A new approach to standardize multicenter studies: mobile lab technology for the German Environmental Specimen Bank

PLoS One. 2014 Aug 20;9(8):e105401. doi: 10.1371/journal.pone.0105401. eCollection 2014.

Abstract

Technical progress has simplified tasks in lab diagnosis and improved quality of test results. Errors occurring during the pre-analytical phase have more negative impact on the quality of test results than errors encountered during the total analytical process. Different infrastructures of sampling sites can highly influence the quality of samples and therewith of analytical results. Annually the German Environmental Specimen Bank (ESB) collects, characterizes, and stores blood, plasma, and urine samples of 120-150 volunteers each on four different sampling sites in Germany. Overarching goal is to investigate the exposure to environmental pollutants of non-occupational exposed young adults combining human biomonitoring with questionnaire data. We investigated the requirements of the study and the possibility to realize a highly standardized sampling procedure on a mobile platform in order to increase the required quality of the pre-analytical phase. The results lead to the development of a mobile epidemiologic laboratory (epiLab) in the project "Labor der Zukunft" (future's lab technology). This laboratory includes a 14.7 m(2) reception area to record medical history and exposure-relevant behavior, a 21.1 m(2) examination room to record dental fillings and for blood withdrawal, a 15.5 m(2) biological safety level 2 laboratory to process and analyze samples on site including a 2.8 m(2) personnel lock and a 3.6 m2 cryofacility to immediately freeze samples. Frozen samples can be transferred to their final destination within the vehicle without breaking the cold chain. To our knowledge, we herewith describe for the first time the implementation of a biological safety laboratory (BSL) 2 lab and an epidemiologic unit on a single mobile platform. Since 2013 we have been collecting up to 15.000 individual human samples annually under highly standardized conditions using the mobile laboratory. Characterized and free of alterations they are kept ready for retrospective analyses in their final archive, the German ESB.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biological Specimen Banks / standards*
  • Environment
  • Female
  • Germany
  • Humans
  • Male
  • Mobile Health Units*
  • Multicenter Studies as Topic / methods
  • Multicenter Studies as Topic / standards*

Grants and funding

DL and HvB received funding for the sampling from the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety. Grant Number: 301 02 048 http://www.bmub.bund.de/en/. DS and HZ received funding from the government and the State Chancellery of the federal state Saarland (Germany). Grant Number: C/1-LdZ-2011 http://www.saarland.de/staatskanzlei.htm. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.