本文件涵盖了分析前阶段，并建议处理、记录和处理用于代谢组学分析的尿液、静脉血浆和血清。 本文件适用于代谢组学检查，对生物医学实验室、实验室客户、体外诊断开发商和制造商、进行生物医学研究的机构和公司、生物银行和监管机构具有重要意义。在分析前阶段采用所描述的程序使得比较和评估从代谢谱分析获得的结果成为可能。 注:国际、国家或地区法规或要求也可适用于本文件所涵盖的特定主题。

This document specifies requirements and gives recommendations for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.