XL TP53/17cen

Deletion Probe

Order Number
D-5103-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
17
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.

Please use the switch to change to the IVDD product.

IVDDIVDRDiscover all IVDR-certified products

Intended Purpose

The XL TP53/17cen probe is a qualitative, non-automated test for the detection of deletions of the TP53 gene region at 17p13 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 lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), myelodysplastic neoplasms (MDS), 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 ALL, AML, CLL and MDS, 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.

Product Description

The XL TP53/17cen probe consists of an orange-labeled probe hybridizing to the TP53 gene region at 17p13 and a green-labeled probe hybridizing to the centromere of chromosome 17.

Need assistance or a quote?

Images

XL TP53/17cen

XL TP53/17cen hybridized to lymphocytes. Two normal interphases are shown.

Need assistance or a quote?

Expected Patterns

Expected Pattern 1

Normal Cell:
Two green (2G) and two orange (2O) signals.

Expected Pattern 2

Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.

Need assistance or a quote?

Downloads

News


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.

IVDR Certification