Proposals for setting generally applicable quality goals solely based on biology.
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Biomedical subjects
Publications and source records attributed to C Ricos.
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A questionnaire was circulated to European countries seeking information on the criteria used for acceptable performance in external quality assessment schemes. Responses were obtained from 21 countries. Fixed limits are used in 13 countries but the basis for these varies widely and includes clinical decision making, biological variation, views of experts, the state-of-the-art, and combinations of approaches. Variable limits based upon statistical analysis of the performance attained are used in 8 countries. The many advantages of harmonization in Europe have prompted the development of criteria based upon within- and between-subject biological variation for use in schemes which circulate single specimen challenges. Currently used criteria, which show much diversity, are compared with these proposals, and the empirical nature of the majority of the former is demonstrated.
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A Working Group of the European Group for the Evaluation of Reagents and Analytical Systems in Laboratory Medicine proposes, after detailed study of the advantages and disadvantages of available strategies, the following quality specifications for analytical systems for clinical chemistry. Total imprecision should be: (a) less than one-half of the average within-subject biological variation, or (b) less than the state of the art achieved by the best 0.20 fractile of laboratories, whichever is the less stringent. The second approach may be used when data on biological variation do not exist. Inaccuracy should be: (a) less than one-quarter of the group (within- plus between-subject) biological variation, or (b) less than one-sixteenth of the reference interval, when data on group biological variation do not exist, or (c) less than twice the ideal imprecision, if the above specifications are too demanding.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.