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

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.