Key Features and Values
Ease-of-data analysis and reporting:
- Direct reporting on the International Scale (IS): No sample exchange or conversion factor calculations required
- Data analysis software eliminates manual intervention to provide automated calculations and streamlined reporting
Valuable operator hands-on time has been significantly reduced through:
- Multiplexed assay design that amplifies and detects both fusion and control gene in the same reaction
- All-inclusive reagents sourced and Quality Controlled together from a single vendor
- Pre-mixed tubes leading to fewer pipetting steps in the mastermix preparation
Detecting BCR-ABL Transcripts with a highly sensitive assay:
- Sensitivity of MR4.7 (0.002%IS): 95% positivity at this LOD as determined by testing human RNA specimens
- Increased sensitivity without compromising specificity: Non-CML (major) transcripts not detected by the assay
- Armored RNA based standards providing true RNA quantification for a quantitative RNA assay
- Robust performance as indicated by minimum variability of replicate measurements
The QuantideX® qPCR BCR-ABL IS Kit is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QuantideX qPCR BCR-ABL IS Kit is a reverse transcription-quantitative PCR performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument or the cobas z 480 Analyser and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).
The Test does not differentiate between e13a2 or e14a2 fusion transcripts, and does not monitor other rare fusion transcripts resulting from t(9;22). This Test is not intended for the diagnosis of t(9;22) positive CML.
The Philadelphia (Ph) chromosome, a t(9;22) reciprocal translocation between the ABL1 gene on chromosome 9 and the BCR gene on chromosome 22, generates the chimeric gene BCR-ABL1. Most Philadelphia chromosomes present the rearrangement in the major breakpoint cluster region encoding a 210 kD chimeric protein. This p210 chimeric protein is translated from either exon 13 (e13a2 junction) or exon 14 (e14a2 junction) of the BCR gene juxtaposed to exon 2 of the ABL1 gene. Less common rearrangements exist (e.g. the minor breakpoint region encoding a 190 kD chimeric protein generated from the e1a2 junction). However, the Test does not monitor e1a2 or other rare fusion transcripts resulting from t(9;22).
Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. White et. al. Blood. 2010;116(22):e111-7. doi: 10.1182/blood-2010-06-291641. Epub 2010 Aug 18
Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR-ABL1 on the international reporting scale. Brown et. al. Blood Cancer J. 2011;1(3):e13. doi: 10.1038/bcj.2011.10. Epub 2011 Mar 25
Establishment and validation of analytical reference panels for the standardization of BCR-ABL1 quantitative measurements on the international scale. White et. al. Clin Chem. 2013 Mar 7.