Upcoming 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
- IVDD
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
The XA X/Y/18 mix of specific probes allows detecting copy number variations for chromosomes X, Y, and 18. The probe mix is composed of repetitive sequences which hybridize to the centromeric region of chromosomes X in green, Y in orange, and 18 in blue (aqua).
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.
Numerical aberrations of autosomes 13, 18, 21, and sex chromosomes X and Y account for 95% of birth defects in newborns. FISH applied to uncultured amniocytes provides a method to identify those aberrations much faster than conventional chromosome analysis. It has become a standard to provide preliminary results for the detection of anomalies in less than 12 hours.
Repetitive sequences around the centromeric region of chromosome 18 can reliably determine Edward's syndrome, while chromosome X and Y specifically detect Klinefelter syndrome (47,XXY), Triple-X syndrome (47,XXX), Turner syndrome (45,X0), and 47,XYY.
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.
- Trepperberg et al (2001) Prenat Diagn 21:293-301
- Stumm et al (2006) Cytogenet Genome Res 114:296-301
Package Insert (EN)Package Insert (IT)Performance Data (English)Probes Catalog
Certificate of Analysis (CoA)
or go to CoA DatabaseOur Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Feb 1, 2025: Rollout of IVDR-certified XCyting FISH Probes!
The first phase of this rollout includes the following countries: Austria, Cyprus, Estonia, Germany, Iceland and The Netherlands. More countries will be supplied over time.
