BCR-ABL Fusion Gene Mutation Detection Kit

[REF] UBP-G00224H

[Specification] 24 tests/kit

[Intended Use]

UltraDx BCR-ABL Fusion Gene Mutation Detection Kit is suitable for in vitro qualitative detection of p190 and p210 isoforms of the BCR-ABL fusion gene in human bone marrow samples to help diagnose leukemia patients. The test results are for clinical reference only and the final diagnosis should be considered in conjunction with other clinical indicators.


Chronic myelogenousleukemia (CML) is a malignant clonal disease of hematopoietic stem cells. More than 95% of CML patients carry the Philadelphia chromosome (Ph) in their blood cells[1]. Predominant pathogenesis of CML is as follows: The BCR-ABL fusion gene is formed by a translocation between the abl proto-oncogene (Abelson murine leukemia viral oncogene homolog 1) on the long arm of chromosome 9 (9q34) and the breakpoint cluster region (BCR) gene on the long arm of chromosome 22 (22q11) [2]; the fusion protein encoded by this gene has tyrosine kinase (TK) activity, and activates its downstream signaling pathways (such as RAS, PI3K, and JAK/STAT) to promote cell division and inhibit cell apoptosis, making cells proliferate malignantly, and thereby causing the occurrence of CML [3-4]. BCR-ABL is one of the important diagnostic indicators of CML. The dynamic change of its transcript level is a reliable indicator for prognostic judgment of leukemia and can be used to predict the recurrence of leukemia after treatment.

[Test Principles]

UltraDx BCR-ABL Fusion Gene Mutation Detection Kit uses real-time PCR combined with fluorescent probes. It contains specific primers and probes targeting p190 and p210 isoforms of the BCR-ABL fusion gene. The probes are labeled with the fluorophore FAM (p190 and p210 isoforms) and the quencher BHQ1. During the amplification process, complete synchronization of PCR product formation and fluorescence signal accumulation is achieved based on the 5’-3’ exonuclease activity of the Taq DNA polymerase, thereby realizing the qualitative detection of novel bunyavirus RNA in bone marrow samples from leukemia patients to help diagnose leukemia patients.

UltraDx BCR-ABL Fusion Gene Mutation Detection Kit contains an internal reference with β-actin as an endogenous target gene, primers, and probes labeled with the fluorophore HEX (VIC) and the quencher BHQ2. Based on amplification status of the target gene in the internal reference, processing of a sample to be tested and the presence or absence of PCR inhibition in the test is monitored to identify any false negative test.

  • Strong Specificity: Non-cross reactivity.
  • Contamination control: dUTP/UNG systems to avoid carry over contamination of PCR products in subsequent amplification reactions.
  • High sensitivity: 1000 copies/mL
  • Internal control system: Prevent false negative results.
[Acceptable Specimens]

Applicable sample type: Bone marrow samples freshly collected from patients.

[Applicable Equipment]

Applied Biosystems™ Real time PCR system 7500, ABI QuantStudio™5 Real-time PCR system, LightCycler® 480 PCR system, Bio-Rad CFX96 real-time PCR instrument. Ultrassay eQ9600 Real Time qPCR System etc.