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MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
Discover all IVDR-certified products
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 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 regions of chromosomes X and Y can reliably identify Klinefelter syndrome (47,XXY), Triple-X syndrome (47,XXX), Turner syndrome (45,X0), and 47,XYY.
XA X/Y was hybridized to normal uncultured amniocytes from a male fetus.
Normal Cell:
46,XX
Two green (2G) signals.
Normal Cell:
46,XY
One green (1G) and one orange (1O) signal.
Aberrant Cell:
45,X0
One green (1G) signal.
Mosaics with 46, XX occur frequently.
Aberrant Cell:
47,XXY
Two green (2G) and one orange (1O) signal.
May exist as mosaic with 46, XY or 46, XX.
Aberrant Cell:
47,XYY
One green (1G) and two orange (2O) signals.
Additional X-Chromosomes are possible (e.g. 48, XXYY; 52, XXXXXXYY).
Certificate of Analysis (CoA)
or go to CoA DatabaseMetaSystems 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.
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.
MetaSystems Probes is pleased to announce the new catalog including new and innovative products and supporting information. A PDF version of the new catalog is available for download here.
