Abstract
Human biomonitoring (HBM) programs consist of several interrelated and equally important steps. Of these steps, the study design must answer a specific question: How many individuals must be recruited in order to define the spatial or temporal trends of exposure to environmental pollutants in a given HBM study? Two components must be considered at this stage: the population variability of the expected exposure and the performance characteristics of the analytical methods used. The objective of the present study was to quantify the contribution to the required sample size arising from (i) measurement uncertainty and (ii) inter-laboratory measurement variability. For this purpose, the sample size was calculated using the measurement uncertainty of one laboratory, inter-laboratory comparison exercise data, and population variability for commonly studied metals (mercury, cadmium, and lead) in blood. Measurement uncertainty within one laboratory proved to have little influence on the sample size requirements, while the inter-laboratory variability of the three metals increased the requirements considerably, particularly in cases of low population variability. The multiple laboratories approach requires that laboratory variability be considered as early as the planning stage; a single-laboratory approach is thus a cost-effective compromise in HBM to reduce variability due to the participation of different laboratories.
Highlights
Human biomonitoring (HBM) studies are an effective tool to assess human exposure to environmental pollutants and the potential health effects of such pollutants, and are applied worldwide at the national and regional levels
The multiple laboratories approach requires that laboratory variability be considered as early as the planning stage; a single-laboratory approach is a cost-effective compromise in HBM to reduce variability due to the participation of different laboratories
The participants in the inter-laboratory comparison (ILC) exercises were asked to analyze all elements using their validated methodology intended for the HBM case study
Summary
Human biomonitoring (HBM) studies are an effective tool to assess human exposure to environmental pollutants and the potential health effects of such pollutants, and are applied worldwide at the national and regional levels. Recently has it been recognized that harmonized approaches are needed, including support activities, to guarantee the acquisition of comparable results. Different population groups are recruited using different protocols and recruitment strategies, making it impossible to compare results or conduct comparable health risk assessments. DEMOCOPHES study was the first attempt to perform harmonized HBM on an European scale, from the study design and protocols to the laboratory measurements and data analysis [1,2]. The ongoing European HBM Initiative HBM4EU is developing harmonized approaches for HBM in Europe, and has recognized trace elements cadmium (Cd), lead (Pb), and mercury (Hg) as priority substances in these HBM activities (https://www.hbm4eu.eu/). The Minamata Convention on Mercury was recently ratified, with the aim of protecting human health and the environment from the adverse effects of Hg (www.mercuryconvention.org).
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