ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit CE

• MMR, MR4, and MR4.5 status reporting
• Results directly aligned on the International Scale (IS)
• An IS-MMR calibrator aligned with World Health Organization’s (WHO) reference material to prevent intra- and inter-lab variation in every run
• High reliability using EAC technology and single plasmid standards
• Ready-to-use solutions including all reagents for RT and qPCR, validated on Rotor-Gene Q MDx 5Plex HRM

The ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit is a quantitative, in vitro diagnostic test for the measure of the BCR-ABL1 fusion gene b3a2 (e14a2) and b2a2 (e13a2) transcripts in total RNA extracted from whole blood.

The kit is intended to monitor deep molecular response in patients diagnosed with chronic phase Philadelphia chromosome positive (Ph+) p210 chronic myeloid leukemia (CML).

The kit is calibrated against the WHO International Genetic Reference Panel and runs on Rotor-Gene Q MDx 5plex HRM using real-time PCR technology. The kit provides all necessary reagents and is optimized for improved sensitive detection and quantification of BCR-ABL1 p210 b2a2 or b3a2 transcripts, relative to ABL1 control gene expression.

To ensure the highest sensitivity and to achieve MR4.5 status, the ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit has been optimized to detect very low levels of BCR-ABL1 p210 b2a2 or b3a2 transcripts. The limit of detection (LOD) is 3.21 CNMbcr (corresponding to a LOD of 0.0030%) and the limit of blank (LOB) is 1.02 copies of BCR-ABL1 Mbcr transcript with ABL1CN = 100 000.

Theipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit is a ready-to-use kit for the detection of BCR-ABL1 p210 b2a2 or b3a2 transcripts using real-time PCR. The kit is based on the amplification and detection of specific BCR-ABL1 p210 b2a2 or b3a2 transcripts, relative to ABL1 control gene expression, in total RNA. The kit provides high levels of specificity, sensitivity, and reproducibility. Each kit contains 4 standard dilutions for ABL1, and 5 standard dilutions for BCR-ABL1 Mbcr. Use of a single plasmid for BCR-ABL1 and ABL1 enables reproducible quantification of transcripts and limits variability. Primers and probe sets are designed according to Europe Against Cancer (EAC) recommendations. The kit also includes an IS-MMR calibrator allowing direct conversion of results to the International Scale at each run for accurate measurement of molecular responses, including major molecular response (MMR), MR4 and MR4.5 — also known as deep molecular response (DMR). The IS-MMR calibrator is included within every run to prevent intra- and inter-lab variation. High and low positive controls RNA are also included to monitor the reverse transcription and amplification steps of ABL1, and BCR-ABL1 Mbcr during transcript quantification.

The ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit is provided with all necessary reagents for reverse transcription of total RNA into cDNA, followed by the amplification of cDNA by real-time PCR on Rotor-Gene Q MDx 5plex HRM, with the use of sensitive enzymes. Using this kit allows detection and quantification of BCR-ABL1 p210 b2a2 or b3a2 and ABL1 transcripts. Simply start the reaction using the optimized protocols described in the kit handbook. Results analysis and interpretation is now automated and simplified with the Rotor-Gene AssayManager v2.1 software.

Theipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit enables sensitive and reliable detection and quantification of BCR-ABL1 p210 b2a2 or b3a2 transcripts, conversion of results to the International Scale (IS), MMR and MR4.5 reporting. The kit is CE marked and is intended to monitor deep molecular response in patients diagnosed with chronic phase Philadelphia chromosome positive (Ph+) p210 chronic myeloid leukemia (CML).