Setting Up the Experiment
Lab Settings Configuration
Before creating a reference interval 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 — After creating a lab area, add at least one analyzer to that location 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 reference interval experiment, you will configure the following required fields:
- Days — The number of days over which measurements were collected. CLSI EP28 recommends a single-day design; multi-day collection is supported when logistically necessary.
- Replicates per individual — The number of measurements per reference individual per day. Most verification studies use a single measurement per individual (1 replicate). Multiple replicates are optional and can be used to assess within-individual variability.
- Total samples — The total number of reference individuals enrolled. CLSI EP28 requires a minimum of 20. If the reference interval is partitioned by demographic subgroup, 20 individuals are required per partition.
- Confidence level — The statistical confidence level used for interval calculations and reporting (typically 95%).
- Reference interval lower bound — The lower limit of the preestablished reference interval being verified, exactly as published by the manufacturer or source study.
- Reference interval upper bound — The upper limit of the preestablished reference interval being verified.
The following fields are optional but recommended for traceability:
- Operator — The person performing the measurements. Retained in the report for documentation purposes.
- Reagent lot — The lot number of the reagent used during the study.
- Calibrator — The calibrator material or lot used during the study.
Entering Data
Each row of data represents a single measurement. The following columns are required:
| Column | Description |
|---|---|
| Sample ID | Unique identifier for each reference individual. Rows sharing the same Sample ID belong to the same individual and are treated as replicates from that person. |
| Day | The day the measurement was performed. Used to assess between-day variability when the study spans multiple days. |
| Replicate | The replicate number for measurements from the same individual on the same day. Enter 1 for single-measurement studies. |
| Raw Value | The measured result exactly as reported by the instrument. Preserve all decimal precision — do not round. |