Features & Benefits

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

Analytical Characteristics

• Proven sensitivity based on rigorous testing criterion (Table 1)
• Minimal variability across entire dynamic range of %IS values (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 EP17-A2 guidelines by testing Human RNA dilutions ranging from MR4.4 to MR6: 60 replicates of each dilution for a total of 1680 data points

Minimal Variability Across Entire Dynamic Range of %IS Values
Table 2: Precision evaluated by testing 5 different MR levels, using 3 operators, 9 runs for a total of 450 data points
*The fold change column represents summarized data for clarification purpose only. To see full precision data, please refer to Table 4 of the Instruction for Use.

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. 60-64 reactions on a non-multiplex assay setup

Additional Resources

Videos

 

Defining the Standard of Care: FDA-Cleared, Clinically Proven CML Monitoring at the MR 4.7 Level

 

Analytical Validation of a BCR-ABL1 Monitoring System that Surpasses Current Testing Requirements

Posters

BCR-ABL1 Monitoring on the IS Using a Clinically and Analytically Validated Multiplex Assay Directly Aligned to the WHO Primary Standards and that Unifies Reporting Formats
View full poster

Modifications to RNA Isolation Protocols Meet Requirements for Modern CML Monitoring of BCR-ABL1 Transcript Levels
View full poster

Validation of BCR-ABL1 Test Performance from Whole Blood Stored up to 72 Hours Facilitates Operational Flexibility and Expanding Locally Managed CML Monitoring
View full poster

Publications

Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. White et. al. Blood. 2010;116(22):e111-7. doi: 10.1182/blood-2010-06-291641. Epub 2010 Aug 18

Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR-ABL1 on the international reporting scale. Brown et. al. Blood Cancer J. 2011;1(3):e13. doi: 10.1038/bcj.2011.10. Epub 2011 Mar 25

Establishment and validation of analytical reference panels for the standardization of BCR-ABL1 quantitative measurements on the international scale. White et. al. Clin Chem. 2013 Mar 7. [Epub ahead of print]

Browse all Publications

The test is not intended for the diagnosis of CML or for monitoring rare transcripts resulting from t(9;22).

Features & Benefits

The QuantideX qPCR BCR-ABL IS Kit provides labs with a robust and reliable method for monitoring leukemia patients, also allowing them to keep pace with the advances in TKI therapy.

Reduced Complexity
Ease-of-data analysis and reporting:

• Direct reporting on the International Scale (IS): No sample exchange or conversion factor calculations required
• Data analysis software eliminates manual intervention to provide automated calculations and streamlined reporting

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 Transcripts robustly, reliably with a highly sensitive assay:

• Sensitivity of MR4.7 (0.002%IS): 95% positivity at this LOD as determined by testing human RNA specimens
• Increased sensitivity without compromising specificity: Non-CML (major) transcripts not detected by the assay
• Armored RNA based standards providing true RNA quantification for a quantitative RNA assay
• Robust performance as indicated by minimum variability of replicate measurements

Analytical Characteristics

• Proven sensitivity based on rigorous testing criterion (Figure 1)
• Minimal variability across the entire dynamic range of % IS values (figure 2)
• Multiplexed design leads to workflow and cost efficiency (figure 3)

Proven Sensitivity Based on Rigorous Testing Criterion

Figure 1: LOD as determined by CLSI EP17-A2 guidelines by testing Human RNA dilutions ranging from MR4.4 to MR6: 60 replicates of each dilution for a total of 1260 data points

Minimal Variability Across Entire Dynamic Range of %IS Values

Figure 2. Precision was evaluated by using 5 different levels of positive specimen, tested by 3 operators over 20 runs. Each level was tested 40 times to obtain Standard Deviations

Multiplexed Design Leads to Workflow and Cost Efficiency

Figure 3: 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. 60-64 reactions on a non-multiplex assay setup

Additional Resources

Videos

 

Defining the Standard of Care: FDA-Cleared, Clinically Proven CML Monitoring at the MR 4.7 Level

 

Analytical Validation of a BCR-ABL1 Monitoring System that Surpasses Current Testing Requirements

Posters

BCR-ABL1 Monitoring on the IS Using a Clinically and Analytically Validated Multiplex Assay Directly Aligned to the WHO Primary Standards and that Unifies Reporting Formats
View full poster

Modifications to RNA Isolation Protocols Meet Requirements for Modern CML Monitoring of BCR-ABL1 Transcript Levels
View full poster

Validation of BCR-ABL1 Test Performance from Whole Blood Stored up to 72 Hours Facilitates Operational Flexibility and Expanding Locally Managed CML Monitoring
View full poster

Publications

Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. White et. al. Blood. 2010;116(22):e111-7. doi: 10.1182/blood-2010-06-291641. Epub 2010 Aug 18

Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR-ABL1 on the international reporting scale. Brown et. al. Blood Cancer J. 2011;1(3):e13. doi: 10.1038/bcj.2011.10. Epub 2011 Mar 25

Establishment and validation of analytical reference panels for the standardization of BCR-ABL1 quantitative measurements on the international scale. White et. al. Clin Chem. 2013 Mar 7. [Epub ahead of print]

Browse all Publications

The test is not intended for the diagnosis of CML or for monitoring rare transcripts resulting from t(9;22).