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Establishment and Validation of Serum Ferritin Reference Intervals Based on Real-World Big Data and Multi-Strategy
Yixin Xu1,2,3, Xiaojuan Wu1,2, Junlong Zhang1,2,3
1Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.
Journal of Clinical Medicine
|February 13, 2026
Summary
This study established new, accurate reference intervals for serum ferritin (SF) in a local population, improving diagnostic precision. The derived intervals, specific to sex and age, significantly outperformed manufacturer-provided ranges.
Area of Science:
- Clinical Chemistry
- Biomarker Reference Intervals
- Population Health Studies
Background:
- Establishing accurate population-based reference intervals (RIs) is crucial for interpreting laboratory test results.
- Existing serum ferritin (SF) RIs may not accurately reflect diverse populations or be optimized for specific analytical platforms.
- An indirect, data-driven approach using real-world laboratory data offers a method for RI determination and optimization.
Purpose of the Study:
- To establish and validate population-based reference intervals (RIs) for serum ferritin (SF) using an indirect, date-driven approach.
- To optimize partitioning strategies for SF RIs based on sex and age.
- To compare the performance of study-derived RIs against manufacturer-provided RIs.
Main Methods:
- Retrospective analysis of SF results from 29,723 apparently healthy individuals.
- Utilized Roche Cobas e801 platform for SF measurement.
- Employed Box-Cox transformation, iterative Tukey outlier removal, and decision tree regression for data-driven age cut-points.
- Estimated RIs using nonparametric percentile methods and validated in an independent cohort.
Main Results:
- SF concentrations were significantly higher in males than females (p < 0.001).
- In females, SF positively correlated with age (r = 0.466, p < 0.001), with 50 years identified as an optimal age cut-off.
- Study-derived RIs (Males: 98.02-997.78 µg/L; Females ≤50: 10.30-299.55 µg/L; Females >50: 36.61-507.00 µg/L) showed significantly higher validation pass rates than manufacturer RIs (p < 0.001).
Conclusions:
- Robust, sex- and age-specific SF RIs were established for the local population on the Roche Cobas e801 platform.
- The indirect, multi-step partitioning strategy proved effective for RI determination.
- This framework offers a reproducible and generalizable method for establishing RIs for other biomarkers.
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