XL 6q21/6q23

Deletion Probe

Order Number
D-5039-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
6
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 6q21/6q23 probe is a qualitative, non-automated test for the detection of deletions of the SEC63 gene region at 6q21 and the MYB gene region at 6q23 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), chronic lymphocytic leukemia (CLL), non-Hodgkin-lymphomas (NHL) and T-/NK-large granular lymphocytic leukemia (T-/NK-LGL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for ALL, CLL and T-/NK-LGL and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.

Product Description

XL 6q21/6q23

The XL 6q21/6q23 probe consists of a green-labeled probe hybridizing to the SEC63 gene region at 6q21 and an orange-labeled probe hybridizing to the MYB gene region at 6q23.3.

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 6q21/6q23

XL 6q21/6q23 hybridized to lymphocytes. One normal interphase and metaphase are shown.

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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 3

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

Expected Pattern 4

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

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