Setting Up the Experiment
Lab Settings Configuration
Before creating an LoB 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 used for the study.
- 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.
Creating the Experiment
When creating the LoB experiment, you will configure the following required fields:
- Total number of blank samples — The number of unique blank sample IDs in the study. CLSI EP17-A2 requires a minimum of 5.
- Total number of low-level samples — The number of unique low-level sample IDs in the study. CLSI EP17-A2 requires a minimum of 5.
- Number of days — The number of test days. CLSI EP17-A2 requires a minimum of 3 days to capture between-day variability.
- Replicates per day — The number of replicate measurements per sample per day per reagent lot. CLSI EP17-A2 requires a minimum of 4.
- Number of reagent lots — CLSI EP17-A2 recommends a minimum of 2 reagent lots. The LoB is calculated separately per lot and the maximum is reported.
- Analysis method — Nonparametric (default, no distributional assumptions) or parametric (assumes normally distributed blank measurements). The nonparametric method is preferred unless the blank distribution is confirmed to be approximately normal.
The following fields are optional but recommended for traceability:
- Manufacturer's LoB claim — If a manufacturer has published an LoB value in the package insert, enter it here. The module will compare the calculated LoB against this claim to determine whether the manufacturer's value is verified in your laboratory.
- Operator — The person performing the measurements, retained in the report for documentation.
- Calibrator — The calibrator material or lot used during the study.
Entering Data
Data can be uploaded via the AI-assisted file import or entered manually through the Measurement Data Entry form. The expected columns are:
| Column | Description |
|---|---|
| Sample ID | Unique identifier for each individual sample. Rows sharing the same Sample ID are pooled together during analysis — this is essential for calculating pooled SD across replicates. Each unique sample should have multiple measurements across days and replicates. |
| Reagent Lot | The reagent lot number for this measurement. Measurements are grouped by lot for per-lot LoB calculation. |
| Day | The day the measurement was performed (e.g., 1, 2, 3). Used to assess between-day variability in the blank distribution. |
| Replicate | The replicate number for this measurement within the same day and reagent lot (e.g., 1, 2, 3, 4). |
| Type | Indicates whether the sample is a blank ("Blank") or a low-level concentration sample ("Low-level"). The AI import can recognize alternative labels such as "Control" → Blank or "Patient" → Low-level. |
| Raw Value | The actual measured concentration as reported by the instrument. Record the value exactly as displayed — do not force blank readings to zero. |
Manual entry: When using the Measurement Data Entry form, enter the Sample ID and Raw Value for each measurement. Day, replicate, reagent lot, and sample type are structured by the form layout. Manual entry is available for those who prefer to avoid the AI import entirely.