Xpert BCR-ABL Ultra is a quantitative test for BCR-ABL major breakpoint (p210) transcripts that provides highly sensitive and on-demand molecular results. Based on the innovative GeneXpert technology, Xpert BCR-ABL Ultra automates the entire test process including RNA isolation, reverse transcription, and fully nested real-time PCR of BCR-ABL target gene and ABL reference gene in one fully automated cartridge.,
Benefits:- 2.5 hours for the total process
- Simply add the treated blood sample and an off-board reagent to the Xpert cartridge
- The results are aligned to the IS lot-to-lot through secondary standards calibrated to the BCR-ABL WHO panel
- 4 mL input volume of whole blood ensures reproducible detection of low-level transcripts
- High sensitivity and low inter-laboratory variation8
- Clinically demonstrated limit of detection of <4.5-log reduction (0.0032%)8
- Same day information supports informed clinical decisions, including inclusion in treatment discontinuation research
- Faster results reduce patient anxiety9
- Flexibility and simplicity for more streamlined workflow
- Eliminates need for standard curve and replicate testing
- Frees up technician time for other lab services
- Any number of samples, any day of the week with a fixed cost per reportable result
- One page report with results aligned to the IS
Performance:The clinical performance of Xpert BCR-ABL was evaluated by comparison with an in-house assay based on the Europe Against Cancer (EAC) standardized 'real-time' quantitative reverse transcriptase polymerase chain reaction (RQ-PCR) of fusion gene transcripts for residual CML disease.
10 This routine assay was calibrated for the ABL reference gene and BCR-ABL target gene using the Institute for Reference Materials and Measurements (IRMM) plasmid dilutions. In the study, peripheral blood was acquired prospectively from subjects with CML into EDTA tubes. Each specimen was split for comparison testing with the routine assay and the Xpert BCR-ABL Ultra assay. Total recruitment included 54 subjects whose paired results were within the detectable range of both assays.
(8) Cepheid Xpert BCR-ABL Ultra Package Insert 301-2194.;
(9) Cepheid Europe Survey of LMC France (French CML Association). Improving the Quality of Life for Your CML Patients: A Patient Survey Analysis. 2014.Cepheid Europe Survey of LMC France (French CML Association). Improving the Quality of Life for Your CML Patients: A Patient Survey Analysis. 2014.;
(10) Gabert J, et al. Standardization and quality control studies of 'real-time'quantitative reverse transcriptase polymerase chain reaction (RQ-PCR) of fusion gene transcripts for residual disease detection in leukemia – A Europe Against Cancer Program: Leukemia. 2003 Dec;17(12):2318-57.;