title: Requirements for reproducibility, trueness and error of measurement in internal quality control schemes.
abstract: Among the various models proposed to meet requirements for metrological performance in clinical laboratory measurements, that most widely used is intra- and inter-biological variation. However, this model has weaknesses: a) in some cases, intra-individual biological variation is so small that requirements based on such data may not be met by routine methods; b) there is great variation among the intra- and inter-individual biological variations themselves. We therefore propose integration between "state-of-the-art" methods to minimize imprecision, and also suggest that requirements calculated on the basis of biological variations should be used in setting requirements for minimizing imprecision. Furthermore, we describe a new scale for setting requirements from biological variation data and suggest that systematic error should be corrected whenever it is statistically significant.
authors.affiliation: Servizio di Medicina di Laboratorio, Azienda Ospedaliera, Padova, Italy. bonvi@protec.it
authors.forename: Piero
authors.initials: P
authors.lastname: Bonvicini
authors.forename: Paolo
authors.initials: P
authors.lastname: Metus
authors.forename: Maria A
authors.initials: MA
authors.lastname: Pavón
authors.forename: Massimo
authors.initials: M
authors.lastname: Tocchini
mesh_terms: D015982:Bias; D019411:Clinical Laboratory Techniques / Q000592:standards*; D015233:Models, Statistical; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results