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.
XL 2p11 IGK BA
Break Apart Probe
- Order Number
- D-5116-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 022
- 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.
XL 2p11 IGK BA probe consists of an orange-labeled probe hybridizing to the ´IGKV distal´ region at 2p11.2, and a green-labeled probe hybridizing distal to the ´IGKV proximal´, IGKJ and IGKC region at 2p11.2.
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.
Clinical Applications
- Non-Hodgkin Lymphomas (NHL)
XL 2p11 IGK BA hybridized to lymphocytes. Two normal interphases are shown. The orange signals might appear as paired dots in normal cells.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.
- Martin-Subero et al (2002) Int J Cancer 98:470-474
- Einerson et al (2006) Leukemia 10:1790-1799
- Fujimoto et al (2008) Eur J Haematol 80:143-150
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.
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