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

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

Dominik Lermen  1 , Daniel Schmitt  2 , Martina Bartel-Steinbach  1 , Christa Schröter-Kermani  3 , Marike Kolossa-Gehring  3 , Hagen von Briesen  1 , Heiko Zimmermann  4
Affiliations

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

Dominik Lermen et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: Dominik Lermen, Daniel Schmitt, Martina Bartel-Steinbach and Heiko Zimmermann are with Fraunhofer IBMT. Fraunhofer IBMT is a non-for-profit research institute of the Fraunhofer-Society in Germany. The mobile laboratory has been conceptually designed by Fraunhofer IBMT and was tailored to the needs and plans of Fraunhofer IBMT in the framework of a research project funded by German federal state Saarland. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. General layout and concept of the mobile epidemiologic laboratory (epiLab).
Three motoric driven expansion units provide a reception and counseling area (14.5 m2) and an examination room (21.1 m2). The laboratory block (15.5 m2) has three rooms (personnel lock, BSL-2 lab and sample repository) with individual pressure levels for secure operation.
Figure 2
Figure 2. Mobile epiLab at first mission.
A: The expandable unit. B: View to the examination room. C: BSL-2 area in the mobile epiLab with urine processing area (background) and blood processing area (foreground).
Figure 3
Figure 3. Sample workflow and pre-analytics in the mobile epiLab.
Urine and blood samples are processed at the same time and aliquots are stored in the mobile cryo-repository and prepared for off-site analytics. Urine and plasma samples are also analyzed on-site.
Figure 4
Figure 4. Schematic workflow for the processing of urine (yellow), blood (red) and plasma (pink) samples in the mobile epiLab.
Three volunteers per 20 min are assumed for the optimum throughput shown here. The starting delay for the blood processing is caused by the on-site blood draw.
See this image and copyright information in PMC

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Publication types

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.

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