The tables list each study type's columns: the use a column is given under Adjust columns in Import a file, the matching column in the Data grid, whether the study needs it, and what to enter. See also Importing a file, Numbers, units and identifiers and Templates and downloads.
Fields every study type offers#
These columns are optional.
| Column use | What to enter |
|---|---|
| Excluded | yes/no, true/false or 1/0, any case. Leave empty to include the row. An excluded row needs a reason |
| Exclusion reason | Free text, up to 500 characters |
| Unit | Must match the study's unit exactly. Rows in other units form separate groups |
| Analyte | Compared with the study's analyte |
| Sample type | For example Serum. Compared with the study's matrix |
| Instrument | Compared with the study's instrument |
Unit, Analyte, Matrix and Instrument sort rows into groups. This study gets the rows that match it, and other groups can become new studies. See Files that mix analytes, matrices, instruments or units. Qualitative agreement has no unit, so delete any Unit column before importing. In instrument comparison, Instrument is required.
When the file has no level, day or run column, each is set to 1. Other missing columns, the level in linearity, and the day and run in a bias check stay blank.
Headings the app recognizes#
A matching heading is read as that column use. Case and a trailing unit in brackets are ignored, so Result (mg/dL) counts as result. A heading that contains a recognized word, in English, German or French (for example Ergebnis or Probe), is read the same way. Numbered columns such as Rep1 and Rep2 are offered as one result column with a row per value. A heading that can mean several things (x, y, test, reference, id, sample, value, concentration, time, factor, group, sex, system or reason) is offered as a suggestion for you to confirm. If two columns match one use, you choose.
| Field | Recognized headings |
|---|---|
| ID | specimen, specimen id, specimen_id, material id, material_id, id, sample, sample id, subject, subject id, pool, pool id, specimen / material id |
| Result | result, value, measurement, measured, measured result, measured value, result category |
| Comparative method result | comparator, comparator result, comparator_result, reference, reference result, x, comparative, comparative result, comparative method result |
| Test method result | candidate, candidate result, candidate_result, test, test result, y, test method result |
| Level | level, group, partition, sex, analyte level, material level, concentration level |
| Day, Run, Replicate | day; run; replicate |
| Unit, Analyte, Matrix | unit; analyte; matrix |
| Instrument | instrument, device, analyzer, system |
| Excluded | excluded |
| Exclusion reason | exclusion reason, exclusion_reason, reason |
| Expected or assigned concentration | expected, expected concentration, expected result, nominal concentration, assigned concentration, concentration |
| Lot | lot, reagent lot, reagent_lot, calibrator lot, calibrator_lot |
| Specimen volume | specimen volume, volume specimen, volume_specimen, sample volume |
| Diluent volume | diluent volume, volume diluent, volume_diluent |
| Stated dilution factor | dilution factor, dilution_factor, factor, dilution, stated factor |
| Serial steps | serial steps, serial_steps, steps |
| Diluent | diluent |
| Sequence position | position, sequence position, order, sequence |
| Role | role, sample role, aliquot role, material role |
| Interferent concentration | interferent concentration, interferent conc, interferent_conc, interferent |
| Elapsed time | timepoint, time point, time, elapsed time, storage time |
| Storage condition | condition, storage condition, handling condition, storage |
Descriptive summary, repeatability and bias against an assigned value#
Chapters: Descriptive summary, Repeatability, Bias against an assigned value.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Specimen / material ID | Except result-only descriptive imports | Coded ID of the specimen or control material; descriptive imports generate IDs when this column is absent |
| Result | Result | Yes | The measured value, in the study unit |
| Level or group | Level | No | Concentration or control level. Each level is summarized separately |
| Day | Day | No | Day label |
| Run | Run | No | Run label |
| Replicate | Replicate | No | Replicate label |
Repeatability expects one material, day and run for each level. For bias, enter each level's assigned value on Set up, and record Day and Run: repeats of one material get a mean and bias interval only when they share one recorded day and run.
Multi-day precision#
Chapter: Multi-day precision.
Same fields as above. Day, Run and Replicate are also required, though the dialog doesn't mark them. Use one material for each level and at least two days. Every day needs the same number of runs, and every run the same number of replicates, at least two.
Reference interval verification and establishment#
Chapters: Reference interval verification, Reference interval establishment.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Subject ID | Yes | Coded ID of the reference subject. A subject with repeat draws is flagged and counted once |
| Result | Result | Yes | The measured value |
| Level or group | Partition | No | The partition, for example female or male. Each partition is analyzed separately. Without it, all rows form partition 1 |
| Replicate | Replicate | No | Replicate label |
Day and Run can be imported but aren't shown in the grid.
Linearity#
Chapter: Linearity.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Expected (assigned) value | Expected concentration | Yes | The prepared concentration, zero or more |
| Result | Result | Yes | The measured value |
| Level or group | Level | No | Level label |
| Specimen or material ID | Specimen ID | No | ID of the preparation |
| Day, Run | not shown | No | Labels |
| Replicate | Replicate | No | Replicate label |
Dilution verification#
Chapter: Dilution verification.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Specimen ID | Yes | Coded ID of the high specimen |
| Result | Measured result | Yes | The measured post-dilution result |
| Specimen volume | Specimen volume | See rule | Specimen volume, in the same unit as the diluent volume |
| Diluent volume | Diluent volume | See rule | Volume of diluent |
| Dilution factor | Stated factor | See rule | Overall dilution factor, for example 5. Use 1 for undiluted material |
| Serial dilution steps | Serial steps | See rule | Stepwise factors, for example 5, 2, or 5; 2 in a decimal-comma study. The overall factor is their product |
| Diluent | Diluent | No | Name of the diluent |
| Level or group | Level | No | Level label |
| Replicate | Replicate | No | Replicate label |
Each row needs both volumes, a stated factor or serial steps. If you give more than one, they must agree. Give a factor as a number, for example 5 for a 1-in-5 dilution.
Method comparison#
Chapter: Method comparison.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Specimen ID | Yes | Coded specimen ID |
| Comparative method result | Comparative method (x) | Yes | Result by the comparative method |
| Test method result | Test method (y) | Yes | Result by the test method, on the same specimen |
| Level or group | Specimen group (level) | No | A subgroup label |
| Replicate | Replicate | No | Replicate label. Replicate pairs of one specimen are averaged |
Put both results for a specimen in the same row.
Instrument comparison#
Chapter: Instrument comparison.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Specimen ID | Yes | Coded specimen ID, repeated on each instrument's row |
| Instrument | Instrument | Yes | The instrument that produced this result |
| Result | Result | Yes | The measured value |
| Level or group | Level | No | Level label |
| Replicate | Replicate | No | Replicate label |
Enter one row for each result. The instrument list on Set up is filled from the file. Unit, Analyte and Matrix still group the file.
Reagent lot comparison#
Chapter: Lot comparison.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Specimen ID | Yes | Coded specimen ID. An ID beginning with QC (any case) marks quality-control material |
| Result | Result | Yes | The measured value |
| Lot | Lot | Yes | Must match the Previous lot or New lot on Set up exactly |
| Level or group | Level | No | Level label |
| Day, Run, Replicate | Day, Run, Replicate | No | Labels |
Qualitative agreement#
Chapter: Qualitative agreement.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Specimen ID | Yes | Coded specimen ID |
| Comparative method result | Comparative method result | Yes | A declared category or nonreportable label |
| Test method result | Test method result | Yes | A declared category or nonreportable label |
| Replicate | Replicate | No | Replicate label. The first included row for a specimen is its result |
Set the allowed values on Set up. By default the result categories are negative and positive, and the nonreportable labels are equivocal, invalid and indeterminate. Case is ignored. See Qualitative results that are not reportable.
Near-cutoff precision#
Chapter: Near-cutoff precision.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Sample ID | Yes | Coded sample ID |
| Expected (assigned) value | Concentration | Yes | The sample concentration, above zero |
| Result | Result category | Yes | A declared category or nonreportable label |
| Day | Day | No | Day label |
| Replicate | Replicate | No | Replicate label |
Detection limits#
Chapter: Detection limits.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Material ID | Yes | Coded ID of the blank or low-level material. Give each material one role and one assigned concentration |
| Sample role | Role | Yes | blank (analyte-free material) or low (low-level material), any case |
| Result | Result | Yes | The measured value. Blanks often give negative values. Enter <x only with the rank-below setting |
| Expected (assigned) value | Assigned concentration | For LoQ low materials | Required and above zero for low materials in a LoQ study |
| Lot | Reagent lot | No | Lot label |
| Day, Run, Replicate | Day, Run, Replicate | No | Labels |
Carryover#
Chapter: Carryover.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Run | Run | Yes | Run or sequence ID. Each run gets its own decision |
| Position in the run | Sequence position | Yes | A whole number, such as 3, used once in each run. It sets the order |
| Sample role | Role | Yes | high, low, H or L, any case |
| Result | Result | Yes | The measured value |
| Specimen or material ID | Material ID | No | ID of the low or high material |
In the 21-position design, each run has positions 1 to 21 in the order L L L H H L H H L L L L H H L H H L H H L, from one low and one high material.
Interference#
Chapter: Interference.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Pool ID | Yes | Shared by the base, control and test aliquots of one preparation |
| Sample role | Role | Yes | base (neat specimen), control (vehicle-matched, no interferent) or test (with interferent), any case |
| Interferent concentration | Interferent concentration | Yes | For test aliquots, the interferent concentration, above 0, in the unit set on Set up. For base and control aliquots, leave it empty or enter 0 |
| Result | Result | Yes | The measured analyte value |
| Level or group | Analyte level | No | Label such as low or high. Each level is analyzed separately |
| Replicate | Replicate | No | Replicate label |
Stability#
Chapter: Stability.
| Column use | Grid column | Required | What to enter |
|---|---|---|---|
| Specimen or material ID | Material / specimen ID | Yes | Coded ID |
| Time point | Elapsed time | Yes | A number in the Time unit set on Set up, for example 24 for 24 h. Baseline rows use the Baseline time, 0 by default |
| Result | Result | Yes | The measured value |
| Storage condition | Storage condition | For non-baseline rows | A condition set on Set up, any case. Baseline rows can leave it blank |
| Replicate | Replicate | No | Replicate label |
Sigma metric#
Chapter: Sigma metric.
Enter the concentration, allowable total error, bias and imprecision in the Data stage, or copy them from other studies' results.