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Feasibility evaluation of big data algorithms for establishing serum protein electrophoresis reference intervals
Chaochao Ma1, Lihua Guan2, Pengchang Li2
1Department of Laboratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing 100730, China; Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.
This study establishes sex-specific reference intervals (RIs) for serum protein electrophoresis (SPE) using large datasets and novel algorithms. The findings underscore the importance of tailored RIs for accurate clinical diagnosis.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biostatistics
Background:
- Serum protein electrophoresis (SPE) is crucial for diagnosing monoclonal gammopathies and other conditions.
- A lack of large-scale reference intervals (RIs) for SPE parameters hinders accurate diagnosis.
- This study addresses the need for robust, sex-specific RIs.
Purpose of the Study:
- To establish sex-specific RIs for SPE parameters using the Hoffmann and refineR algorithms.
- To assess the feasibility and reliability of these algorithms for generating customized RIs.
- To compare newly derived RIs with existing data.
Main Methods:
- Utilized two large health check-up population databases for reference and validation sets (n=52,293).
- Applied outlier removal (Tukey method) and variance component analysis to assess sex and age impacts.
- Employed Hoffmann and refineR algorithms to derive RIs, validated against independent data.
Main Results:
- Established sex-specific RIs with high consistency between Hoffmann and refineR algorithms.
- Identified significant sex differences in RIs for α2-globulin, β2-globulin, γ-globulin, and Albumin.
- Validated RIs demonstrated reliability, with minor exceptions for specific parameters in refineR analysis.
Conclusions:
- Sex significantly impacts SPE RIs, necessitating sex-specific intervals for clinical accuracy.
- The Hoffmann and refineR algorithms are effective and feasible for generating customized SPE RIs.
- Tailored RIs are essential for diverse clinical settings and improved diagnostic outcomes.
