Inderscience Publishers

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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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 (CVwithinsubject=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

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