Products
Features
- Highly accurate and sensitive quantitative assay
- EAC standardized assay for reproducible results
- Compliance with EU IVD Directive 98/79/EC
- Easy workflow with ready-to-use solutions
Product Details
The ipsogen BCR-ABL1 Mbcr Kit is an in vitro molecular diagnostic kit for real-time PCR on the Rotor-Gene Q and other real-time PCR instruments. The kit provides reagents optimized for reliable and sensitive detection and quantitation of BCR-ABL Mbcr p210 Mbcr b2a2 or b3a2 transcripts, relative to ABL control gene expression, in bone marrow or peripheral blood samples of acute lymphoblastic leukemia (ALL) or chronic myeloid leukemia (CML) patients previously diagnosed with a BCR-ABL Mbcr fusion gene event. The test is intended to evaluate the level of molecular response; results can be used for minimal residual disease follow-up. Major developments in technology and analytical performance are integrated into the ipsogen BCR-ABL1 Mbcr IS-MMR Kit CE, to provide sensitive and accurate results aligned with the International Scale, and allow assessment of Major Molecular Response (MMR).
Performance
To ensure highest sensitivity, the ipsogen BCR-ABL1 Mbcr Kit has been optimized to detect BCR-ABL Mbcr p210 b2a2 or b3a2 transcripts and the ABL control gene using prediluted plasmid standards and primers and probe mixes (see figures Accurate detection of BCR-ABL Mbcr standards and Reliable detection of ABL plasmid standards).
See figures
Principle
The ipsogen BCR-ABL1 Mbcr Kit is a ready-to-use kit for the detection of BCR-ABL Mbcr p210 b2a2 or b3a2 fusion gene transcripts using real-time PCR. The kit is based on the amplification and detection of specific BCR-ABL Mbcr p210 b2a2 or b3a2 transcripts, relative to ABL control gene expression, in total RNA extracted from bone marrow or peripheral blood samples of acute lymphoblastic leukemia (ALL) or chronic myeloid leukemia (CML) patients previously diagnosed with a BCR-ABL Mbcr fusion gene event. The kit provides high levels of specificity, sensitivity, and reproducibility. The ipsogen BCR-ABL1 Mbcr Kit provides 5 standard dilutions for Mbcr and 3 standard dilutions for ABL. Use of the standards enables accurate quantification of transcripts. Specific primers and probe mixes and standard serial dilutions of control and fusion DNA are provided for the quantification of the BCR-ABL1 Mbcr genes and the ABL control gene according to Europe Against Cancer (EAC) recommendations (see figures BCR-ABL Mbcr fusion gene transcript and ABL control gene transcript).
See figures
Procedure
The first step is reverse transcription of total RNA in a sample into cDNA. The second step is the amplification of cDNA by real-time PCR. Using the ipsogen BCR-ABL1 Mbcr Kit allows detection and quantification of BCR-ABL Mbcr p210 b2a2 or b3a2 fusion gene and ABL transcripts. Simply start the reaction using the optimized protocols described in the kit handbook.
Applications
The ipsogen BCR-ABL1 Mbcr Kit enables sensitive and reliable detection and quantification of BCR-ABL Mbcr p210 b2a2 or b3a2 transcripts, relative to ABL control gene expression, for in vitro diagnostic use.
Supporting data and figures
BCR-ABL Mbcr fusion gene transcript.
BCR-ABL Mbcr fusion gene transcript.
Resources
Kit Handbooks (2)
Safety Data Sheets (1)
Certificates of Analysis (1)