Measurement performance goals: How they can be estimated and a view to managing them

Abstract Results of measurements of quantities in laboratory medicine are used for diagnosis, prediction and monitoring of disease. Evaluation of results is based on evidence and practical experience. In both cases consistency and transferability of results is needed. For diagnosis and prediction a result is compared to a reference value or reference interval whereas in monitoring it is more important to compare results of measurements with previous results. The analytical goals may therefore vary depending on the intended use of the results and both trueness and precision will need to be considered. The analytical goals may also be influenced by the disease characteristics. A brief review of available methods and principles will be given.

[1]  B H Ginsberg,et al.  A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. , 2000, Diabetes care.

[2]  George G Klee,et al.  Establishment of outcome-related analytic performance goals. , 2010, Clinical chemistry.

[3]  F. Sunderman,et al.  A survey of the accuracy of chemical analyses in clinical laboratories. , 1947, Manitoba medical review.

[4]  M. Hamilton,et al.  Measurement in Medicine , 1952, Nature.

[5]  D. B. Tonks,et al.  A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. , 1963, Clinical chemistry.

[6]  L A Kaplan,et al.  Determination and application of desirable analytical performance goals: the ISO/TC 212 approach. , 1999, Scandinavian journal of clinical and laboratory investigation.

[7]  Callum G. Fraser,et al.  Biological Variation: From Principles to Practice , 2001 .

[8]  C G Fraser,et al.  The application of theoretical goals based on biological variation data in proficiency testing. , 1988, Archives of pathology & laboratory medicine.

[9]  R. Gräsbeck The evolution of the reference value concept , 2004, Clinical chemistry and laboratory medicine.

[10]  P. H. Petersen,et al.  Analytical performance characteristics should be judged against objective quality specifications. , 1999, Clinical chemistry.

[11]  E. King,et al.  Normal values for blood constituents; inter-hospital differences. , 1953, Lancet.

[12]  G. Klee,et al.  [Establishment of outcome-related analytic performance goals]. , 2011, Annales de biologie clinique.

[13]  I. Wootton International Biochemical Trial 1954. , 1956, Clinical Chemistry.

[14]  D. Cox,et al.  Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose , 1987, Diabetes Care.

[15]  C Ricós,et al.  Current databases on biological variation: pros, cons and progress. , 1999, Scandinavian journal of clinical and laboratory investigation.