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XL t(15;17) DF
Translocation/Dual Fusion Probe
- Order Number
- D-5086-100-OG
- Package Size
- 100 µl (10 Tests)
- 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.
The XL t(15;17) DF dual-fusion probe is a qualitative, non-automated test for the detection of PML::RARA-rearrangements, t(15;17)(q24;q21.2) 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 promyelocytic leukemia (APL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL t(15;17) DF dual-fusion probe consists of an orange-labeled probe hybridizing to the PML gene region at 15q24 and a green-labeled probe hybridizing to the RARA gene region at 17q21.1-21.2.
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.
XL t(15;17) DF hybridized to bone marrow cells. One orange, one green, and two fusion signals each are observed in the interphase nuclei indicating the presence of t(15;17).
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.
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