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Non-linearity in commercially available lipase assays: still gaps to close

In 2016, Vogel et al. reported about the non-linearity within the primary measurement range of lipase assays, in which a discontinuity of results between 300 and 400 U/L was described [1]. The remarkable data were ascribed to a non-linearity of the Roche colorimetric lipase assay. To overcome this non-linearity, Roche Diagnostics changed their lipase application. In a first attempt, they changed the dilution from 1:10 to 1:2 for lipase activities >300 U/L. More recently, sample volume and assay points were adapted, together with a backswitch to a 1:10 dilution in decreased mode, because of improved linearity in the higher measuring range (see Table 1) [2]. In line with the paper by Vogel et al., we investigated the cumulative frequency of all lipase results in our lab information system (inpatients and outpatients), filtered on the result range of interest for this study (200–900 U/L for Roche assays). Results obtained with the most recent Roche Cobas 8000 c502 lipase application (in the period 01/05/2018–25/01/2019) are presented in Figure 1E.