BCR-ABL1 Duplex One Step RT-dPCR Assay
Precision CML Monitoring on the Roche Digital LightCycler
BCR-ABL1 Duplex One Step RT-dPCR Assay
The Genovo BCR-ABL1 Duplex One Step RT-digital PCR Assay is designed for the absolute quantification of BCR-ABL1 fusion transcripts (e13a2 and e14a2) in whole blood. It provides a highly sensitive monitoring tool for Chronic Myeloid Leukemia (CML) patients, enabling the detection of Deep Molecular Response (DMR). The BCR-ABL1/ABL1 transcript ratio is converted to the WHO International Scale (%IS), enabling comparable molecular response monitoring across laboratories.
The Genovo BCR-ABL1 dPCR Assay delivers unprecedented sensitivity coupled to a simple, single-step workflow, allowing labs to reliably and reproducibly monitor much deeper molecular response.
Optimized Workflow
Complete sample-to-result in under 3 hours with minimal hands-on time:
- Only 2mL EDTA whole blood needed — ACK lysing isolates >1×10⁶ PBMC in 40 minutes
- TRIzol extraction yields >1000ng RNA from PBMC in 30 minutes
- One-step duplex RT-dPCR quantifies BCR-ABL1 and ABL1 simultaneously in ~2 hours
- Automation-compatible platform reduces operator technical requirements
Reduced Complexity
Ease-of-data analysis and reporting for your laboratory:
- Direct reporting on the WHO International Scale (%IS) with kit-specific conversion factor (CF)
- Results reported as both MR value and %IS — MR = log₁₀(100/%IS)
- Fully automated data analysis and report generation
- Single-step RT-dPCR — no separate reverse transcription step needed
Quality Results
Detecting BCR-ABL1 transcripts robustly with a highly sensitive assay:
- Limit of Detection (LoD): MR 5.0 (0.001% IS) with ≥95% detection rate
- Limit of Quantitation (LoQ): MR 4.7 (0.002% IS) with 100% hit rate and CV ≤5%
- Limit of Blank (LoB): 0 copies — no false positives in 102 negative samples
- Intra-assay and inter-assay precision CV ≤5%
- Traceable to WHO International Genetic Reference Panel (R²>0.97)