1 Environmental Medicine, Department of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU2 Clinical Pharmacology and Pharmacy, Department of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU3 Ruhr University Bochum4 Environmental Toxicology, CNSA, Institute of Health Carlos III - (ISCIII), Madrid, Spain.5 KU Leuven, Belgium.6 Umweltbundesamt (UBA), Germany.7 University of Antwerp8 Public Health England, United Kingdom.9 Environmental Health Sciences International, The Netherlands.10 Jožef Stefan Institute, Slovenia.11 AU Studier - Uddannelseskvalitet og studienævnsbetjening (SNUK), AR12 BiPRO, Germany.13 Federal Public Service Health, Food Chain Safety and Environment, Belgium.14 State General Laboratory, Cyprus.15 National Institute of Public Health, Czech Republic.16 National Institute of Environmental Health, Hungary.17 National Labour Office, Department for Occupational Health, Hungary.18 Centre de Recherche Public - Gabriel Lippmann, Luxembourg.19 Laboratoire National de Santé, Luxembourg.20 Nofer Institute of Occupational Medicine, Poland.21 Faculdade de Medicina, Universidade de Lisboa, Portugal.22 Environmental Health Center, Romania.23 Urad Verejneho, Zdravotnictva Slovenskej Republiky, Slovakia.24 Karolinska Institutet, Sweden.25 Lund University Hospital26 Federal Office of Public Health (FOPH), Switzerland.27 unknown28 Public Analyst's Laboratory Galway, Ireland.29 Public Analyst's Laboratory Dublin, Ireland.30 Scientific Institute of Public Health, Belgium.31 Flemish Institute for Technological Research (VITO), Belgium.32 Environmental Medicine, Department of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU
Towards transnational comparability and reliability of human biomonitoring results
COPHES/DEMOCOPHES has its origins in the European Environment and Health Action Plan of 2004 to "develop a coherent approach on human biomonitoring (HBM) in Europe". Within this twin-project it was targeted to collect specimens from 120 mother-child-pairs in each of the 17 participating European countries. These specimens were investigated for six biomarkers (mercury in hair; creatinine, cotinine, cadmium, phthalate metabolites and bisphenol A in urine). The results for mercury in hair are described in a separate paper. Each participating member state was requested to contract laboratories, for capacity building reasons ideally within its borders, carrying out the chemical analyses. To ensure comparability of analytical data a Quality Assurance Unit (QAU) was established which provided the participating laboratories with standard operating procedures (SOP) and with control material. This material was specially prepared from native, non-spiked, pooled urine samples and was tested for homogeneity and stability. Four external quality assessment exercises were carried out. Highly esteemed laboratories from all over the world served as reference laboratories. Web conferences after each external quality assessment exercise functioned as a new and effective tool to improve analytical performance, to build capacity and to educate less experienced laboratories. Of the 38 laboratories participating in the quality assurance exercises 14 laboratories qualified for cadmium, 14 for creatinine, 9 for cotinine, 7 for phthalate metabolites and 5 for bisphenol A in urine. In the last of the four external quality assessment exercises the laboratories that qualified for DEMOCOPHES performed the determinations in urine with relative standard deviations (low/high concentration) of 18.0/2.1% for cotinine, 14.8/5.1% for cadmium, 4.7/3.4% for creatinine. Relative standard deviations for the newly emerging biomarkers were higher, with values between 13.5 and 20.5% for bisphenol A and between 18.9 and 45.3% for the phthalate metabolites. Plausibility control of the HBM results of all participating countries disclosed analytical shortcomings in the determination of Cd when using certain ICP/MS methods. Results were corrected by reanalyzes. The COPHES/DEMOCOPHES project for the first time succeeded in performing a harmonized pan-European HBM project. All data raised have to be regarded as utmost reliable according to the highest international state of the art, since highly renowned laboratories functioned as reference laboratories. The procedure described here, that has shown its success, can be used as a blueprint for future transnational, multicentre HBM projects.
International Journal of Hygiene and Environmental Health, 2014, Vol 217, Issue 6, p. 653-661