Analytical Performance Evaluation of a Digital Real-Time PCR for Quantifying Major BCR::ABL1 Transcripts.

Area of Science:

• Hematology
• Molecular Diagnostics
• Oncology

Background:

• Accurate quantification of BCR::ABL1 transcripts is crucial for monitoring measurable residual disease (MRD) in chronic myeloid leukemia (CML).
• Tyrosine kinase inhibitor (TKI) treatment necessitates reliable MRD detection methods for patient management.
• Evaluating novel diagnostic tools is essential for improving MRD monitoring in CML.

Purpose of the Study:

• To evaluate the performance of a new digital real-time PCR (Dr. PCR) method for MRD detection in CML.
• To compare the efficacy of Dr. PCR against the established quantitative reverse transcription PCR (qRT-PCR) method.
• To assess the clinical utility and practical advantages of Dr. PCR in MRD monitoring.

Main Methods:

• Dr. PCR performance was assessed using reference and clinical materials.
• Precision, linearity, and correlation with qRT-PCR were evaluated.
• MRD levels and ABL1 copy numbers were compared between Dr. PCR and qRT-PCR.

Main Results:

• Dr. PCR demonstrated excellent precision and linearity, detecting MRD down to 0.0032%IS (MR4.5).
• A strong correlation was observed between Dr. PCR and qRT-PCR results.
• Dr. PCR identified higher MRD levels in 12.7% of patients and required fewer repeat tests compared to qRT-PCR.

Conclusions:

• Dr. PCR is a rapid, efficient, and clinically applicable method for MRD assessment in CML patients.
• The study supports the use of Dr. PCR as a valuable tool for MRD monitoring in CML.
• Dr. PCR offers advantages over qRT-PCR, potentially improving patient management and treatment decisions.