(Download) "Point: Critique of the Guide to the Expression of Uncertainty in Measurement Method of Estimating and Reporting Uncertainty in Diagnostic Assays (Point/Counterpoint)" by Clinical Chemistry " eBook PDF Kindle ePub Free
eBook details
- Title: Point: Critique of the Guide to the Expression of Uncertainty in Measurement Method of Estimating and Reporting Uncertainty in Diagnostic Assays (Point/Counterpoint)
- Author : Clinical Chemistry
- Release Date : January 01, 2003
- Genre: Chemistry,Books,Science & Nature,
- Pages : * pages
- Size : 204 KB
Description
Accuracy, the closeness in agreement between a test result and an accepted reference method, is a concept well known to clinical chemists. Inaccuracy, the lack of closeness in agreement (also called total analytical error), is caused by random and systematic errors. The Guide to the Uncertainty of Measurement (1), hereafter referred to as GUM, provides a model for expressing uncertainty in measurement and is compared with other methods of estimating and reporting uncertainty. GUM was prepared by representatives from several national standards organizations (International Bureau of Weights and Measures, International Organization for Standardization, International Electrotechnical Commission, IUPAC, IFCC, and International Organization of Legal Metrology), which gives it weight as an international guideline. GUM is typically used to provide uncertainty statements for reference materials; an example is NIST 1951a: Lipids in Human Serum (2). GUM may affect how diagnostic assays are evaluated because of the implied authoritativeness of GUM and because diagnostic assays are regulated in many countries. As an example, the European Commission has published an example of the use of GUM for analysis of calcium and glucose in human serum (3, 4). Kristiansen (5) described how GUM applies to diagnostic assays. Here I will describe problems with the GUM method with respect to its use for routine diagnostic assays. Kallner (6) and the NIST web site (7) provide excellent descriptions of the GUM method. Grabe (8) has critiqued the GUM method. To briefly summarize the GUM approach, GUM considers random error and systematic error as the two possible sources of measurement error. The uncertainty of a measurement result stems from uncertainty attributable to random effects and from imperfect correction of systematic effects.
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