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 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 large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
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 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.
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 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.
