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Ann Lab Med. 2020 May;40(3):201-208. English. Original Article. https://doi.org/10.3343/alm.2020.40.3.201
Cho J , Seo DM , Uh Y .
Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea. u931018@yonsei.ac.kr
Department of Medical Information, Yonsei University Wonju College of Medicine, Wonju, Korea.
Abstract

Background

Interpretation of changes in serial laboratory results is necessary for both clinicians and laboratories; however, setting decision limits is not easy. Although the reference change value (RCV) has been widely used for auto-verification, it has limitations in clinical settings. We introduce the concept of overlapping confidence intervals (CIs) to determine whether the changes are statistically significant in clinical chemistry laboratory test results.

Methods

In total, 1,202,096 paired results for 33 analytes routinely tested in our clinical chemistry laboratory were analyzed. The distributions of delta% absolute values and cut-off values for certain percentiles were calculated. The CIs for each analyte were set based on biological variation, and data were analyzed at various confidence levels. Additionally, we analyzed the data using RCVs and compared their clinical utility.

Results

Most analytes had low indexes of individuality with large inter-individual variability. The 97.5th percentile cut-offs for each analyte were much larger than conventional RCVs. The percentages of results exceeding RCV(95%) and RCV(99%) corresponded to those with no overlap at the 83.4% and 93.2% confidence levels, respectively.

Conclusions

The use of overlapping CIs in serial clinical chemistry test results can overcome the limitations of existing RCVs and replace them, especially for analytes with large intra-individual variation.

Copyright © 2019. Korean Association of Medical Journal Editors.