XL 19p/19q del

Deletion Probe

Order Number
D-6019-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
19
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.

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Intended Purpose

The XL 19p/19q del probe is a qualitative, non-automated test for the detection of deletions in the GLTSCR1/GLTSCR2 gene region at 19q13.3 and copy number variations of chromosome 19 by fluorescence in situ hybridization (FISH). A reference probe hybridizes to the ZNF443 gene region at 19p13.2. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected solid tumors (e.g., gliomas), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), myeloproliferative neoplasms (MPN). Hybridization is to be performed on sections of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or on methanol/acetic-acid fixed plasma cells for MM or on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for MPN and CLL.

Product Description

The XL 19p/19q del probe consists of a green-labeled probe hybridizing to the ZNF443 gene region at 19p13.2 and an orange-labeled probe hybridizing to the GLTSCR1/GLTSCR2 gene region at 19q13.3.

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Images

XL 19p/19q del

XL 19p/19q del hybridized to oligodendroglioma tissue. Loss of heterozygosity of 19q is indicated by the loss of one orange signal.

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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.

Expected Pattern 3

Aberrant Cell (typical results):
Three green (3G) and three orange (3O) signals each resulting from a gain of one green signal and one orange signal.

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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