Trueness verification in European external quality assessment schemes: time to care about the quality of the samples

Abstract

An external quality assessment (EQA) survey on 14 fresh‐frozen, single‐donation sera assigned with reference measurement procedure (RMP) values revealed a mean bias of +5.2% and +3.7% for the cholesterol oxidase and the photometric glucose oxidase procedure groups, respectively. Conversely, on lyophilized sera, the same procedure groups showed almost bias‐free results, the differences from the RMP values being only −0.8% for cholesterol and +0.7% for glucose. These data, which are in fairly good agreement with the literature, suggest the existence of artificial matrix effects in processed materials. Therefore they indicate that, currently, assessment of trueness is hampered in many European EQA schemes, as most of them use lyophilized sera. This approach may give a false impression about the trueness of laboratory results as well as carrying the risk that laboratories calibrated on the RMP values of the survey samples could make errors in patient testing. Consequently, if European EQA is willing to fulfil a post‐market vigilance function of the performance of in vitro diagnostic medical devices, then the time has come to tackle the problem of the quality of the survey samples. EQA organizers urgently need to make an effort to seek out materials that analytically behave like authentic clinical specimens. In the meantime, alternative approaches should be used. Although not ideal, the special survey described in this article is one of the possibilities. Naturally, it implies logistic problems and increased costs for the individual EQA schemes. However, both can be overcome with the cooperation of the predominantly nationally organized schemes.

• Artificial matrix effect
• cholesterol
• fresh‐frozen
• glucose
• lyophilized sera
• reference measurement procedure values
• single‐donation sera
• trueness assessment