gb ONCO BCR-ABL DETECT
The CE IVD real-time PCR kit is intended for a qualitative determination of a type of the BCR-ABL1 fusion gene alteration. Apart from commonly occurring fusions the kit detects rare alterations as well. Detection method based on one-step RT-qPCR ensures quick, less laborious and, above all, semiquantitative determination of the fusion type, while sophisticated system of controls ensures validity of the result and its adequate interpretation.
Clinical implications
The gb ONCO BCR-ABL DETECT diagnostic kit enables the identification or detection of the BCR-ABL1 fusion gene breakpoints variants in patients with a hemato-oncological disease.
The aim of BCR-ABL1 breakpoint variant determination is the confirmation of a diagnosis, the determination of a prognosis and the setting up of a treatment plan for patients with e.g. chronic myeloid leukaemia (CML), acute lymphoblastic leukaemia (ALL) and for patients after bone marrow transplantation.
Principle of detection
The test is based on one-step RT-qPCR using fluorescently labeled probes. The kit enables detection of the following BCR-ABL1 fusion variants:
|
FAM/SYBR |
HEX/JOE/VIC |
ROX |
Cy5 |
Assay BCR-ABL DETECT 1 |
e14a2 |
e13a2 |
reference GUSB |
e14a3
e13a3 |
Assay BCR-ABL DETECT 2 |
e1a2
e1a3 |
e19a2
e19a3 |
e6a2 |
reference GUSB |
The validity of the analysis of the samples is evaluated according to the level of the reference GUSB gene transcript and the homogeneity of its analysis by both of the assays.
Parametres of the diagnostic kit
- in vitro diagnostics
- CE IVD marked
- detection in the following channels: FAM, HEX, ROX, and Cy5