Article: The impact of variability in the risk of disease exemplified by diagnosing diabetes mellitus based on ADA and WHO criteria as gold standard Journal: International Journal of Risk Assessment and Management (IJRAM) 2005 Vol.5 No.2/3/4 pp.358 - 373 Abstract: The diagnosis of clinically mute diabetes mellitus (DM) is based on a nominal concentration of fasting peripheral venous plasma glucose (f-vPG) at ≥7.0mmol/l, to be exceeded by first and confirmatory measurement. Aim: to identify error sources in the clinical use of biochemical data, to use the diagnostic concept for clinically mute DM. Materials and methods: error contributors were established. We estimated the probability of f-vPG >7.0 as a function of the biological set point, and the biological variation (CV<SUB align="right"><SMALL>withinsubject</SMALL></SUB>=4.9%), the CLIA regulations and the ISO 15197 standard for total error (TE) (CLIA TE±10% and ISO 15197 TE±20%). Results: The probability of getting a single f-vPG measurement ≥7.0mmol/l as a function of the biological set-point, and the probability when introducing a ||confirmatory|| test was investigated, based on algorithms. Half of those with a biological set-point of 7.0 mmol/l are measured ≥7.0mmol/l, and half of those are confirmed diabetic. The effects of analytical error types are different and need careful distinction. Inderscience Publishers - linking academia, business and industry through research

Title: The impact of variability in the risk of disease exemplified by diagnosing diabetes mellitus based on ADA and WHO criteria as gold standard

Authors: Lone G.M. Jorgensen, Per Hyltoft Petersen, Ivan Brandslund

Addresses: The Laboratory Centre, Vejle County Hospital, DK-7100 Vejle, Denmark. ' Norwegian Centre for External Quality Assurance of Primary Care Laboratories, University of Bergen, Norway. ' Department of Clinical Biochemistry, Vejle County Hospital, DK-7100 Vejle, Denmark

Abstract: The diagnosis of clinically mute diabetes mellitus (DM) is based on a nominal concentration of fasting peripheral venous plasma glucose (f-vPG) at ≥7.0mmol/l, to be exceeded by first and confirmatory measurement. Aim: to identify error sources in the clinical use of biochemical data, to use the diagnostic concept for clinically mute DM. Materials and methods: error contributors were established. We estimated the probability of f-vPG >7.0 as a function of the biological set point, and the biological variation (CV_{withinsubject}=4.9%), the CLIA regulations and the ISO 15197 standard for total error (TE) (CLIA TE±10% and ISO 15197 TE±20%). Results: The probability of getting a single f-vPG measurement ≥7.0mmol/l as a function of the biological set-point, and the probability when introducing a ||confirmatory|| test was investigated, based on algorithms. Half of those with a biological set-point of 7.0 mmol/l are measured ≥7.0mmol/l, and half of those are confirmed diabetic. The effects of analytical error types are different and need careful distinction.

Keywords: bimodal distribution; diabetes mellitus; diagnostic guidelines; Gaussian distribution; incidence; prevalence; risk assessment; uncertainty; unimodal distribution; variability; disease risk; health risks; medical diagnosis; biochemical data; analytical error; biochemical measurements.

DOI: 10.1504/IJRAM.2005.007177

International Journal of Risk Assessment and Management, 2005 Vol.5 No.2/3/4, pp.358 - 373

Published online: 02 Jun 2005 *

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Title: The impact of variability in the risk of disease exemplified by diagnosing diabetes mellitus based on ADA and WHO criteria as gold standard

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