This in vitro diagnostic test allows the detection and quantification of BCR-ABL (Philadelphia Chromosome) and is an auxiliary device for diagnosis and monitoring of clinical syndromes associated with the Philadelphia chromosome (Ph+), such as Chronic Myeloid Leukemia (CML) and Acute Lymphoblastic Leukemia (ALL).
Detecting and identifying this translocation not only provides information useful for diagnosis and prognosis of those types of leukemia, but also allows monitoring Deep Molecular Response (MR), i.e. the absence of neoplastic cells persisting in the patient during the different phases of chemotherapy that are undetectable by cytology methods (e.g. analysis of cell morphology).
If the product REALQUALITY RQ-BCR-ABL p210 One-Step is used in combination with REALQUALITY RQ‑BCR‑ABL p210 STANDARD (code RQ‑54‑ST), it allows quantification of M‑bcr transcripts in the sample and normalization to the expression of the housekeeping gene ABL. To express the results in terms of International Scale (IS), we recommend the use of the kit BCR-ABL p210 REFERENCE (code 05‑64‑06).
- One-Step RT-PCR: reverse transcrition and amplification in a single step
- Fast protocol: about 2 hours
- Amplified regions: ABL and BCR-ABL p210 RNA in separate reactions
- Ready-to-use reagents: two master mixes (ABL and BCR-ABL p210)
- Suitable sample types: RNA extracted from leukocyte pellet
- Internal control: amplification of the housekeeping gene (ABL) for the normalization of results
- Positive control: contains sequences from both BCR-ABL p210 and ABL
- Quantitative analyse: possible with using RQ-BCR-ABL p210 standard
- Analytical specificity: no non-specific binding of primers and probes, no cross-reaction with other translocation products
- Diagnostic specificity: 100%
- Diagnostic sensitivity: 98%
- Accuracy: 99%
BCR-ABL One-Step RT-PCR
|One-Step RT-PCR BCR-ABL p210||RQ-105-48/96||48/96 tests|
|Standard for RT-PCR BCR-ABL p210||RQ-54-ST||5 x 110 ul|
|BCR-ABL p210 Reference||05-64-06||4 x 15 ul|