Nationwide multicenter study aimed at the establishment of common reference intervals for standardized clinical laboratory tests in Japan
-
Yoshikazu Yamamoto
,
Shigemi Hosogaya
Abstract
Background: The Japanese Association of Medical Technologists (JAMT) sought to establish common reference intervals (RIs) applicable nationwide in Japan for 27 serum constituent analytes for which certified reference materials are available and nine analytes frequently measured in routine tests. More than 100 laboratories certified for metrological traceability collaborated in the recruitment, sampling, and measurement of analytes for the establishment of RIs. No previous attempt has been made to establish RIs by such a large number of laboratories. The allowable limits of trueness and intermediate precision based on the JAMT criteria were applied to the reference values measured by these laboratories, and measured values within the allowance limits were used to establish RIs.
Methods: Reference individuals included 5748 healthy volunteers aged 18–65 years who were engaged in medical care-related work based on the CLSI guidelines. After secondary exclusion of individuals in whom abnormal values were detected in basic routine test items and adjustment for the distribution of age and gender, 3371 reference individuals were chosen in the parametric determination of RIs. Employing the three-level nested ANOVA, between-laboratory, -region, -sex, and -age variations were evaluated.
Results: No significant difference was noted in between-region variations in any item. Results of ANOVA revealed between-sex and -age variations in 14 and 15 analytes, respectively. Based on these results of variation, RIs were established with and without partition by sex.
Conclusions: Since no between-region variation was detected in reference values among accuracy-certified core laboratories, RIs applicable nationwide were established.
This project was planned by the Committee on Standardization of Clinical Laboratory Values of the Japanese Association of Medical Technologists. This project was supported by the JCCLS. We are grateful to the core laboratories, their staff (including staff blood donation), and the associated members of participating laboratories for their generous assistance.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
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- Editorial
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