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.
24XCyte
Human Multicolor FISH Probe
- Order Number
- D-0125-060-DI
- Package Size
- (6 Tests)
- Labels
- multicolor
- Chromosome
- AllAll
- Regulatory Status
- RUO
IVDR Certification
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
24 painting probes specific for the 24 different human chromosomes, labeled with different fluorochromes. The excitation/emission spectra are comparable to the common aqua, green, orange, red and near infrared fluorochromes.
Also available as 120µl (2x60µl) D-0125-120-DI and as 600µl (10x60µl) D-0125-600-DI.
The principle of mFISH is based on combinatorial labeling of whole chromosome paints. For each chromosome, the different fluorochromes are mixed resulting in a unique color combination (see labeling scheme). The analysis is carried out after capturing grey scale images of each fluorochrome. For best separation of the different colors the filter sets used need to be highly selective assuring that crosstalk is reduced to a minimum. Multicolor FISH Analysis with MetaSystems‘ Isis supports the analysis by applying appropriate algorithms which leads to pseudo coloring of the different chromosome classes (color combinations). Each chromosome class will be displayed in a unique color. Translocations show up as color changes on individual chromosomes.
Please note that this product is not classified as an IVD product in the EU according to the REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. It is marked as for ´Research Use Only´ (RUO).
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.
24XCyte hybridized to lymphocytes. Multiple translocations can be identified by conjunction of differently labeled chromosomal fragments.
- Speicher MR et al (1996) Nat Genet 12:368-375
- Fauth C and Speicher MR (2001) Cytogenet Cell Genet 93:1-10
- Schoch C et al (2002) Genes Chromosomes Cancer 35:20-29
IVDR 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.
