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作废 CEN/TS 16945:2016
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma 分子体外诊断检查 - 尿液 静脉血清和血浆中代谢组学检查过程的规格
发布日期: 2016-05-18
废止日期: 2021-06-02
本技术规范涵盖了分析前阶段,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。该技术规范适用于代谢组学检查,对生物医学实验室,实验室客户,体外诊断开发人员以及执行生物医学研究,生物工程和监管机构的制造商,机构和公司来说都是重要的。 通过对分析前阶段的描述方法的采用,可以比较和评估从代谢分析分析获得的结果
This Technical Specification covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. This Technical Specification is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis.
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归口单位: CEN/TC 140
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