How It Works

Experiment Types

The module supports three experiment configurations. The choice depends on whether the goal is screening, characterization, or both:

Paired DifferenceScreeningCLSI EP07 Chapter 5

Tests whether a specific interferent at its maximum expected concentration causes a statistically and clinically significant bias. Each condition (control at 0 interferent; test at maximum interferent concentration) requires a minimum of 5 replicates per measurand level. Supports 1–2 measurand levels. This experiment answers the question: "Is there significant interference at the highest likely clinical concentration of this interferent?" If paired difference testing shows significant interference, a dose-response experiment is typically performed to characterize the relationship.

Dose ResponseCharacterizationCLSI EP07 Chapter 6

Characterizes the interference relationship across multiple interferent concentrations — typically 5 levels at 0%, 25%, 50%, 75%, and 100% of the maximum concentration — at one measurand level. A minimum of 5 replicates per concentration level is recommended. A regression model (linear or quadratic) is fitted to the data, and the maximum interferent concentration at which interference remains within the allowable limit is identified from the model. This experiment answers the question: "At what interferent concentration does the bias become clinically unacceptable?"

BothScreening + Characterization

Combines both experiment types in a single study. Useful when comprehensive interference data is needed from one session, or when a laboratory chooses to proceed directly to characterization without a preliminary screening step. When entering data for both experiments, the Experiment Type column distinguishes which rows belong to the paired difference study and which belong to the dose-response study — values must be entered for the corresponding experiment type.