XL DLEU/LAMP

Deletion Probe

Order Number
D-5054-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
13
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.

Please use the switch to change to the IVDD product.

IVDDIVDRDiscover all IVDR-certified productsDownload Instructions For Use (IFU)

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 Austria, Belgium, Croatia, Cyprus, Estonia, France, Germany, Iceland, Italy, Liechtenstein, Luxembourg, Malta, Netherlands, Slovenia, and Switzerland, with the list of countries continuously expanding.

Intended Purpose

The XL DLEU/LAMP probe is a qualitative, non-automated test for the detection of 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), multiple myeloma (MM) 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, on methanol/acetic-acid fixed plasma cells for MM 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

The XL DLEU/LAMP probe consists of an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and a green-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.

Need assistance or a quote?

Images

XL DLEU/LAMP

XL DLEU/LAMP hybridized to lymphocytes. One normal interphase and metaphase are shown.

Need assistance or a quote?

Expected Patterns

Expected Pattern 1

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

Expected Pattern 2

Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.

Expected Pattern 5

Aberrant Cell (typical results):
Two green (2G) and no orange (no O) signal resulting from homozygous deletion of the locus covered by the orange probe.

Need assistance or a quote?

Downloads

News