Setting Up the Experiment

Before creating an interference experiment, complete the following one-time setup steps in Lab Settings:

• Add a lab area — A lab area must be created first. All analyzers and assays are organized under a location.
• Add an analyzer — Add at least one analyzer to the lab area representing the instrument being evaluated.
• Add an analyte / assay — Click the analyzer row to open its detail page, then click Add assay. Select from the internal database or click Manual entry if the assay is not listed.

Select the experiment type (Paired Difference, Dose Response, or Both), then configure the fields for each selected experiment.

Dose Response Configuration

• Interferent name and units — The name of the interferent being tested (e.g., "Bilirubin") and its concentration units (e.g., "mg/dL"). Used for axis labels in the scatter plot and report.
• Measurand level — The analyte concentration at which the dose-response experiment is performed. Typically a mid-range clinically relevant concentration.
• Allowable difference (absolute or %) — The maximum acceptable bias attributable to the interferent. Can be entered as an absolute value in analyte units or as a percentage of the measurand concentration. If entered as a percentage, it is automatically converted to analyte units using M0 for comparison and display.
• Maximum interferent concentration — The highest interferent concentration to be tested. CLSI EP07 recommends testing at 2–3× the therapeutic or maximum expected concentration in patient specimens. Intermediate levels (25%, 50%, 75%) are then derived from this maximum.
• Number of replicates — The number of replicate measurements per concentration level. Use the replicate calculator to determine the minimum required based on the method's repeatability SD and the allowable difference. CLSI EP07 minimum is 5 replicates per condition.

Paired Difference Configuration

• Number of levels (1 or 2) — Select 1 level for a single measurand concentration or 2 levels (e.g., low and high) for a more comprehensive screening evaluation. A separate paired-difference analysis is performed for each level.
• Measurand concentration (per level) — The analyte concentration for each level. Typically chosen to correspond to medically relevant decision points (e.g., a low normal and a high abnormal value).
• Allowable difference per level (absolute or %) — The acceptance threshold for each measurand level. Different allowable differences can be set for each level if the clinical tolerance varies across the analytical range.
• Maximum interferent concentration — The interferent concentration used for the test samples. The control group is measured without interferent (0 concentration); the test group contains the interferent at this maximum concentration.
• Number of replicates — Minimum 5 per condition per level per CLSI EP07. Use the replicate calculator for precision-adjusted estimates.

The following fields are optional but recommended for traceability:

• Operator — The person performing the measurements.
• Reagent lot — The reagent lot number used during the study.
• Calibrator — The calibrator material or lot used during the study.

Data can be uploaded via the AI-assisted file import or entered manually. The expected format is long (one row per replicate):