Table 1.

Settings for simulation of five analytes.a

AlbuminHbA1cTestosteroneTroponin IVitamin D3
DescriptionMany measurements per day; normal distribution of true valuesLow sigma value; four QC measurementsBimodal distribution of true values based on sexMany measurements close to limit of detectionSeasonal variation of true values
Measurements per day (SD)500 (50)70 (6)Male: 50 (5) Female: 30 (4)120 (20)200 (20)
Distribution of valuesNormal; centerb: 3.474 spread: 0.886 (unit: g/dl)Lognormal; center: 5.504 spread: 0.892 (unit: %)Male: lognormal; center: 3.505 spread: 2.402 female: lognormal; center: 0.366 spread: 0.532 (unit: ng/mL)Lognormal; center: 0.160 spread: 0.656 (unit: ng/mL)Lognormal; center: 19.585 ± 7.5% seasonal variation; spread: 11.382 (unit: ng/mL)
Allowable total error [on interval]12.5% [2–7]10% [4.89– 14.96]20.5% [0.2– 20]20% [0.1–35]25% [5–50]
Quality controls
  • a α and ß are parameters of the characteristic function.

  • b Center and spread denote mean and standard deviation for normal distribution.

  • c α expresses constant imprecision at low concentration.

  • d ß expresses relative imprecision similar to the coefficient of variation. For lognormal distribution, respective values are also provided on a non-logarithmized scale for better comparability.