- Quantitative test that allows detecting the number of copies of the M-BCR-ABL1 rearrangement (p210), and the number of copies of the endogenous ABL1 gene, and the expression of the result according to the International System.
- 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 (p210) 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 4.5 log reduction from the International Randomized study defined as:
- Detectable disease < 0.0032% BCR-ABL1
- Undetectable disease in cDNA with > 32,000 copies of the ABL1 reference gene.
- It includes a standardized calibrator for the determination of the normalized copy number of M-BCR-ABL1: the pIMEGEN vector (M-BCR-ABL1:ABL1 in a 1:1 copy ratio) calibrated from the IRMM Reference Material [ERM -AD623]).
- It complies with the quality requirements specified by ISO 13485 and ISO 14001 in relation to the materials used in its manufacturing process.
- For in vitro diagnostic use only.
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