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Leukocyte immunophenotyping by flow cytometry in a multisite study: standardization, quality control, and normal
J W Parker1, B Adelsberg, S P Azen
1University of Southern California School of Medicine, Los Angeles 90032.
Clinical Immunology and Immunopathology
|May 1, 1990
Summary
The Transfusion Safety Study (TSS) standardized flow cytometry methods to ensure accurate results for transfusion-transmitted infections. This ensures reliable data for future research on transfusion safety.
Area of Science:
- Immunology
- Hematology
- Infectious Diseases
Background:
- The Transfusion Safety Study (TSS) investigates factors influencing transfusion-transmitted infections.
- Decentralized flow cytometry laboratories were established to maintain sample integrity.
- Standardization was crucial to ensure compatible and reliable results across centers.
Purpose of the Study:
- To document the standardization and quality control procedures for the TSS flow cytometry laboratory.
- To assess the impact of pre-analytical variables on antibody detection.
- To establish reference ranges for monoclonal antibodies used in the study.
Main Methods:
- Established six multicenter flow cytometry laboratories.
- Developed stringent standardization, quality control, and proficiency testing protocols.
- Analyzed the effects of time from phlebotomy to analysis and light scatter variations.
Main Results:
- Documented the impact of pre-analytical variables on antibody detection.
- Presented a robust quality control and data management system.
- Provided extensive age- and sex-related reference ranges for monoclonal antibodies.
Conclusions:
- Standardization and quality control are essential for reliable flow cytometry in multicenter studies.
- Established reference ranges will aid in interpreting future TSS data.
- This study provides a foundational reference for subsequent TSS publications on transfusion safety.