title: Pilot external quality assessment survey for post-market vigilance of in vitro diagnostic medical devices and investigation of trueness of participants' results.
abstract: The Czech External Quality Assessment Scheme organized a survey using 14 fresh-frozen sera targeted for cholesterol and glucose by reference measurement procedures. The objective was to investigate whether it could fulfil a post-market vigilance function for in vitro diagnostic medical devices and assess trueness of participants' results. It revealed a mean bias of +5.1% for cholesterol and +3.7% for glucose (n approximately 150). However, the bias source (manufacturer or laboratory) could not be identified unequivocally because of the lack of homogeneous groups. This was due to the fact that laboratories mainly used reagents from manufacturers that do not market instruments or combined calibrators and reagents from different sources. Consequently, these habits did not allow the survey to fulfil the vigilance function. On the other hand, we were able to show the individual participants results for patient samples deviating from the true value (deviations >10% in approximately 20% of the laboratories). However, again, the survey failed in problem-solving via peer-group evaluation, even for participants that applied homogeneous tests. If other European schemes confirm this outcome, cooperation and/or participation of manufacturers may be the solution. The survey pointed out to the other participants, interchanging instrument, reagent and calibrator, that they are themselves responsible for the problems shown and hence also for problem-solving.
authors.affiliation: Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Ghent University, Gent, Belgium. linda.thienpont@rug.ac.be
authors.forename: Linda M
authors.initials: LM
authors.lastname: Thienpont
authors.forename: Dietmar
authors.initials: D
authors.lastname: Stöckl
authors.forename: Josef
authors.initials: J
authors.lastname: Kratochvíla
authors.forename: Bedrich
authors.initials: B
authors.lastname: Friedecký
authors.forename: Marek
authors.initials: M
authors.lastname: Budina
mesh_terms: D001786:Blood Glucose / Q000096:biosynthesis; D002138:Calibration; D002624:Chemistry, Clinical / Q000379:methods*; D002784:Cholesterol / Q000097:blood; D019411:Clinical Laboratory Techniques; D019719:Diagnostic Equipment; D008401:Gas Chromatography-Mass Spectrometry / Q000379:methods*; D006801:Humans; D066298:In Vitro Techniques; D015588:Observer Variation; D010865:Pilot Projects; D011786:Quality Control; D012016:Reference Values; D015203:Reproducibility of Results
chemical_list: D001786:Blood Glucose; D002784:Cholesterol