MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
XA TriScore (X/Y/21)
Aneusomy Probe
- Order Number
- D-5603-100-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 large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
The XA TriScore (X/Y/21) mix of specific probes allows detecting copy number variations for chromosomes X, Y, and 21. The probe mix is composed of repetitive sequences which hybridize to the centromeric region of chromosomes X in blue (aqua) and Y in green. The orange labeled probe hybridizes to a region at 21q22 including the DSCR4 (Down syndrome critical region 4).
Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.
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.
Duplications of chromosome bands 21q22.13-q22.2 have been shown to define the smallest region implicated in the causation of Down syndrome. Repetitive sequences around the centromeric region of the X and Y chromosomes can reliably determine Klinefelter syndrome (47,XXY), Triple-X syndrome (47,XXX), Turner syndrome (45,X0), and 47,XYY. This probe also allows to differentiate male fetal cells from maternal cells in blood contaminated amniocyte samples.
XA TriScore (X/Y/21) hybridized to lymphocytes. Two aberrant interphases (47,XY,+21) are shown.
Normal Cell (male):
One green (1G), two orange (2O), and one blue (1B) signal.
Normal Cell (female):
No green (0G), two orange (2O), and two blue (2B) signals.
Aberrant Cell (male):
One green (1G), three orange (3O), and one blue (1B) signal.
Aberrant Cell (female):
No green (0G), three orange (3O), and two blue (2B) signals.
- 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)Performance Data (English)Probes Catalog
Certificate of Analysis (CoA)
or go to CoA DatabaseIVDR Certification
MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.
Over 50 XCyting FISH Probes are IVDR-Certified!
The IVDR is effective and our probes stay the same! A large segment of our portfolio is already IVDR-certified. Our priority is to give you a smooth transition into the IVDR era.
