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- QuantideX - qPCR BCR-ABL IS Kit
QuantideX - qPCR BCR-ABL IS Kit
Assessing complete molecular response requires the highest possible assay sensitivity. The FDA-cleared QuantideX® qPCR BCR-ABL IS Kit takes chronic myeloid leukemia (CML) monitoring to a new level of sensitivity – 0.002% IS (MR4.7). It’s a qPCR-based in vitro Diagnostic test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.
The QuantideX qPCR BCR-ABL IS Kit’s unprecedented level of sensitivity coupled to a simple-to-run, singlicate test, allows labs to reliably and reproducibly monitor much deeper molecular response.
Reduced Complexity
Ease-of-data analysis and reporting:
- Direct reporting on the International Scale (IS): No sample exchange or conversion factor calculations required
- QuantideX qPCR Reporter eliminates manual intervention to provide automated calculations and streamlined reporting
Optimized Workflow
Valuable operator hands-on time has been significantly reduced through:
- Multiplexed design 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 reagents leading to fewer pipetting steps in the mastermix preparation
Quality Performance
Detecting BCR-ABL Transcripts robustly, reliably with a highly sensitive assay:
- Limit of Detection (LOD) of MR4.7 (0.002%IS): 95% detection at LOD as determined using human RNA specimens
- Increased analytical sensitivity without compromising analytical specificity: Non-CML (major) transcripts not detected in assay
- Armored RNA®-based standards providing true RNA quantification for a quantitative RNA assay
- Robust performance as indicated by minimum variability of replicate measurements