Abstract
Objectives
The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) have established a program of work to make available, and to enable delivery of well characterized data describing the biological variation (BV) of clinically important measurands. Guided by the EFLM work the study presented here delivers BV estimates obtained from Chinese subjects for 32 measurands in serum.
Methods
Samples were drawn from 48 healthy volunteers (26 males, 22 females; age range, 21–45 years) for 5 consecutive weeks at Chinese laboratory. Sera were stored at −80 °C before triplicate analysis of all samples on a Cobas 8000 modular analyzer series. Outlier and homogeneity analyses were performed, followed by CV-ANOVA, to determine BV estimates with confidence intervals.
Results
The within-subject biological variation (CVI) estimates for 30 of the 32 measurands studied, were lower than listed on the EFLM database; the exceptions were alanine aminotransferase (ALT), lipoprotein (a) (LP(a)). Most of the between-subject biological variation (CVG) estimates were lower than the EFLM database entries.
Conclusions
This study delivers BV data for a Chinese population to supplement the EFLM BV database. Population differences may have an impact on applications of BV Data.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: This study was approved by the Ethics Committee of Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China (No. S – 2020–051).
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-0928).
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