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Published on: December 15, 2017
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[Comparison of quantitative detection of BCR::ABL1 p210 transcript levels: a multicenter study].
1SINO-US Diagnostics Lab, Tianjin Enterprise Key Laboratory of Al-aided Hematopathology Diagnosis, Tianjin 300385, China.
Summary
This study compared BCR::ABL1 p210 transcription level detection across seven labs. Digital PCR (dPCR) showed higher detection rates than real-time PCR (RT-PCR) for low levels, indicating dPCR
Area of Science:
- Molecular Diagnostics
- Oncology
- Laboratory Medicine
Background:
- Accurate quantification of BCR::ABL1 p210 is crucial for monitoring chronic myeloid leukemia.
- Interlaboratory variability can impact treatment decisions.
- Standardization of detection methods is essential for reliable results.
Purpose of the Study:
- To evaluate the performance of seven reference laboratories in detecting BCR::ABL1 p210 transcription levels.
- To compare the results obtained using real-time quantitative PCR (RT-PCR) and digital PCR (dPCR).
- To assess the consistency and comparability of BCR::ABL1 p210 quantification across laboratories.
Main Methods:
- An interlaboratory comparison study involving seven reference medical laboratories.
- Preparation of samples with varying BCR::ABL1 p210 quantitative values (0.001% to >10%).
- Detection of BCR::ABL1 p210 using both RT-PCR and dPCR techniques.
- Calculation and validation of conversion factors (CF) for each laboratory.
Main Results:
- Six out of seven laboratories demonstrated acceptable bias and limits of agreement for both RT-PCR and dPCR.
- Both RT-PCR and dPCR successfully detected BCR::ABL1 p210 at levels from 0.01% upwards.
- dPCR exhibited a higher detection rate (85.56%) compared to RT-PCR (68.00%) for BCR::ABL1 p210 levels of 0.001%-0.01%.
Conclusions:
- Good consistency in BCR::ABL1 p210 detection was observed among participating laboratories.
- Conversion factors enable comparability of quantitative BCR::ABL1 p210 values across different labs.
- dPCR offers advantages over RT-PCR for deep molecular reaction monitoring due to its higher positive detection rate at low levels.
- Enhanced daily quality control is vital for ensuring accuracy and reproducibility of BCR::ABL1 p210 testing.
