Products - MOLECULAR DIAGNOSTIC

REALQUALITY RQ-BCR-ABL p190 One-Step

 

Description

REALQUALITY RQ-BCR-ABL p190 One-Step is a CE-IVD kit for the identification and quantification of the translocation t(9;22) (q34;q11), in the variant p190 (m-bcr e1a2 transcript), which involves the ABL proto-oncogene on chromosome 9 and part of the BCR gene on chromosome 22, by one-step Real-time RT-PCR of the BCR-ABL fusion gene.

Peculiarity

  • The device was developed in accordance with the Europe Against Cancer (EAC) guidelines
  • The device is validated on RNA extracted from leukocyte pellet
  • 5 µL of extracted RNA/reaction are sufficient for the assay to be performed
  • It is equipped with a dUTP/UNG system for the prevention of carry-over contamination and a fluorescence normalizer
  • With the use of quantified standards (REALQUALITY RQ-BCR-ABL p190 STANDARD), the assay is quantitative and usable for monitoring the Minimum Residual Disease (MRD)
  • Real time reverse transcription and amplification take place in a single step (Real-Time RT-PCR)
  • The assay shares the same thermal profile as the REALQUALITY RQ-BCR-ABL p210 One-Step kit
  • It is validated on the most common Applied Biosystems Real-Time PCR thermocyclers

 

Kit content

  • Ready-to-use reagents for Real time amplification
  • Positive control (DNA containing part of the sequence BCR-ABL p190 and ABL)
 
 
For further information
 
The chromosomal rearrangement, known as the Philadelphia (Ph) chromosome, was the first clonal marker identified in a neoplastic disease.
The Ph chromosome derives from the translocation t(9;22)(q34;q11) and is a marker present in more than 95% of the cases of Chronic Myeloid Leukemia (CML), found in about 5% of cases of Acute Lymphoblastic Leukemia (ALL) in children and in 10 - 25% of cases of ALL in adults, where it represents a negative prognostic factor, both in adults and in children.
At the molecular level the translocation juxtaposes the protoncogene ABL (cABL), normally located on chromosome 9, to a specific region of the BCR gene; the break point on chromosome 9 is located within exon 2 of the ABL gene, while the break point on chromosome 22 is located in different positions within the BCR gene, giving rise to different fusion transcripts.
 
The most frequent breakpoint in the BCR gene lies within a region called the "major breakpoint cluster region M-bcr" and produces the BCR-ABL p210 fusion gene.
A second breakpoint within the BCR gene has been identified almost exclusively in the Ph+ ALL. In fact, in about 60% of ALL Ph+, the break point in BCR is located in a region called "minor breakpoint cluster region m-bcr". The result is the juxtaposition of exon e1 of the BCR gene with exon a2 of the ABL gene (e1-a2 rearrangement). The BCR-ABL m-bcr fusion gene is transcribed into a hybrid mRNA, translated into a 190 kDa fusion protein (p190 BCR-ABL).
 
Why use Real time PCR assay for BCR-ABL p210?
 
The identification of this fusion gene provides useful information for the diagnosis and prognosis of these types of leukemias.
 

 

Files to download:

Ordering Information

Code Description Package
RQ-115-4M REALQUALITY RQ-BCR-ABL p190 One-Step 50 test
RQ-115-6M REALQUALITY RQ-BCR-ABL p190 One-Step 100 test