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 6q21/6q23/
6cen
Deletion Probe
- Order Number
- D-5088-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 066
- 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 6q21/6q23/6cen probe is a qualitative, non-automated test for the detection of deletions of the SEC63 gene region at 6q21 and the MYB gene region at 6q23 by fluorescence in situ hybridization (FISH). A centromere 6 specific reference is included. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), non-Hodgkin-lymphomas (NHL) and T-/NK-large granular lymphocytic leukemia (T-/NK-LGL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for ALL, CLL and T-/NK-LGL and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL 6q21/6q23/6cen probe consists of a green-labeled probe hybridizing to the SEC63 gene region at 6q21, an orange-labeled probe hybridizing to the MYB gene region at 6q23.3 and an aqua-labeled probe hybridizing to the centromere of chromosome 6.
XL 6q21/6q23/6cen hybridized to lymphocytes. Two normal interphases are shown.
Normal Cell:
Two green (2G), two orange (2O), and two blue (2B) signals.
Aberrant Cell (typical results):
Two blue (2B), one green (1G) and one orange (1O) signal resulting from the loss of one green and one orange signal.
Aberrant Cell (typical results):
Two blue (2B), two green (2G) and one orange (1O) signal resulting from the loss of one orange signal.
Aberrant Cell (typical results):
Two blue (2B), one green (1G) and two orange (2O) signals resulting from the loss of one green signal.
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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