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

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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

View our video resources.

Posters

• Method Comparison Between Two Commercially Available BCR-ABL1 Quantitative Kits. Lara A, Beldorth I, Jefferson K, Brown J. AMP 2021.
  
• Validation of BCR-ABL1 Test Performance from Whole Blood Stored up to 72 Hours Facilitates Operational Flexibility and Expanding Locally Managed CML Monitoring. Beldorth I, Masson K, Fahey M, Ruskin A, Andruss B, Brown J. John Goldman ESH-iCMLf 2018 (European School of Hematology International CML Foundation).
  
• BCR-ABL1 Molecular Responses at 12-18 Months Predict Long-Term Event-Free Survival in Patients with Tyrosine Kinase Inhibitor (TKI)-Treated Chronic Myelogenous Leukemia (CML). Press R, Watt C, Cai L, Van Deerlin V, Roth J, Gentile C, Loren A, and Eickelberg G. AMP 2016.
  

Publications and Articles

• Analytical Validation of a Highly Sensitive, Multiplexed Chronic Myeloid Leukemia Monitoring System Targeting BCR-ABL1 RNA. Brown et al. J Mol Diagn. 2019 Jul;21(4):718-733.
• As CML Outcomes Improve, Demand Rises for BCR::ABL1 Testing. Brown, J. Clinical Lab Products. 2023.
• Asuragen’s QuantideX® qPCR BCR-ABL IS Kit Receives FDA Premarket Clearance for Monitoring Minimal Residual Disease in Chronic Myeloid Leukemia. Business Wire. 2016.

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

View our video resources.

Posters

• QuantideX qPCR BCR-ABL IS Kit and ipsogen BCR-ABL1 Mbcr IS-MMR Kit Yield Highly Correlated Results. Lara A, Beldorth I, Jefferson K, Brown J. John Goldman ESH-iCMLf 2021 (European School of Hematology International CML Foundation).
  
• Validation of BCR-ABL1 Test Performance from Whole Blood Stored up to 72 Hours Facilitates Operational Flexibility and Expanding Locally Managed CML Monitoring. Press R, Watt C, Cai L, Van Deerlin V, Roth J, Gentile C, Loren A, and Eickelberg G. AMP 2016.
  
• BCR-ABL1 Molecular Responses at 12-18 Months Predict Long-Term Event-Free Survival in Patients with Tyrosine Kinase Inhibitor (TKI)-Treated Chronic Myelogenous Leukemia (CML). Beldorth I, Masson K, Fahey M, Ruskin A, Andruss B, Brown J. John Goldman ESH-iCMLf 2018 (European School of Hematology International CML Foundation).
  

Publications and Articles

• Analytical Validation of a Highly Sensitive, Multiplexed Chronic Myeloid Leukemia Monitoring System Targeting BCR-ABL1 RNA. Brown et al. J Mol Diagn. 2019 Jul;21(4):718-733.
• As CML Outcomes Improve, Demand Rises for BCR::ABL1 Testing. Brown, J. Clinical Lab Products. 2023.
• Asuragen, Inc. Announces Launch Of Highly Sensitive CE-IVD BCR-ABL Assay At The European Hematology Association Annual Congress. BioSpace. 2015.

Browse all Publications

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