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Current status of liver function tests in Japan.
N Tatsumi1, M Hino, H Nakamura
1Department of Clinical and Laboratory Medicine, Osaka City University Medical School, Japan.
Summary
Inter-laboratory variations in liver function tests in Japan were assessed. While some tests like bilirubin, AST, and ALT showed acceptable variation, others like enzymes had higher variability, necessitating standardization for reliable laboratory data.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biochemistry
Background:
- Inter-laboratory variations can impact the reliability of health surveillance data.
- Standardization of laboratory testing is crucial for accurate diagnostic and monitoring purposes.
Purpose of the Study:
- To evaluate inter-laboratory variations in liver function tests and hepatitis markers in Japan.
- To identify specific laboratory parameters with significant variability.
- To assess the need for standardization in Japanese laboratory medicine.
Main Methods:
- Analysis of inter-laboratory coefficients of variation (CV) for various liver function tests.
- Evaluation of hepatitis markers detection rates.
- Comparison of results across different reagents and methods.
Main Results:
- Coefficients of variation for total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) were below 10%, indicating acceptable variability.
- Higher inter-laboratory variations were observed for other enzyme assays (gamma-GT, CHE, LD, ALP).
- Hepatitis marker detection was found to be acceptable across laboratories.
Conclusions:
- Despite acceptable variation in some liver function tests, significant variability exists for other enzyme assays.
- Differences in reagents and methods contribute to variations even for parameters with lower inter-laboratory CV.
- Standardization of laboratory data in Japan is essential and will support international standardization efforts in laboratory medicine.