A novel approach for BCR-ABL1 standardization to improve International Scale estimation

Area of Science:

• Molecular Biology
• Clinical Chemistry
• Hematology

Background:

• Standardization of BCR-ABL1 mRNA quantification on the International Scale (IS) is crucial for monitoring chronic myelogenous leukemia (CML) treatment.
• Current methods relying on laboratory-specific conversion factors (CFs) are complex and not universally achievable.
• Discrepancies exist between different BCR-ABL1 IS quantification methods.

Purpose of the Study:

• To develop a simplified and alternative approach for calculating the conversion factor (CF) for BCR-ABL1 IS standardization.
• To improve the accuracy and accessibility of BCR-ABL1 quantification for CML therapy monitoring.

Main Methods:

• Developed a novel CF calculation method using retrospective analysis of external quality assessment (EQA) data.
• The approach relies solely on mathematical calculation from EQA results, avoiding sample exchange.

Main Results:

• Statistically validated the proposed method for converting BCR-ABL1 measurements.
• Demonstrated improved IS estimation through the new approach.

Conclusions:

• The developed method offers a valuable alternative for BCR-ABL1 IS quantification.
• This approach enhances the reliability of CML therapy response monitoring.