论文信息 - General strategies to set quality specifications for reliability performance characteristics.

General strategies to set quality specifications for reliability performance characteristics.

Many strategies have been promulgated for the setting of quality specifications in laboratory medicine. Based on the analysis of the effect of error on clinical decision making, general quality specifications for precision, bias, the allowable difference between two analytical methods, drugs, fixed limits for use in external quality assessment and reference methods seem best derived from components of biological variation.

C G Fraser | C. Fraser | Callum G. Fraser

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

[2] P. H. Petersen,et al. Desirable standards for laboratory tests if they are to fulfill medical needs. , 1993, Clinical chemistry.

[3] C G Fraser,et al. Quality goals in external quality assessment are best based on biology. , 1993, Scandinavian journal of clinical and laboratory investigation. Supplementum.

[4] Mogens Lytken Larsen,et al. A Comparison of Analytical Goals for Haemoglobin A1c Assays Derived Using Different Strategies , 1991, Annals of clinical biochemistry.

[5] Jean-Claude Libeer,et al. Proposals for Setting Generally Applicable Quality Goals Solely Based on Biology , 1997, Annals of clinical biochemistry.

[6] C G Fraser,et al. Desirable standards of performance for therapeutic drug monitoring. , 1987, Clinical chemistry.

[7] C. Fraser. Judgement on Analytical Quality Requirements from Published Clinical Vignette Studies Is Flawed , 1999, Clinical chemistry and laboratory medicine.