QuantideX® qPCR BCR-ABL minor Kit

The QuantideX qPCR BCR-ABL minor Kit marries improved efficiency with unprecedented sensitivity, empowering labs to assess the deepest molecular responses in patients harboring the minor breakpoint with the ease-of-use they’ve come to expect from Asuragen.

Reduced Complexity | Ease-of-data analysis and reporting:

• Shares a common workflow with the QuantideX® qPCR BCR-ABL IS Kit to reduce training burden and streamline test implementation
• Included software provides automated calculation of BCR-ABL1/ABL1 % ratio and the ability to report BCR-ABL Major on both the International Scale (IS) and copy number*

Optimized Workflow | 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

Quality Performance | Detecting BCR-ABL Minor Transcripts robustly, reliably with a highly sensitive assay:

• Ultra-sensitive Limit of Detection (LOD): Log reduction of 4.61 (0.0025% ratio)
• Increased analytical sensitivity without compromising analytical specificity: incorporates Limit of Blank (LOB) to prevent miscalling of non-leukemic low positives
• Armoured RNA based standards providing true RNA quantification for a quantitative RNA assay

Analytical Characteristics

• Proven sensitivity based on rigorous testing criterion (Table 1)
• Minimal variability across the entire dynamic range of BCR-ABL1/ABL1 % ratios (Table 2)
• Multiplexed design leads to workflow and cost efficiency (figure 1)

Proven Sensitivity Based on Rigorous Testing Criterion

Table 1: LOD as determined by CLSI EP-17A2 guidelines by testing Human RNA and cell line dilutions spanning lots, batch runs, days, operators and instruments.

Minimal Variability Across Entire Dynamic Range

Table 2. Assay precision determined by testing 4 different log reduction (LR) levels in human RNA, using 2 operators and 8 runs for a total of 192 data points.

Multiplexed Design Leads to Workflow and Cost Efficiency

Figure 1: Comparison of a plate layout for 8 sample run on Asuragen plate (left) and an alternate non-multiplex assay (right): 19 reactions for Asuragen setup vs. 52 reactions on a non-multiplex assay setup