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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.

Archives of Pathology & Laboratory Medicine
|July 26, 2014
PubMed
Summary
This summary is machine-generated.

Standardizing BCR-ABL1 testing improves chronic myeloid leukemia management. Conversion and correction methods enhance accuracy and precision for monitoring residual disease globally.

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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.