Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XA AneuScore II
Aneusomy Probe
- Order Number
- D-5609-500-TC
- Package Size
- (2x 50 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 AneuScore II Probe Kit contains different probe mix, provided in separate test vials, for assessing chromosomal aneuploidies for chromosomes 13, 18, 21, X, and Y.
XA 13/18/21 (D-5607-100-TC):
The XA 13/18/21 mix of specific probes allows detecting copy number variations of chromosomes 13, 18, and 21. The green labeled probe hybridizes to a region at 13q14 including the RB1 locus, the blue (aqua) labeled probe hybridizes to a locus at 18q21, and the orange labeled probe hybridizes to a region at 21q22 including the DSCR4 (Down syndrome critical region 4).
XA X/Y (D-5608-100-OG):
The XA X/Y mix of specific probes allows detecting copy number variations for chromosomes X and Y. The probe mix is composed of repetitive sequences which hybridize to the centromeric region of chromosomes X in green and Y in orange.
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 considerably faster than conventional chromosome analysis. Nowadays, it is widely accepted to provide preliminary results for the detection of anomalies in less than 12 hours.
Available in two package sizes:
D-5609-100-TC XA AneuScore II, 10 Tests
D-5609-500-TC XA AneuScore II, 50 Tests
XA 13/18/21 and XA X/Y hybridized to uncultured amniocytes. One interphase and one metaphase are shown for each probe mix.
For signal patterns please refer to: XA 13/18/21 (D-5607-100-TC) and XA X/Y (D-5608-100-OG).
- Bryndorf et al (1996) Am J Hum Genet 59:918-926
- Tepperberg et al (2001) Prenat Diagn 21:293-301
- Stumm et al (2006) Cytogenet Genome Res 114:296-301
Package Insert (EN)Package Insert (IT)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.
