Past event in Netherlands from Mar 19 to Mar 21, 2025
XA AneuScore III
Aneusomy Probe
- Order Number
- D-5613-500-TC
- Package Size
- (2x 50 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 XA 13/18/21 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 13, chromosome 18 and chromosome 21 by fluorescence in situ hybridization (FISH). The products are intended for prenatal testing of pregnancies at risk for copy number variations of chromosomes X and chromosome Y and trisomy 13, trisomy 18 and trisomy 21 on methanol/acetic-acid fixed uncultured amniocytes.
The XA AneuScore III contains different probe mixes provided in separate test vials.
5x XA X/Y/18 (D-5606-100-TC)
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.
5x XA 13/18/21 (D-5607-100-TC)
The XA 13/18/21 enumeration probe consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2, an aqua-labeled probe hybridizing to the MALT1 gene region at 18q21.3 and an orange-labeled probe hybridizing to the DSCR4 gene region at 21q22.1-22.2.
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.
XA AneuScore III hybridized to amniocytes of two different patients. XA 13/18/21 (upper image) shows a normal signal constellation for 13q14 and 21q22, two green and two orange signals, respectively. For the 18q21 locus-specific probe three blue signals are observed. XA X/Y/18 (lower image) shows a normal signal constellation with one orange (Y centromere-specific), one green (X centromere-specific) and two blue (18 centromere-specific) signals.
For signal patterns please refer to: XA X/Y/18 (D-5606-100-TC) and
XA 13/18/21 (D-5607-100-TC).
Tumour Genetics Symposium 2025
Upcoming Event in Germany from May 8 to May 10, 2025
Meet our colleagues in Leipzig, Germany!
European Cytogenetics Conference
Upcoming Event in Belgium from Jun 29 to Jul 1, 2025
Meet our colleagues in Leuven, Belgium!
