The influence of analytical bias on diagnostic misclassifications

Clinica Chimica Acta; International Journal of Clinical Chemistry
P H PetersenM Hørder

Abstract

Quality specifications for analytical imprecision and bias based on the state of the art; 'biology' and 'analysis of clinical situations' have been proposed by several scientists. Most interesting is the assessment of 'diagnostic misclassifications' based on direct evaluation of the consequences of analytical bias on the percentage of false positives and false negatives from a clinical decision situation, or based on the percentage of healthy individuals outside each reference limit when common reference intervals are used. With use of graphical or computer simulations assuming increasing (positive or negative) analytical bias, the expected percentage of misclassifications can be estimated- and, for the error for which the outcome (the fraction of misclassifications) is considered unacceptable, the maximum allowable analytical bias can be defined. An overview is given of previous proposals for specification of allowable analytical bias, and new examples are presented: (i) for S-transferrin. an analytical bias of +10% will increase the percentage of healthy individuals with measured concentration values above the upper reference limit from 2.5 to 10% (ii) the percentage of healthy men with concentration values for S-cholesterol ...Continue Reading

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Citations

Apr 12, 2005·Clinica Chimica Acta; International Journal of Clinical Chemistry·M Panteghini, J C Forest
May 23, 2001·Clinica Chimica Acta; International Journal of Clinical Chemistry·C G Fraser
Feb 19, 1999·Clinica Chimica Acta; International Journal of Clinical Chemistry·P McNairJ Talmon
Mar 25, 1999·Clinica Chimica Acta; International Journal of Clinical Chemistry·A Waise
Apr 29, 1999·Clinical Chemistry and Laboratory Medicine : CCLM·C G Fraser
Jul 27, 1999·Clinical Chemistry and Laboratory Medicine : CCLM·F E von EybenE L Madsen
Sep 15, 2000·Clinical Chemistry and Laboratory Medicine : CCLM·P H PetersenH Goldschmidt
Aug 26, 2004·Clinical Chemistry and Laboratory Medicine : CCLM·Robert F Ritchie, Glenn Palomaki
Apr 6, 2007·Clinica Chimica Acta; International Journal of Clinical Chemistry·Catharine M Sturgeon, Andrew R Ellis
Jul 25, 2012·International Journal of Laboratory Hematology·E CornetX Troussard
Dec 9, 2014·Bioanalysis·Elvar TheodorssonIvo Leito
Sep 29, 2015·Archives of Pathology & Laboratory Medicine·Martin H KrollStephen C Suffin
Jul 25, 2006·Clinica Chimica Acta; International Journal of Clinical Chemistry·Gian Cesare GuidiMario Plebani
Mar 30, 2010·Clinical Chemistry·George G Klee

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