Past event in Netherlands from Mar 19 to Mar 21, 2025
XA X/Y/18
Aneusomy Probe
- Order Number
- D-5606-100-TC
- 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 Australia, Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Iceland, Italy, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, New Zealand, Poland, Slovakia, Slovenia, South Africa, and Switzerland, with the list of countries continuously expanding.
The XA X/Y/18 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome X, chromosome Y and chromosome 18 by fluorescence in situ hybridization (FISH). The product is intended for prenatal testing of pregnancies at risk for copy number variations of chromosomes X and chromosome Y and trisomy 18 on methanol/acetic-acid fixed uncultured amniocytes.
The XA X/Y/18 enumeration probe consists of a green-labeled probe hybridizing to the centromere of the X-chromosome, an orange-labeled probe hybridizing to the centromere of the Y-chromosome and an aqua-labeled probe hybridizing to the centromere of the chromosome 18.
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.
XA X/Y/18 hybridized to normal uncultured amniocytes. A normal signal constellation with 1 orange (Y centromere-specific), 1 green (X centromere-specific) and 2 blue (18 centromere-specific) is observed.
Normal Cell (male):
One green (1G), one orange (1O), and two blue (2B) signals.
Normal Cell (female):
Two green (2G) and two blue (2B) signals.
Aberrant Cell (male):
One green (1G), one orange (1O), and three blue (3B) signals.
Aberrant Cell (female):
Two green (2G) and three blue (3B) signals.
Aberrant Cell (male):
Two green (2G), one orange (1O) and, two blue (2B) signals.
Aberrant Cell (female):
One green (1G) and two blue (2B) signals.
Tumour Genetics Symposium 2025
Upcoming Event in Germany from May 8 to May 10, 2025
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