There appears to be a growing debate with regard to the use of "Westgard style" total error and "GUM style" uncertainty in measurement. Some may argue that the two approaches are irreconcilable. The recent appearance of an article "Quality goals at the crossroads: growing, going, or gone" on the well-regarded Westgard Internet site requires some comment. In particular, a number of assertions which relate to ISO 15189 and uncertainty in measurement appear misleading. An alternate view of the key issues raised by Westergard may serve to guide and enlighten others who may accept such statements at face value.
Procedures for assessing the uncertainty in measurement and estimates of biological variation are currently available for many measurands capable of direct analytical measurement. However, not all measurands or quantity values determined in a medical laboratory are provided by direct analytical measurement. Estimated glomerular filtration rate (eGFR) is such a quantity value. In this situation, the result is calculated from other measurements through a functional relationship in which the output value (the calculated quantity value) is derived from one or more input quantities by applying a defined mathematical equation.The aims of this review are: to summarise the principal methods for assessing uncertainty in measurement in complicated non-linear expressions; and to describe an approach for estimating the uncertainty in measurement and biological variation of the Chronic Kidney Disease Epidemiology Collaboration equations for eGFR. In practice, either the direct application of the propagation of uncertainty in measurement equation or a Monte Carlo simulation procedure using a readily available spreadsheet may be used to evaluate uncertainty in measurement or the propagation of biological variation.If the only recognised “uncertainty” is the biological variation in the measured serum creatinine, the equation for the propagation of uncertainties in measurement for the eGFR simplifies to an expression in which the coefficient of variation of the eGFR (or the biological variation of the eGFR) is directly proportional to the coefficient of variation of the measured serum creatinine (or the biological variation of the serum creatinine).
The debate comparing the benefits of measurement uncertainty (uncertainty in measurement, MU) with total error (TE) for the assessment of laboratory performance continues. The summary recently provided in this journal by members of the Task and Finish Group on Total Error (TFG-TE) of the EFLM put the arguments into clear perspective. Even though there is generally strong support for TE in many laboratories, some of the arguments proposed for its on-going support require further comment. In a recent opinion which focused directly on the TFG-TE summary, several potentially confusing statements regarding ISO15189 and the Evaluation of measurement data - Guide to the expression of uncertainty in measurement (GUM) were again promulgated to promote TE methods for assessing uncertainty in laboratory measurement. In this opinion, we present an alternative view of the key issues and outline our views with regard to the relationship between ISO15189, uncertainty in measurement and the GUM.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.