1. Intended Use
Leukemia BCR-ABL Fusion Gene real time RT-PCR Kit is used for the detection of Leukemia
BCR-ABL Fusion Gene（M-BCR, m-BCR, and μ-BCR） in leukocyte by using real time PCR systems.
2. Product Description
The BCR-ABL fusion gene is associated with formation of the Philadelphia chromosome (Ph) and is
one of the most common genetic abnormalities detected in leukaemia’s. In the vast majority of patients,
the breakpoints in the BCR gene are clustered within three well defined regions. One fusion involves
breaks within the major breakpoint cluster region (M-BCR) of BCR, which includes introns 13 and 14,
and leads to the production of an 8.5 kb transcript coding for a 210 kDa protein (p210). In CML, most
translocations involve the M-BCR of BCR. Leukemia BCR-ABL Fusion Gene real time RT-PCR kit
contains a specific ready-to-use system for the detection of the Leukemia BCR-ABL Fusion Gene
using RT-PCR (Reverse Transcription Polymerase Chain Reaction) in the real-time PCR system. The
master contains three Super Mixes for the specific amplification of M-BCR, m-BCR and m-BCR. The
reaction is done in one step real time RT-PCR. The first step is a reverse transcription (RT), during
which the Leukemia BCR-ABL Fusion Gene (M-BCR，m-BCR, μ-BCR) is transcribed into cDNA.
Afterwards, a thermostable DNA polymerase is used to amplify the specific gene fragments by means
of PCR (polymerase chain reaction). Fluorescence is emitted and measured by the real time systems
optical unit during the PCR. The detection of amplified BCR-ABL fragment is performed in
fluorimeter channel FAM with the fluorescent quencher BHQ1. An external positive control
(1×108copies/ml) supplied, allows the determination of the gene load. For further information, please
refer to section 9.2 Quantitation.