XL TCL1 BA

Break Apart Probe

Order Number
D-5142-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
14
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 TCL1 BA break-apart probe is a qualitative, non-automated test for the detection of TCL1A/TCL1B-rearrangements at 14q32.1-32.2 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 T-cell prolymphocytic leukemia (T-PLL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL TCL1 BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the TCL1A/TCL1B gene region at 14q32.1 and a green-labeled probe hybridizing distal to the TCL1A/TCL1B gene region at 14q32.1-14q32.2.

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Images

XL TCL1 BA

XL TCL1 BA hybridized to lymphocytes. One aberrant interphase nucleus with one fusion signal, and one separate orange and green signal is shown, representing a rearrangement with involvement of the TCL1 gene cluster.

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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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