XL del(20q) plus

Deletion Probe

Order Number
D-5119-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
20
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 del(20q) plus probe is a qualitative, non-automated test for the detection of deletions of the PTPRT gene region in 20q12 and the MYBL2 gene region at 20q13.1 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 myeloid leukemia (AML), myelodysplastic neoplasms (MDS), myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and myeloproliferative neoplasms (MPN). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

XL del(20q) plus

The XL del(20q) plus probe consists of an orange-labeled probe hybridizing to the PTPRT gene region at 20q12 and a green-labeled probe hybridizing to the MYBL2 gene region at 20q13.1.

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 del(20q) plus

XL del(20q) plus hybridized to lymphocytes. One normal interphase is 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) signals 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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