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 RB1/DLEU/
LAMP
Deletion Probe
- Order Number
- D-5070-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1313
- 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 RB1/DLEU/LAMP probe is a qualitative, non-automated test for the detection of deletions of the RB1 gene region at 13q14.2 and the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 by fluorescence in situ hybridization (FISH). The LAMP1 gene region at 13q34 is included as a reference. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin-lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for CLL, on methanol/acetic-acid fixed plasma cells for MM and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL RB1/DLEU/LAMP probe consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2, an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and an aqua-labeled probe hybridizing to the LAMP1 gene region at 13q34.
XL RB1/DLEU/LAMP hybridized to lymphocytes. Two normal interphases are shown.
Normal Cell:
Two Blue (2B), two green (2G) and two orange (2O) signals.
Aberrant Cell:
Two blue (2B), two green (2G) and one orange (1O) signal resulting from the loss of one orange signal.
Aberrant Cell:
Two blue (2B), one green (1G) and one orange (1O) signal resulting from the loss of one green and one orange signal.
Aberrant Cell:
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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