Do new concepts for deriving permissible limits for analytical imprecision and bias have any advantages over existing consensus?

被引:11
作者
Petersen, Per Hyltoft [1 ]
Sandberg, Sverre [1 ,2 ]
Fraser, Callum G. [3 ]
机构
[1] Univ Bergen, Norwegian Qual Improvement Primary Care Labs, Div Gen Practice, NOKLUS, Bergen, Norway
[2] Haukeland Hosp, Lab Clin Biochem, N-5021 Bergen, Norway
[3] Scottish Bowel Screening Ctr Lab, Dundee, Scotland
关键词
analytical goals; analytical quality specifications; biological variation; clinical situations; hierarchy of specifications; medical opinions; EXTERNAL QUALITY ASSESSMENT; ANALYTICAL GOALS; LABORATORY MEDICINE; CLINICAL-CHEMISTRY; SPECIFICATIONS; STRATEGIES;
D O I
10.1515/CCLM.2011.117
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
The Stockholm conference held in 1999 on "Strategies to set global analytical quality specifications (AQS) in laboratory medicine" reached a consensus and advocated the ubiquitous application of a hierarchical structure of approaches to setting AQS. This approach has been widely used over the last decade, although several issues remain unanswered. A number of new suggestions have been recently proposed for setting AQS. One of these recommendations is described by Haeckel and Wosniok in this issue of Clinical Chemistry and Laboratory Medicine. Their concept is to estimate the increase in false-positive results using conventional population-based reference intervals, the delta false-positive rate due to analytical imprecision and bias, and relate the results directly to the current analytical quality attained. Thus, the actual estimates in the laboratory for imprecision and bias are compared to the AQS. These values are classified in a ranking system according to the closeness to the AQS, and this combination is the new idea of the proposal. Other new ideas have been proposed recently. We wait, with great interest, as should others, to see if these newer approaches become widely used and worthy of incorporation into the hierarchy.
引用
收藏
页码:637 / 640
页数:4
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