体外诊断产品脂血干扰消除策略及评价方法

      Mitigation Strategies and Evaluation Methods for Lipemia Interference in In Vitro Diagnostic Products

      • 摘要: 抗脂血干扰性能是体外诊断产品设计开发过程的核心指标。该文简单介绍了脂血样本的产生原因及干扰途径;总结了目前公开的常见抗脂血干扰方法,包括广泛接受的超速离心、样本稀释,以及近年来逐渐应用的试剂配方调整、测量程序优化等;最后结合美国临床实验室标准化协会(CLSI)最新发表的EP07《临床化学中的干扰测试》及中华人民共和国医药行业标准YY/T 1789—2023《体外诊断检验系统 性能评价
        方法 第5部分:分析特异性》中的要求,讨论了脂血干扰标准化评价方法。

         

        Abstract: Lipemic interference resistance constitutes a critical focus in the design and development of in vitro diagnostic products. The causes of lipemic sample formation and their interference mechanisms are briefly introduced; currently available common strategies employed to counteract lipid interference have been summarized, including widely accepted techniques such as ultracentrifugation and sample dilution, as well as recently implemented approaches like reagent formulation modification and measurement procedure optimization. Furthermore, by incorporating recommendations from the Clinical and Laboratory Standards Institute (CLSI) EP07 document "Interference Testing in Clinical Chemistry" and the People's Republic of China YY/T 1789—2023 standard "In vitro diagnostic test systems - Performance evaluation methods - Part 5: Analytical specificity", standardized methodologies for assessing lipid interference are systematically discussed.

         

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