Guide to the expression of uncertainty of measurement: point/counterpoint.
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With great interest I read the “Point/Counterpoint” articles by Drs. Krouwer (1) and Kristiansen(2). In this regard, I would like to raise three issues: two analytical and one clinical.
With respect to the first analytical issue: laboratory experts and external quality assurance system organizers advocate that laboratory measurements be highly accurate, i.e., unbiased and precise. Although manufacturers of routine measurement procedures are usually able to solve most of the problems of imprecision, they are often unable to solve problems related to measurement bias. In my opinion, these Point/Counterpoint articles put undue pressure on the manufacturers to “improve the quality of their products”. The professionals in laboratory medicine should provide guidance to the manufacturers to help solve the problems of accuracy in a fair and transparent manner.
Quantities measured or determined in laboratory medicine are now divided into two categories: (A) those …
[1] Jan S Krouwer,et al. Critique of the Guide to the expression of uncertainty in measurement method of estimating and reporting uncertainty in diagnostic assays. , 2003, Clinical chemistry.
[2] Jesper Kristiansen,et al. The Guide to expression of uncertainty in measurement approach for estimating uncertainty: an appraisal. , 2003, Clinical chemistry.
[3] Leonard Steinborn,et al. International Organization for Standardization ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories , 2004 .