XL DLEU/LAMP/12cen

Deletion/Enumeration Probe

Order Number
D-5055-100-TC
Package Size
100 µl (10 Tests)
Labels
   
Chromosomes
1312
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 DLEU/LAMP/12cen probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 12 and deletions of the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 by fluorescence in situ hybridization (FISH). The LAMP1 gene region at 13q34 is included as a reference. 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 DLEU/LAMP/12cen probe consists of a green-labeled probe hybridizing to the centromere of chromosome 12, an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and an aqua-labeled probe hybridizing to the LAMP1 gene region at 13q34.

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Images

XL DLEU/LAMP/12cen

XL DLEU/LAMP/12cen hybridized to bone marrow cells. Three interphases are shown of which one shows a normal signal pattern of 2 orange, 2 green, and 2 blue signals, one nucleus shows a hemizygous, and a third one a homozygous deletion of DLEU (orange).

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Expected Patterns

Expected Pattern 1

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

Expected Pattern 2

Aberrant Cell:
Two blue (2B) two orange (2O) and three green (3G) signals resulting from a gain of the green labeled chromosome.

Expected Pattern 3

Aberrant Cell:
Two blue (2B), two green (2G) and one orange (1O) signal resulting from loss of one orange signal.

Expected Pattern 5

Aberrant Cell:
Two blue (2B), two green (2G) and no orange (no O) signals resulting from homozygous deletion of the locus covered by the orange probe.

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Downloads

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