Measurement Uncertainty Estimation (ISO 15189)

Comprehensive measurement uncertainty evaluation following ISO 15189, ISO/IEC Guide 98-3 (GUM), and JCGM 100:2008 guidelines. Calculates Type A and Type B uncertainties, combined and expanded uncertainty, and uncertainty budgets for clinical laboratory measurements. Essential for laboratory accreditation and quality assurance.

Usage

measurementuncertainty(
  data,
  measurement,
  reference_value,
  replicate_group,
  calibrator,
  operator,
  instrument,
  uncertainty_method = "gum_approach",
  confidence_level = 0.95,
  coverage_factor = 2,
  type_a_components = "repeatability,intermediate_precision,operator_variability",
  type_b_components =
    "calibration_uncertainty,reference_material_uncertainty,temperature_effects",
  calibration_uncertainty = 1,
  reference_material_uncertainty = 0.5,
  temperature_uncertainty = 0.1,
  pipetting_uncertainty = 0.2,
  sample_stability_uncertainty = 0.3,
  matrix_effects_uncertainty = 0.2,
  monte_carlo_simulations = 1e+05,
  distribution_types = "normal,uniform,triangular",
  correlation_analysis = TRUE,
  sensitivity_analysis = TRUE,
  budget_optimization = TRUE,
  measurement_model = TRUE,
  validation_experiments = FALSE,
  proficiency_testing_data = FALSE,
  interlaboratory_comparison = FALSE,
  clinical_significance = TRUE,
  iso15189_compliance = TRUE,
  uncertainty_plots = TRUE,
  budget_plots = TRUE,
  monte_carlo_plots = TRUE
)

Arguments

data: the data as a data frame
measurement: Laboratory measurement values for uncertainty analysis
reference_value: Reference or certified values for bias estimation
replicate_group: Identifier for measurement replicates or runs
calibrator: Calibrator or standard identifier
operator: Operator identifier for operator variability
instrument: Instrument identifier for instrument variability
uncertainty_method: Method for measurement uncertainty evaluation
confidence_level: Confidence level for expanded uncertainty
coverage_factor: Coverage factor for expanded uncertainty calculation
type_a_components: Comma-separated list of Type A uncertainty components
type_b_components: Comma-separated list of Type B uncertainty components
calibration_uncertainty: Relative uncertainty from calibration
reference_material_uncertainty: Uncertainty of reference materials
temperature_uncertainty: Uncertainty due to temperature variations
pipetting_uncertainty: Uncertainty from pipetting operations
sample_stability_uncertainty: Uncertainty due to sample stability
matrix_effects_uncertainty: Uncertainty from matrix effects
monte_carlo_simulations: Number of Monte Carlo simulations
distribution_types: Distribution types for uncertainty components
correlation_analysis: Analyze correlations between uncertainty components
sensitivity_analysis: Perform sensitivity analysis of uncertainty components
budget_optimization: Optimize uncertainty budget for cost-effectiveness
measurement_model: Define and validate measurement model
validation_experiments: Design experiments to validate uncertainty estimates
proficiency_testing_data: Incorporate proficiency testing results
interlaboratory_comparison: Compare uncertainty with other laboratories
clinical_significance: Evaluate clinical significance of uncertainty
iso15189_compliance: Verify compliance with ISO 15189 requirements
uncertainty_plots: Generate uncertainty analysis plots
budget_plots: Create uncertainty budget visualizations
monte_carlo_plots: Generate Monte Carlo simulation plots

Value

A results object containing:

Usage

Arguments

Value

Examples