XL IGH BA

Break Apart Probe

Order Number
D-5107-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
14
Regulatory Status
IVDR
Intended Purpose
Product Description
Images
Expected Patterns
Downloads
News

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 IGH BA break-apart probe is a qualitative, non-automated test for the detection of IGH-rearrangements at 14q32.3 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), 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 ALL and 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.

Product Description

The XL IGH BA break-apart probe consists of an orange-labeled probe partly covering the constant region of the IGH locus at 14q32.3 and a green-labeled probe hybridizing to the variable distal region of the IGH locus at 14q32.3.

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Images

XL IGH BA

XL IGH BA hybridized to lymphocytes. Two normal interphases are shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green-orange colocalization/fusion signals (2GO).

Expected Pattern 2

Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.

Expected Pattern 3

Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO) resulting from the loss of one green signal and one orange signal.

Expected Pattern 4

Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one green (1G) signal resulting from the loss of one orange signal.

Expected Pattern 5

Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one orange (1O) signal resulting from the loss of one green signal.

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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