An Automated Cartridge-Based Microfluidic System for Real-Time Quantification of BCR::ABL1 Transcripts in Chronic...

Area of Science:

• Hematology
• Molecular Diagnostics
• Oncology

Background:

• Chronic myeloid leukemia (CML) is driven by the BCR::ABL1 fusion gene.
• Monitoring BCR::ABL1 transcript levels via RT-qPCR is crucial for assessing treatment efficacy in CML patients.
• Current monitoring methods require validation for new diagnostic platforms.

Purpose of the Study:

• To evaluate the Xpert® BCR-ABL Ultra assay as a reliable alternative for quantifying BCR::ABL1 transcripts in CML patients.
• To assess the concordance of results obtained with the Xpert® BCR-ABL Ultra assay against established laboratory reference methods.
• To confirm the suitability of the Xpert® BCR-ABL Ultra for routine clinical monitoring of CML.

Main Methods:

• The Xpert® BCR-ABL Ultra assay was evaluated in four specialized Italian laboratories using 129 CML patient samples and quality control materials.
• Assessed were test repeatability, specificity, and stability.
• Concordance analysis of BCR::ABL1%IS values and molecular response (MR) classifications was performed using EUTOS criteria, Bland-Altman analysis, and European LeukemiaNet recommendations.

Main Results:

• The Xpert® BCR-ABL Ultra assay demonstrated high repeatability and stability.
• Strong concordance was observed between BCR::ABL1%IS values generated by the Xpert® assay and local reference methods.
• Molecular response classifications were consistent across different platforms, indicating reliable performance.

Conclusions:

• The Xpert® BCR-ABL Ultra assay is a robust, accurate, and efficient tool for quantifying BCR::ABL1 transcripts.
• The assay provides reliable results comparable to existing validated systems.
• Xpert® BCR-ABL Ultra is a suitable alternative for routine clinical monitoring of CML patients, supporting treatment efficacy assessment.