Setting Up the Experiment

Before creating a method comparison experiment in Legion Diagnostics, complete the following one-time setup steps in Lab Settings:

• Add a lab area — A lab area must exist before analyzers or assays can be configured. All study data is organized under a location.
• Add an analyzer — Register the test method instrument under the lab area. The reference method instrument may also be registered if it is tracked within Legion Diagnostics.
• Add an analyte / assay — Click the analyzer row to open its detail page, then click Add assay. Select from the internal database (TEa is automatically populated from reputable reference sources) or click Manual entry if the assay is not listed.
• Total Allowable Error (TEa) — TEa is required for Legion Diagnostics to automatically evaluate pass/fail. It is auto-populated when the internal database is used, or must be configured manually. TEa is the basis for the allowable bias threshold.

When creating the method comparison experiment, you will configure:

• Number of days — The number of study days over which paired measurements will be collected. Multiple days help assess consistency of agreement over time and across calibration events.
• Replicates per day — The number of times each sample is measured per day on each method. Additional replicates improve precision of the bias estimate.
• Reference method name (X) — The name of the established or comparator method. Results from this method serve as the X variable in all regression and difference analyses.
• Test method name (Y) — The name of the candidate or new method being evaluated. Results from this method serve as the Y variable.
• Confidence level — 95% or 99%. Determines the width of the confidence intervals used for bias estimation and pass/fail evaluation. 95% is standard for verification; 99% is more conservative.
• Total paired observations — The planned total number of paired sample measurements (across all days and replicates). CLSI EP09C recommends a minimum of 40, preferably 100 or more.
• Bias allocation % — The percentage of TEa allocated to systematic error. Combined with TEa, this defines the allowable bias threshold for pass/fail.
• Medical decision points — Optionally include up to 5 clinically relevant concentrations for targeted bias evaluation. When MDPs are enabled, the regression method to be used for MDP bias calculation must be selected (Deming, Passing-Bablok, or OLS).
• Optional metadata — Operator (the person performing the study), reagent lot, and calibrator can be recorded for traceability and are included in the generated report.