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Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
Published on: September 16, 2012
Validation and quality control of immunophenotyping in clinical flow cytometry
M A Owens1, H G Vall, A A Hurley
1IMPATH, Inc., 5230 Pacific Concourse Drive, 90045, Los Angeles, CA, USA.
Insights
Clinical flow cytometry for diagnosing blood cancers has advanced significantly. This review details essential validation and quality control procedures for accurate hematopathology analysis in clinical settings.
Area of Science:
- Clinical laboratory science
- Hematopathology
- Immunophenotyping
Background:
- Clinical flow cytometry has evolved from basic lymphocyte analysis to complex evaluations for hematologic disorders.
- Immunophenotyping is crucial for diagnosing and monitoring leukemia and lymphoma, complementing traditional morphology.
- Accurate interpretation of multi-parameter data requires robust standardization and validation.
Purpose of the Study:
- To review validation and quality control procedures for clinical flow cytometry services.
- To address the complexities of five- and six-parameter analyses in hematopathology.
- To ensure laboratory compliance with proficiency testing and method validation requirements.
Main Methods:
- Review of existing recommendations from NCCLS and the U.S.-Canadian Consensus Conference.
- Discussion of procedures for instrument, reagent, and procedural validation.
- Emphasis on documenting method accuracy, specificity, sensitivity, and precision.
Main Results:
- Standardization and validation are critical for complex flow cytometry analyses.
- Laboratories must validate their own qualitative and quantitative procedures.
- Proficiency testing and detailed documentation are regulatory requirements.
Conclusions:
- Comprehensive validation and quality control are essential for reliable clinical flow cytometry.
- Adherence to standardized procedures ensures accurate diagnosis and monitoring of hematopoietic malignancies.
- This paper provides a framework for validating all operational aspects of a clinical flow cytometry service.
Abstract:
Clinical flow cytometry has evolved from two-parameter quantitative assessment of peripheral blood lymphocytes to six-parameter qualitative evaluation of bone marrow for hematopathology. Leukemia and lymphoma immunophenotyping represent an extremely important complement to morphology in the diagnosis and monitoring of hematopoietic malignancies. The complexity of five- and six-parameter analyses and the interpretation of the data rely on standardization and validation of the instrument, the reagents and the procedure. In addition, flow cytometry laboratories in the U.S. are required to document proficiency testing, sample preparation, method accuracy, specificity, sensitivity and precision. NCCLS and the U.S.-Canadian Consensus Conference have provided recommendations, but each laboratory is ultimately responsible for validating its own qualitative and quantitative procedures. This paper reviews procedures for validation and quality control of all aspects of the operation of a clinical flow cytometry service.
