PHILADELPHIA P210 RNA Reference

The «PHILADELPHIA P210 RNA Reference» is a secondary reference material, intended for validation of every RT-PCR assays used in detection and quantitation of BCR-ABL1 gene. The «PHILADELPHIA P210 RNA Reference» can be used for the calculation of an assay-specific conversion factor to express the quantitative results in the BCR-ABL1 International Scale (IS). Expression of results in International Scale is fundamental to evaluate the disease progression and the treatment efficacy, in patients with chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL) previously diagnosed with a BCR-ABL P210 fusion gene. The product includes 5 vials, containing the total mRNA of BCR-ABL positive and negative human cell lines mixed at different ratios. The panel concentrations cover an extended dynamic range, from MR1 to MR 4.5, to allow assay evaluation at every clinical range. The material is traceable to the BCR-ABL1 International Standard and manufactured according to the WHO recommended calibration method (ref. 1st World Health Organization International Genetic Reference Panel for Quantitation of BCR-ABL Translocation)