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Quality control in flow cytometry for diagnostic pathology: II. A conspectus of reference ranges for lymphocyte
1Flow Cytometry Laboratory, Cooper Hospital/UMC, Camden, New Jersey.
Insights
Establishing standardized reference ranges for immunophenotyping is crucial for accurate clinical interpretation. This review addresses key variables and statistical methods for creating reliable reference values in flow cytometry.
Area of Science:
- Clinical Laboratory Science
- Immunology
- Flow Cytometry
Background:
- Immunophenotyping requires interpretation against reference values from healthy individuals.
- Standardization of reference range establishment in clinical flow cytometry is lacking.
- Current practices for obtaining, analyzing, and expressing reference values lack consensus.
Purpose of the Study:
- To review critical variables for establishing robust immunophenotyping reference ranges.
- To discuss statistical methodologies applicable to reference value determination.
- To provide examples of published reference ranges for common immunophenotyping specimens.
Main Methods:
- Literature review of factors influencing reference range establishment.
- Analysis of statistical approaches for reference value calculation.
- Compilation of existing reference range data for immunophenotyping.
Main Results:
- Identified key variables impacting reference range generation (e.g., specimen type, methodology).
- Highlighted various statistical methods suitable for reference value analysis.
- Presented examples of established reference ranges for diverse samples.
Conclusions:
- Standardized protocols are needed for reliable immunophenotyping reference ranges.
- Consistent methodology will improve inter-laboratory comparability and clinical decision-making.
- Further research and consensus are required to optimize reference range practices.
Abstract:
Immunophenotyping, as many other clinical assays, is interpreted only in the context of reference values obtained from healthy control individuals. While the use of these reference values, or ranges, has been commonplace in the clinical flow cytometry laboratory for well over a decade, there has been little consensus in standardizing how these values should be obtained, analyzed, or expressed. This report reviews the variables to be considered in establishing reference ranges and statistical methods which can be used. Additionally, examples are given of previously published reference ranges for a variety of specimens often submitted for immunophenotyping.
