gb ONCO BCR-ABL MAJOR / ABL
one-step real-time PCR
CE IVD diagnostic kit enables detection and quantification of b2a2 (e13a2) and b3a2 (e14a2) BCR-ABL1 MAJOR fusion gene transcript variants. The detection is based on one-step RT-qPCR using fluorescently labelled probes. The quantification is evaluated as the copy number percentage ratio of BCR-ABL1 fusion transcripts to ABL1 reference gene transcripts. The detection and quantification of both fusion and reference gene transcripts is performed in one tube.
The BCR-ABL1 MAJOR fusion gene variant occurs in 95% patients with chronic myelogenous leukemia (CML) and in 25% patients with acute lymphocytic leukemia (ALL). The chromosomal aberration leads to the dysregulation of the tyrosine kinase signaling pathway and to the manifestation of the oncological disease.
The response of the patient to the treatment and the minimal residual disease is monitored under recommendation through the quantification of the b2a2 (e13a2) and b3a2 (e14a2) BCR-ABL1 MAJOR fusion transcripts related to the reference gene transcripts. The conversion of the results into the International Scale (IS) units is enabled by using STANDARD MMR BCR-ABL MAJOR (cat. no. 3280-004), which is verified for such purpose by the National Reference Laboratory of the Institute of Hematology and Blood Transfusion, Prague.
- kit contents – Assay BCR-ABL MAJOR/ABL, Master Mix BCR-ABL, series of calibration standards, negative control
- reverse transcriptase and quantification PCR (detection) is performed in one step in one tube
- detection of the BCR-ABL1 fusion gene in the FAM channel, ABL1 reference gene in HEX
- reaction volume 25 µl
- conversion to the International Scale (IS) using STANDARD MMR BCR-ABL MAJOR (cat. no. 3280-004)
- the calculator (MS Excel) for data evaluation facilitation provided
Light Cycler 480/Cobas z480 (Roche Diagnostics)
QuantStudio 5 (Applied Biosystems)
RG 3000 (Corbett Research)