XL MLL plus

Break Apart Probe

Order Number
D-5060-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
11
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 MLL plus break-apart probe is a qualitative, non-automated test for the detection of KMT2A-rearrangements at 11q23.3 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 acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL MLL plus break-apart probe consists of an orange-labeled probe hybridizing proximal to the KMT2A gene region at 11q23.3 and a green-labeled probe hybridizing distal to the KMT2A gene region at 11q23.3.

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Images

XL MLL plus

XL MLL plus hybridized to bone marrow cells. Two aberrant interphase nuclei with one fusion signal and one separate orange and green signal each are shown, representing a translocation with KTM2A involvement.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green-orange colocalization/fusion signals (2GO).

Expected Pattern 2

Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.

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