Setting Up the Experiment
Lab Settings Configuration
Before creating a carryover 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.
Creating the Experiment
When creating the carryover experiment, you will configure the following required fields:
- Low specimen concentration — The target concentration of the low-concentration pool. Used when the error limit is defined as a percentage of the low concentration.
- High specimen concentration — The target concentration of the high-concentration pool. Should be representative of the highest concentrations encountered in routine patient testing.
- Allowable error — The maximum acceptable carryover. Choose from three options:
Auto
Automatically set to 3 × the Low (Control) SD. This derives the error limit from the observed baseline variability, providing a statistically grounded threshold without requiring an external acceptance criterion. Appropriate when no published or regulatory allowable error exists for the analyte.
Concentration (absolute value)
A user-specified absolute error limit in the same units as the result. Use this when a specific maximum acceptable contamination is known (e.g., from a manufacturer's specification or internal quality policy).
Percent
A percentage of the low specimen concentration. For example, 10% of a low concentration of 5.0 mg/dL sets the error limit at 0.5 mg/dL. Useful when the acceptable contamination is defined relative to the low pool's expected value.
The following fields are optional but recommended for traceability:
- Operator — The person performing the measurements, retained in the report for documentation.
- Reagent lot — The lot number of the reagent used during the study.
- Calibrator — The calibrator material or lot used during the study.
Entering Data
Data is entered as 21 raw values in the fixed testing sequence. The sequence positions and relative concentrations are pre-populated — you only need to enter the measured result for each position:
| Column | Description |
|---|---|
| Sequence | The measurement order (1–21). Pre-populated and fixed — do not alter the sequence. |
| Relative Concentration | "Low" or "High" — pre-populated based on the study protocol. Indicates which specimen pool was measured at that position. |
| Raw Value | The actual measured result from the instrument at that sequence position. Enter values in order as they were measured. |