Set up: study details and settings

Set up holds the collection plan, study details, acceptance limits and calculation settings. Each study's own settings, such as assigned values or decision levels, are under Settings on its reference page.

Blank template (CSV) and Run this study sit at the top of the stage. The first downloads the study's empty column template; the second opens the study's guide in this manual.

Collection plan

Open Collection plan to see what to prepare, decide, collect and check. Its heading gives the entered row count, or the suggested total before rows exist; it starts closed and remembers your choice for the browser session.

The Suggested plan is an example starting design. Entered data counts the study's current rows; repeatability and method comparison show any shortfall against their suggested counts, and a saved Study plan states its required pairs. The Calculation minimum is only what the software needs to calculate. Needed in this study before calculating names missing settings. A sigma study shows Values to gather.

Study details

Field	What to enter
Study title	For example `Glucose · repeatability · analyzer B`. Up to 140 characters.
Study type	Fixed once data exist; see choosing a study.
Analyte	Spell it the same in every study. The project groups studies by it (analytes).
Unit	One unit for the whole study. Units are never converted. After a unit change, enter the medical decision levels, the claimed reportable limits and each marked limit again in the new unit; Save asks you to confirm when results exist. Correcting how the same unit is written, such as `mg/dl` to `mg/dL` or `umol/L` to `µmol/L`, keeps those values, and the limits and lot plan take the new spelling. Qualitative agreement has no unit.

Analyte is required before calculating. Unit is also required except for qualitative agreement. Open Report details (optional) for Instrument, Method, Reagent lot, Calibrator lot, Specimen / material matrix and Study date. These identify the work in the report.

The fields vary by study. Method comparison names Comparative method (x) and Test method (y); lot comparison names Previous lot and New lot; instrument comparison lists its analyzers in its own panel. Only a study's own design fields, such as its two lots, affect the calculation.

Calculation settings

Open Calculation settings to change the choices shown in its heading, for example 95% confidence · automatic decimal places · decimal point.

Setting	What it does
Confidence level	90%, 95% or 99% for the study's estimate intervals. It is different from a reference interval's population coverage. Manufacturer-claim verification has its own confidence setting; the calibration-verification precision index uses a 90% interval. Sigma and the 21-position carryover design have no intervals.
Measurement scale	Ratio scale when zero means none of the analyte, as for most concentrations. Interval scale when zero is arbitrary, as for pH or °C. On an interval scale, CV, percent bias and recovery are not calculated, and percentage limits can't be decided.
Numeric convention	Decimal point or decimal comma in your results. Changing it after results exist asks you to confirm. The original text is kept. See numbers, units and identifiers.
Display decimal places	Automatic (the default) shows calculated concentrations to one decimal place beyond your results: whole-number results give one place. Or choose 0 to 8. SDs and fitted parameters retain at least three significant digits at small magnitudes. CVs and percentages show at most 2 places, slopes at least 3. Entered values and limits print as entered. Acceptance decisions use full-precision values.
Permit negative results	Tick it for methods that can report negatives, such as blanks. Otherwise a row with a negative result is flagged and the calculation stops until you correct or exclude it.

A method comparison sets its Primary regression in the Method comparison panel. Choosing Deming reveals How λ is supported; for another primary fit, open Deming settings for the other fits if needed. Each study shows only the settings that apply to it.

The New study dialog

Every study asks for Analyte and Unit and an optional Study title. Qualitative agreement needs only Analyte. A blank title becomes, for example, Glucose · repeatability. Some studies ask more:

Study	Extra questions
Method comparison	Comparative method or instrument, Test method or instrument
Instrument comparison	Reference analyzer
Bias check	Assigned value
Dilution verification	Lowest reportable value before dilution, Highest reportable value before dilution, Expected value of the undiluted sample
Reagent lot comparison	Previous lot name, New lot name. Set the required matched pairs, each specimen's allowable error and the concentration groups on Set up.
Verify a reference interval	Reference limits (two-sided or one-sided), Claimed lower reference limit, Claimed upper reference limit
Establish a reference interval	Reference limits (two-sided or one-sided)
Detection limits	Which limit (limit of blank, detection or quantitation)
Interference	Interferent, Interferent concentration unit
Stability	Time unit, What is stored, Largest acceptable change from baseline (%) (optional)

The study's Blank template (CSV) on Set up and Data has the columns it needs; your own columns can have any names and order.

Imported files

On Set up, open Imported files and choose a file name to download it. See downloading the original import.

Save changes shares your edits; see Save, discard or combine changes.