- Quantitative real-time PCR assay to determine the number of copies of the m-BCR-ABL1 (p190) rearrangement, and the number of copies of the endogenous ABL1 gene.
- High sensitivity and specificity: The level of sensitivity that can be achieved depends on the maximum number of copies of the ABL1 reference gene. The detection limit for both ABL1 and m-BCR-ABL1 (p190) has been established at 5 total copies. The quantification limit or minimum quantifiable value has been established at 50 total copies.
- This kit is suitable for detecting a molecular response corresponding to a 4 log reduction from the International Randomized study defined as:
- Detectable disease < 0.01% BCR-ABL1
- Undetectable disease on cDNA with > 10,000 copies of the ABL1 reference gene.
- Includes a standard calibrated with the IRMM Reference Material [ERM-AD623] for the relative quantification of the number of copies of the m-BCR-ABL1 rearrangement (p190) with respect to the number of copies of the ABL1 gene.
- It complies with the quality requirements specified by ISO 13485 and ISO 14001 regarding the materials used in its manufacturing process.
- For in vitro diagnostic use only.
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