Comparative study of BCR-ABL1 quantification: Xpert assay, a feasible solution to standardization concerns

Area of Science:

• Hematology
• Molecular Diagnostics
• Oncology

Background:

• BCR-ABL1 transcript levels predict treatment response and survival in chronic myeloid leukemia (CML).
• Standardization and interpretation of BCR-ABL1 quantification methods remain inconsistent.
• Accurate molecular monitoring is crucial for effective CML management.

Purpose of the Study:

• To compare the European Leukemia Net (ELN)-recommended method with an automated Xpert BCR-ABL™ assay for BCR-ABL1 quantification.
• To evaluate the concordance and reproducibility of the automated method in CML patients.
• To assess the utility of the Xpert BCR-ABL™ assay for clinical decision-making in CML.

Main Methods:

• BCR-ABL1 transcript levels were quantified in 117 CML patient samples using both the ELN-recommended method and the automated Xpert BCR-ABL™ assay.
• Samples were analyzed in two independent laboratories to ensure robustness.
• Statistical analyses were employed to compare results, including concordance rates and assessment of major molecular response (MMR).

Main Results:

• A high linear correlation was observed between the ELN-recommended method and the Xpert BCR-ABL™ assay.
• Concordance at logarithmic intervals reached 62%, with 85% agreement for major molecular response (MMR) classification.
• The automated Xpert method demonstrated reproducible results without significant differences compared to the traditional method.

Conclusions:

• The automated Xpert BCR-ABL™ assay is a reliable and reproducible method for monitoring BCR-ABL1 levels in CML patients.
• The Xpert assay accurately classifies patients achieving MMR, supporting its use in clinical practice.
• This automated method offers a valuable alternative for the molecular follow-up of CML, enhancing standardization and potentially improving patient management.