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 5q31/5q33/
5p15
Deletion Probe
- Order Number
- D-5081-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 055
- 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 5q31/5q33/5p15 probe is a qualitative, non-automated test for the detection of deletions of the EGR1 gene region at 5q31.2 and the RPS14 gene region at 5q32-33.1 by fluorescence in situ hybridization (FISH). A reference at 5p15.2-15.3 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 myeloid leukemia (AML) and myelodysplastic neoplasms (MDS). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL 5q31/5q33/5p15 probe consists of an aqua-labeled probe hybridizing to a region at 5p15.2-15.3, an orange-labeled probe hybridizing to the EGR1 gene region at 5q31.2 and a green-labeled probe hybridizing to the RPS14 gene region at 5q32-33.1.
XL 5q31/5q33/5p15 hybridized to lymphocytes. One normal metaphase is 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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