Products - MOLECULAR DIAGNOSTIC

REALQUALITY RQ-BCR-ABL p210 One-Step

 

Description

REALQUALITY RQ-BCR-ABL p210 One-Step is a CE-IVD kit for the identification and quantification of the t(9;22) (q34;q11) translocation, in the variant p210 (M-bcr b3a2 and b2a2 transcripts) , 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 and validated using the "Raccomandazioni e Indicazioni Laboratoristiche" of the LabNet network.
  • 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 calibrated with reference material IRMM ERM-AD623 BCR-ABL1 (REALQUALITY RQ-BCR-ABL p210 STANDARD), the assay is quantitative and usable for monitoring the Minimum Residual Disease (MRD)
  • With the use of known concentration reference RNA (BCR-ABL p210 REFERENCE) allows to calculate the Conversion Factor (FC) of the lab, it is necessary to convert the final results of the analysis into Internationale Scale (IS) value
  • 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 p190 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 p210 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 breakpoint in the BCR gene lies within a region called the "major breakpoint cluster region M-bcr". This region is located between exon 12 and 16 (also known as exon b1-b5). Most frequently breakpoints are found in exons b2 and b3 of the BCR gene and in exons a2 and a3 of the ABL gene, producing the BCR-ABL p210 fusion gene. The BCR-ABL p210 fusion gene gives rise to a fusion protein of 210 kDa (BCR ABL p210), which displays transforming activity, stimulating uncontrolled cell proliferation
 
Why use a Real-Time RT-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 but also provides the means for monitoring the Minimal Residual Disease (MRD) in patients pharmacologically treated, with consequent effects on the therapy. 
 
 

 

 

 
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Ordering Information

Code Description Package
RQ-105-4M REALQUALITY RQ-BCR-ABL p210 One-Step 50 test
RQ-105-6M REALQUALITY RQ-BCR-ABL p210 One-Step 100 test