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Conversion, correction, and International Scale standardization: results From a Multicenter External Quality
Michael Griffiths1, Simon J Patton, Alberto Grossi
1From West Midlands Regional Genetics Laboratory, Birmingham Women's NHS Foundation Trust, and School of Cancer Sciences, University of Birmingham, Birmingham, United Kingdom (Mr Griffiths); the European Molecular Genetics Quality Network, Manchester Centre for Genomic Medicine, St Mary's Hospital, Manchester, United Kingdom (Dr Patton); Oncology Unit, Ospedale di Prato, Prato, Italy (Dr Grossi); United Kingdom National External Quality Assessment Schemes, Sheffield, United Kingdom (Mr Clark); Labceutics, Belfast, United Kingdom (Dr Fe Paz); and Asuragen, Austin, Texas (Dr Labourier). Mr Clark is now with Labceutics, Belfast, United Kingdom.
Standardizing BCR-ABL1 testing improves chronic myeloid leukemia management. Conversion and correction methods enhance accuracy and precision for monitoring residual disease globally.
Area of Science:
- Hematology
- Molecular Diagnostics
- Clinical Chemistry
Background:
- Monitoring BCR-ABL1 expression is crucial for chronic myeloid leukemia (CML) management.
- Significant variability exists in BCR-ABL1 testing across laboratories worldwide.
- Standardization to the International Scale (IS) is vital for consistent patient care.
Purpose of the Study:
- Assess method performance and interlaboratory precision of BCR-ABL1 testing.
- Evaluate different International Scale (IS) standardization modalities.
- Improve accuracy and precision of BCR-ABL1 quantification.
Main Methods:
- 15 laboratories tested blinded specimens and secondary reference panels.
- Relative quantitative polymerase chain reaction (PCR) was employed.
- Data analyzed raw ratios, conversion factors (CFs), and correction parameters (CPs).
Main Results:
- Intralaboratory precision was within 2.5-fold, but interlaboratory differences exceeded 5-fold.
- Both CF and CP standardization methods improved International Scale (IS) accuracy.
- Classification agreement for major molecular response reached 93% with CP correction.
Conclusions:
- Conversion and correction are effective IS standardization methods despite laboratory variations.
- Validated secondary reference materials aid global IS diffusion without sample exchange.
- Improved accuracy and precision enhance BCR-ABL1 measurements, especially for low residual disease levels.
