Past event in Netherlands from Mar 19 to Mar 21, 2025
XA AneuScore I
Aneusomy Probe
- Order Number
- D-5604-100-TC
- Package Size
- (2x 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 13/21 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 13 and chromosome 21 by fluorescence in situ hybridization (FISH). 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 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 I contains different probe mixes provided in separate test vials.
XA 13/21 (D-5602-100-OG)
The XA 13/21 enumeration probe consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2 and an orange-labeled probe hybridizing to the DSCR4 gene region at 21q22.1-22.2.
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.
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 I probe kit hybridized to normal lymphocytes. XA X/Y/18 (up) shows signals at the centromeric regions of the X chromosme in green, the Y chromosme in orange, and chromosme 18 in blue. The XA 13/21 (down) shows orange signals at 21q22 and green signals at 13q14.
For signal patterns please refer to: XA 13/21 (D-5602-100-OG) and XA X/Y/18 (D-5606-100-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!
