All you wanted to know about laboratory tests, but were afraid to ask By Dietmar Stöckl STT Consulting - 9 - The informed patient meeting the laboratory.

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All you wanted to know about laboratory tests, but were afraid to ask By Dietmar Stöckl STT Consulting The informed patient meeting the laboratory director Analytical Performance Goals

All you wanted to know about laboratory tests Today

All you wanted to know about laboratory tests -9- 3

4 The start First general limits Belk W, Sunderman FW. A survey of the accuracy of chemical analyses in clinical laboratories. Am J Clin Pathol 1947;17: (reprinted in: Arch Pathol Lab Med 1988;112:320-6). First goals based on biology Tonks DB. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin Chem 1963;9: % maximum total error (TE max ) = 100 * [¼ of the reference interval (RI)/mean of RI] “If the normal range for sodium is taken to be mEq./L., then the allowable limits of error calculated by this formula are ± 1.8%”. “The maximum limits for any determination, however, were set at ± 10%, even though in some cases those calculated by the above formula exceeded this figure”.

All you wanted to know about laboratory tests The concepts The discipline agreed on the hierarchy of models for establishing analytical performance goals# Clinical concepts Questionnaires to clinicians Concepts based on biological variation Expert opinion/Regulations "State-of-the-art" #Kenny D, Fraser CG, Hyltoft Petersen P, Kallner A. Strategies to set global quality specifications in laboratory medicine, Stockholm, April Consensus agreement. Scand J Clin Lab Invest 1999;59:585.

All you wanted to know about laboratory tests The reality Clinical concepts & questionnaires to clinicians Few data available Concepts based on biological variation Start getting used by industry; misconception: values are for the laboratory, industry should use more stringent goals Expert opinion/Regulations Highly variable "State-of-the-art“ Difficult to assess; information typically restricted to imprecision ( several essays on “Sigma analysis”)

All you wanted to know about laboratory tests The reality Typically, there is no consensus between (and often within) the different concepts TEa of serum sodium measurement SourceTEa (%) Biological variation (Ricos data, “Westgard page”) 0.9 ¼ of the reference-interval2.2 American EQA (CLIA) (in % mean of RI) 2.9 German EQA5

All you wanted to know about laboratory tests Resources Educational material > >Education General >Analytical quality II TSH example >Analytical performance goals TSH Performance goals from biology

All you wanted to know about laboratory tests I type... A lot to think about... more needs to be done.

All you wanted to know about laboratory tests The next visit See you next time. Performance assessment