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 22q11 IGL BA
Break Apart Probe
- Order Number
- D-5117-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 2222
- Regulatory Status
- IVDR
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.
The XL 22q11 IGL BA break-apart probe is a qualitative, non-automated test for the detection of IGL-rearrangements at 22q11.2 by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected non-Hodgkin-lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue.
The XL 22q11 IGL BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the IGL gene region at 22q11.2 and a green-labeled probe hybridizing distal to the IGL gene region at 22q11.2.
XL 22q11 IGL BA hybridized to normal lymphocytes. Two normal overlapping interphases are shown. The green and orange probes are flanking the IGVL gene region which is relatively large in size. Thus, the distance between the differently labeled signals in normal cells might appear greater than observed with probes flanking smaller genes.
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.
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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