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A New Approach to Standardize Multicenter Studies: Mobile Lab Technology for the German Environmental Specimen Bank

机译：标准化多中心研究的新方法：德国环境标本库的移动实验室技术

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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 m2 reception area to record medical history and exposure-relevant behavior, a 21.1 m2 examination room to record dental fillings and for blood withdrawal, a 15.5 m2 biological safety level 2 laboratory to process and analyze samples on site including a 2.8 m2 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.
机译：技术进步简化了实验室诊断的任务，并提高了测试结果的质量。与在整个分析过程中遇到的错误相比，在分析前阶段发生的错误对测试结果质量的负面影响更大。采样地点的不同基础设施会极大地影响样品的质量以及分析结果。每年，德国环境标本银行（ESB）都会在德国的四个不同采样点收集，表征和存储120-150名志愿者的血液，血浆和尿液样本。总体目标是结合人类生物监测和问卷数据，调查非职业接触的年轻人对环境污染物的接触。我们调查了这项研究的要求以及在移动平台上实现高度标准化的采样程序的可能性，以提高分析前阶段所需的质量。结果导致在“ Labor der Zukunft”（未来的实验室技术）项目中开发了移动流行病学实验室（epiLab）。该实验室包括一个14.7 m 2 接待区，用于记录病史和与暴露相关的行为；一个21.1 m 2 检查室，用于记录牙科充填和采血；一个15.5 m 2 2级生物安全实验室，可现场处理和分析样品，包括2.8 m 2 人员锁和3.6 m 2 低温设施冻结样品。冷冻样品可以在不破坏冷链的情况下转移到车辆内的最终目的地。据我们所知，我们在此首次描述了在单个移动平台上实施生物安全实验室（BSL）2实验室和流行病学部门的方法。自2013年以来，我们每年都使用移动实验室在高度标准化的条件下收集多达15.000个人体样本。由于具有特征且没有任何改动，它们随时准备在其最终档案文件中，即德国ESB中进行追溯分析。

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