Objectives: Non-linearity in lipase assays and the ensuing gaps in results distribution have been described on Roche analysers, but have yet to be studied on other analysers.
Design And Methods: Eighteen lithium-heparinized plasma pools of lipase activities decreasing from 1700 to <4 U/L were prepared for multicentric evaluation on several analysers. Non-linearity was modelled as the difference between the polynomial regression of lipase activities depending on relative dilutions over the primary measuring range, and the linear regression of the same variables above the manufacturer's limit of linearity (MLL).