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 20q12/20qter/8cen plus
Deletion/Isochromosome/Enumeration Probe
- Order Number
- D-5122-100-TC
- Package Size
- 100 µl (10 Tests)
- 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 20q12/20qter/8cen plus probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 8, deletions of the PTPRT gene region at 20q12 and isoderivative chromosomes 20q 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 acute myeloid leukemia (AML), myelodysplastic neoplasms (MDS), myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and myeloproliferative neoplasms (MPN). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL 20q12/20qter/8cen plus probe consists of an aqua-labeled probe hybridizing to the centromere of chromosome 8, an orange-labeled probe hybridizing to the PTPRT gene region at 20q12 and a green-labeled probe hybridizing to a region at 20q13.3.
XL 20q12/20qter/8cen plus hybridized to lymphocytes. One normal interphase is shown.
Normal Cell:
Two blue (2B), two green (2G), and two orange (2O) signals.
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):
Three blue (3B), two green (2G) and one orange (1O) signal resulting from loss of one orange signal and a
gain of the blue labeled chromosome.
Aberrant Cell (typical results):
Two blue (2B), three green (3G), and one orange (1O) signal resulting from the presence of ider(20q).
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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