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

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.