BCR-ABL
The SensiQuant products are designed for the QUALITATIVE detection and QUANTITATIVE measurement of BCR/ABL transcripts in patients suspected of having Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Acute Lymphoblastic Leukemia (ALL).
The product line includes:
- SensiQuant Master Mix
- SensiQuant Standard (from 10^5 to 10 copies)
- SensiQuant Positive Control
- PhilaREF (RNA, from 10% to 0.0032% + Neg)*
- Lyoset Reference (lyophilized cells, from 10% to 0.0032% + Neg)
- “major” (M-bcr), P210 (b2a2/b3a2) and rare variant b3a3/b2a3
- “minor” (m-bcr), P190 (e1a2) and rare variant e1a3
- “micro” (u-bcr), P230 e19a2/e19a3
- “nano” (n-bcr), e6a2/e6a3
- QUALITATIVE Analysis = SensiQuant Master Mix + SensiQuant Positive Control
- QUANTITATIVE Analysis = SensiQuant Master Mix + SensiQuant Standard
- PhilaREF: RNA reference material for qualitative or quantitative performance assessment of translocation detection assays and, for the P210 transcript, for the calculation of the Conversion Factor (CF)* needed to express final BCR/ABL P210 quantification data on the International Scale (IS).
- Lyoset Reference: reference material consisting of ampoules with lyophilized mixtures of known quantities of cells positive for the targeted translocation diluted in negative cells. Essential for qualitative or quantitative performance assessment of translocation detection assays.
- One-Step Technology
- Single plasmid of BCR-ABL and ABL
- Linear Range (1,000,000 to 5 copies BCR-ABL for the most common variants)
- Consistent thermal cycling conditions across different translocations (analyzable in a single run)
- High ABL copy numbers (high sensitivity of the method)
- High specificity, sensitivity, and accuracy (0.00001% of Ph-positive cells in wild-type cells*)
- High reproducibility (intra- and inter-assay)
- Fast and easy to use
- High stability
- CE/IVD marking for the most common variants
- LabNet validated (R.I.L. CML LabNet – Feb2023 – v 5.0)*