{"title":"[Mitigation Strategies and Evaluation Methods for Lipemia Interference in <i>In Vitro</i> Diagnostic Products].","authors":"Yurong Ji, Xiaofan Yin","doi":"10.12455/j.issn.1671-7104.250548","DOIUrl":null,"url":null,"abstract":"<p><p>Lipemia interference resistance constitutes a critical performance indicator in the design and development of <i>in vitro</i> diagnostic products. In this article, the causes of lipemic samples and their interference pathways are briefly introduced; currently available common strategies employed to counteract lipemia interference have been summarized, including widely accepted approaches such as ultracentrifugation and sample dilution, as well as recently implemented techniques like reagent formulation modification and measurement procedure optimization. Furthermore, based on the requirements outlined in the latest publication of the Clinical and Laboratory Standards Institute (CLSI) EP07 <i>Interference Testing in Clinical Chemistry</i> and the pharmaceutical industry standard of the People's Republic of China YY/T 1789.5 - 2023 <i>Performance Evaluation Methods for In Vitro Diagnostic Test Systems - Part 5: Analytical Specificity</i>, the standardized evaluation methods for lipemia interference are systematically discussed.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 5","pages":"584-590"},"PeriodicalIF":0.0000,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国医疗器械杂志","FirstCategoryId":"1087","ListUrlMain":"https://doi.org/10.12455/j.issn.1671-7104.250548","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
Lipemia interference resistance constitutes a critical performance indicator in the design and development of in vitro diagnostic products. In this article, the causes of lipemic samples and their interference pathways are briefly introduced; currently available common strategies employed to counteract lipemia interference have been summarized, including widely accepted approaches such as ultracentrifugation and sample dilution, as well as recently implemented techniques like reagent formulation modification and measurement procedure optimization. Furthermore, based on the requirements outlined in the latest publication of the Clinical and Laboratory Standards Institute (CLSI) EP07 Interference Testing in Clinical Chemistry and the pharmaceutical industry standard of the People's Republic of China YY/T 1789.5 - 2023 Performance Evaluation Methods for In Vitro Diagnostic Test Systems - Part 5: Analytical Specificity, the standardized evaluation methods for lipemia interference are systematically discussed.
期刊介绍：
Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.
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