearrangements, t(15;17)(q24;q21.2) 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 promyelocytic leukemia (APL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL t(15;17) DF dual-fusion probe consists of an orange-labeled probe hybridizing to the PML gene region at 15q24 and a green-labeled probe hybridizing to the RARA gene region at 17q21.1-21.2.

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Images

XL t(15;17) DF

XL t(15;17) DF hybridized to bone marrow cells. One orange, one green, and two fusion signals each are observed in the interphase nuclei indicating the presence of t(15;17).

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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 respective loci.

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Downloads

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