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A global multicenter study on reference values: 1. Assessment of methods for derivation and comparison of reference
Kiyoshi Ichihara1, Yesim Ozarda2, Julian H Barth3
1Faculty of Health Sciences, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Clinica Chimica Acta; International Journal of Clinical Chemistry
|September 27, 2016
Summary
This global study harmonized reference interval (RI) derivation methods, revealing that the latent abnormal values exclusion (LAVE) method effectively identifies variations in analytes reflecting nutritional status and inflammation. Findings confirm the parametric method
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biostatistics
Background:
- Establishing accurate reference intervals (RIs) is crucial for clinical decision-making.
- Global variations in reference values (RVs) necessitate harmonized derivation procedures.
- The IFCC Committee on Reference Intervals and Decision Limits initiated a multicenter study to address these challenges.
Purpose of the Study:
- To explore rational and harmonizable procedures for deriving reference intervals (RIs).
- To investigate the feasibility of sharing RIs globally by evaluating sources of variation in RVs.
- To assess the effectiveness of the latent abnormal values exclusion (LAVE) method in harmonized recruitment.
Main Methods:
- A global multicenter study involving 13,386 healthy adults across 12 countries.
- Measurement of 50 analytes (25 chemical, 25 immunological) using a common protocol.
- Application of parametric and nonparametric methods for RI derivation, including the LAVE method and modified Box-Cox transformation.
Main Results:
- The LAVE method highlighted frequent inappropriate results for analytes related to nutritional status, inflammation, and muscular exertion.
- The parametric method's validity was confirmed through successful Gaussian transformation across all participating countries.
- Nearly half of the analytes exhibited between-country differences in RVs, requiring further adjustment for factors like BMI.
Conclusions:
- The collaborative study successfully evaluated rational methods for deriving RIs.
- Harmonized data collection enabled effective comparison of RVs across different countries.
- Findings support the development of more globally applicable reference intervals.
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