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 for in vitro diagnostic medical devices (IVDR).

MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.

Until further notice, we will continue to provide IVDD products in various countries.

As part of our phased rollout, the IVDR-certified probes are now available in Australia, Austria, Bangladesh, Belgium, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Iceland, Italy, Jordan, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Nepal, Netherlands, New Zealand, Oman, Palestine, Poland, Slovakia, Slovenia, South Africa, Switzerland, Ukraine, and United Arab Emirates with the list of countries continuously expanding.

Note: Our IVDR-certified XA probes are now available across all EU countries. For more details, please visit the individual product pages.

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

XL DLEU/LAMP/12cen

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.

Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.

Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.

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

Expected Pattern 5

Aberrant Cell (typical results):
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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