Setting Up the Experiment
Lab Settings Prerequisites
The MIMC module requires at least two instruments to be pre-configured in Lab Settings before a study can be created. Complete the following setup steps first:
- Add a lab area — A lab area must exist before instruments can be assigned. All analyzers are organized under a location.
- Add at least two analyzers — Each instrument that will participate in the MIMC study must be added to a lab area with its model and serial number recorded. The MIMC module will not be available until at least two instruments are configured.
- Configure the analyte on each instrument — The analyte being compared must be added to every instrument in the study, and TEa must be configured for that analyte. All instruments in a MIMC study should be capable of measuring the same analyte.
Creating the Experiment
When creating the MIMC experiment, you will configure the following required fields:
- Reportable range (lower and upper bounds) — The validated analytical measurement range (AMR) for the analyte on these instruments. Used to calculate the Coverage Ratio and to display AMR limit markers on figures.
- Days — The number of days over which measurements were collected. Multiple days are recommended to assess reproducibility across testing sessions.
- Replicates per day — The number of measurements per specimen per instrument per day.
- Total paired observations — The total number of specimen-instrument measurement pairs in the study. A minimum of 3 paired observations is required.
- Bias allocation % — The percentage of TEa attributed to systematic bias. This value reduces the effective TEa used in the Error Index calculation, allocating a portion of the allowable error budget to imprecision.
- Confidence level — The statistical confidence level used for reporting (typically 95%).
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.
Instrument Configuration
After entering the experiment parameters, you will configure the instruments in the study using the Instrument Configuration card. First, select the number of instruments to include (2–30). A configuration table is then displayed with the following columns:
| Column | Description |
|---|---|
| Instrument ID | A sequential identifier automatically assigned to each instrument row. |
| Instrument Name (From Data) | A label you provide to identify this instrument in the study — typically the instrument's local name or designation. This name becomes the column header in the Measurement Data Entry table, followed by the serial number from Lab Settings in parentheses. |
| Lab Area | Select the lab area to pull instruments from. This must be selected before the Lab Instrument field becomes available. Populated from pre-configured locations in Lab Settings. |
| Lab Instrument (From Lab Settings) | After selecting a lab area, choose the specific analyzer from that location. The dropdown shows the instrument model and serial number as configured in Lab Settings. The serial number is automatically appended to the instrument name in the data entry table. |
| Target | Check this box to designate the instrument as the target (reference standard). The target instrument's measurements establish the reference value for each specimen. All other instruments are compared against it. If no instrument is checked, the median of all instruments serves as the target for each specimen. |
Target designation changes the analysis. When a target instrument is designated, only that instrument's values establish the reference; the target instrument itself is not evaluated (its Error Index is shown as "–"). When no target is designated, the median of all instruments is used as the reference, and every instrument's results are evaluated against that consensus value — meaning all instruments receive Error Index values.
Entering Data
Once instruments are configured, measurement data is entered in the Measurement Data Entry section. Column headers are populated automatically using the Instrument Name (From Data) label followed by the serial number from Lab Settings in parentheses — for example, Instrument 1 (12345). Each row represents a single specimen:
| Column | Description |
|---|---|
| Sample ID | Unique identifier for each specimen. The same Sample ID on multiple rows indicates replicate measurements from the same specimen. |
| Day | The day the measurement was performed. Used to assess between-day reproducibility of inter-instrument agreement. |
| Replicate | The replicate number for measurements from the same specimen on the same day. Enter 1 for single-measurement designs. |
| [Instrument columns] | One column per configured instrument. Enter the raw measured value from each instrument for that specimen. All instruments must have measured the same specimen to enable direct comparison. |