Studies, statistics and features.

Compare the statistics and plots available for each study, then review analyzer imports, acceptance limits, reports, team workspaces and hosting.

Studies

Precision

StudyStatisticsPlots
Repeatability
  • Mean with confidence interval
  • Repeatability SD and CV
  • Median, variance and quartiles
  • Minimum and maximum
  • Manufacturer's precision claim check
  • Results in run order
  • Histogram
  • Normal Q–Q plot
  • Box plot
Multi-day precision
  • Repeatability SD and CV
  • Between-run SD
  • Between-day SD
  • Within-laboratory SD and CV
  • Grand mean with confidence interval
  • Nested ANOVA for balanced and unbalanced designs
  • Manufacturer's precision claim check
  • Results by day and run

Comparison and bias

StudyStatisticsPlots
Method comparison
  • Passing–Bablok regression
  • Deming regression
  • Weighted Deming regression
  • Ordinary least squares
  • Slope and intercept with confidence intervals
  • Pearson r
  • Mean bias with 95% limits of agreement
  • Bias at medical decision levels
  • Each specimen against its allowable difference
  • Deming λ from replicates, linked precision studies or a stated value
  • Reportable-range coverage
  • Regression plot with confidence band
  • Bland–Altman difference plot, absolute or relative
  • Residual plot
Instrument comparison
  • Up to 30 instruments, one of them the reference analyzer
  • Mean difference with confidence interval
  • 95% limits of agreement
  • Bias at each concentration level
  • Each specimen against its allowable difference
  • Differences against the reference result
  • Differences by analyzer
Bias check
  • Bias with confidence interval
  • Relative bias
  • Recovery
  • Mean, SD and CV at each level
  • Assigned-value standard uncertainty
  • Combined standard uncertainty
  • Bias interval with the assigned value's uncertainty
  • Results in run order against the assigned value
Reagent lot comparison
  • New-lot minus previous-lot difference for each specimen
  • Each specimen against its allowable difference
  • Mean difference with confidence interval
  • Lot plan coverage by concentration group
  • QC material mean on each lot
  • SD of the differences and within-specimen SD
  • New lot against previous lot
  • Lot difference plot
PT and INR
  • Geometric mean normal PT with confidence interval
  • Proposed PT and INR interval checks
  • INR programming check
  • PT/INR reagent lot comparison with separate PT and INR allowances
  • PT/INR lot comparison
Glucose meter error grids
  • Clarke error grid zones A–E
  • Parkes error grid zones A–E, type 1 and type 2
  • Zone counts and percentages for each meter
  • Signed percentage differences
  • 95th percentile absolute difference
  • Error grid with each pair in its zone

Measuring range

StudyStatisticsPlots
Linearity
  • Straight-line fit through the level means
  • Deviation from the fitted line
  • Bias and recovery against assigned concentrations
  • Every replicate against its assigned value
  • Reportable range verification
  • Theoretical values from equal dilution steps
  • Level means against assigned concentration
  • Deviation from the line
  • Percent recovery
Calibration verification
  • Mean and replicate error against assigned values or target ranges
  • Range coverage at each endpoint
  • Within-run SD and mean confidence interval
  • Optional linearity check
  • Optional precision index
  • Difference from the assigned value at each level
Dilution verification
  • Corrected result for each dilution factor
  • Recovery against the expected neat concentration
  • Each reading against the reportable range
  • Verified range for each pool
  • Volume, serial and stated dilutions
  • Recovery by dilution
  • Readings against the reportable range
Detection limits
  • Limit of blank, rank-position or parametric, with confidence interval
  • Limit of detection with the small-sample multiplier
  • Pooled low-level SD
  • Limit of quantitation against a CV or total-error goal
  • Claimed LoB, LoD and LoQ verification
  • Results reported below a limit
  • Results by material against each limit
  • Precision profile

Reference intervals

StudyStatisticsPlots
Reference interval verification
  • Subjects below, within and above a claimed interval
  • Two-sided interval or one-sided limit
  • Single or staged verification rules
  • Results for each partition
  • 1.5·IQR outlier review
  • Counts with excluded subjects added back
  • Subject values against the claimed limits
  • Histogram
  • Normal Q–Q plot
  • Box plot
Reference interval establishment
  • Nonparametric, parametric and log-normal reference limits
  • Automatic estimator choice with Shapiro–Wilk
  • Confidence interval on each limit
  • Two-sided interval or one-sided limit for each partition
  • 1.5·IQR outlier review
  • Limits with excluded subjects added back
  • Histogram with limits and their confidence intervals
  • Raw points
  • Normal Q–Q plot
  • Box plot

Qualitative tests

StudyStatisticsPlots
Qualitative agreement
  • Contingency table
  • Overall, positive and negative percent agreement with Wilson intervals
  • Cohen's kappa and weighted kappa
  • McNemar exact test
  • Positive-proportion difference
  • PPV and NPV, observed or modeled from prevalence
  • Resolved results from retest or adjudication
Near-cutoff precision
  • Hit rate with Wilson interval at each concentration
  • Probit fit
  • C5, C50 and C95 with Fieller limits
  • Pearson chi-square fit diagnostic
  • Hit rates with the fitted probit curve

Sample and material effects

StudyStatisticsPlots
Interference
  • Effect at each interferent concentration, test minus control
  • Relative effect (%)
  • Welch confidence interval on each effect
  • Vehicle effect
  • Effect by interferent concentration
Carryover
  • 21-position high and low sequence
  • Lows after highs minus lows after lows
  • Error limit of 3 SD or your own limit
  • A decision for each run
  • Each run in sequence order
Stability
  • Change from baseline at each time and storage condition
  • Paired or independent designs
  • Longest tested time within the allowable change
  • Claimed duration check
  • Specimen, reagent, calibrator and control material stability
  • Change from baseline over time

Summaries and QC

StudyStatisticsPlots
Measurement uncertainty
  • Top-down uncertainty from within-laboratory precision and bias
  • Precision, bias and assigned-value components
  • Combined standard uncertainty
  • Expanded uncertainty at your coverage factor
  • Uncertainty of the mean bias
Sigma metric
  • Sigma at each stated concentration
  • Bias and precision copied from saved studies
  • Grades from Excellent to Unacceptable
  • Suggested QC rules and control measurements
  • Method decision chart
Proficiency tracking
  • Bias and percentage bias against the peer or all-method group
  • SDI
  • Local acceptance beside the provider's grade
  • Bias history
Descriptive summary
  • Mean with confidence interval
  • Median, SD, CV, variance and quartiles
  • Lowest and highest results
  • Geometric statistics for positive results
  • Results in entry order
  • Histogram
  • Normal Q–Q plot
  • Box plot
QC targets (QC export)
  • Candidate target mean, SD and CV for each instrument, lot, analyte and level
  • Estimated SD ranges
  • Excluded, missing and duplicate rows set aside for review
  • Levey–Jennings plot with ±1, 2 and 3 SD lines

Features

Study design and limits

Run this study guides
A bench guide for every study: what to prepare, how many specimens, runs and replicates to collect, and how to enter them.
Suggested collection plans
Each study opens with an example design for its levels, specimens, days and runs.
Your acceptance limits
Limits in the study unit, as a percentage or both, and concentration-dependent limits across ranges.
CLIA and CAP limits
A built-in CLIA and CAP proficiency-testing table, searched by analyte name or abbreviation.
Limits on any statistic
Set a limit on any calculated statistic, including slope, intercept and between-day SD.
Reusable limits
Save a study's limits as a named set and copy them into later studies of the same analyte and unit.
Allowable error from published sources
Clinical requirement, CLIA proficiency-testing criterion, biological variation at minimum, desirable or optimum performance, or achievable peer precision, saved with its source and formula.

Data entry and imports

Analyzer and LIS imports
Import CSV, TSV and Excel exports, or paste a spreadsheet table, and select the study columns.
Saved import formats
Save an analyzer export's column mapping and reuse it for later files.
Split imports
Choose which groups to import from a file with several analytes, matrices, instruments or units.
Panel comparisons
Import a whole analyte panel from two methods, review the specimen matches and calculate every test's method comparison together.
Data grid
Type or paste results into a grid shaped for the study's design, with each problem marked in its cell.
Study codes for accession numbers
Accession or order numbers in a specimen column can be replaced with study codes on import, with a code key you download once.
Censored and missing results
Results such as <0.5, blanks and instrument flags stay as written and are marked for correction or exclusion.
Corrections and exclusions
Correct a value with the original kept on record, or exclude a result with its reason.
Templates and example files
A blank CSV template with each study's columns, and an example file for every study that takes an import.

Results and review

Met, Not met and Undecided
Each limit beside its observed value and outcome, with the reason for any Undecided result.
Methods and sources
Every calculation names its method and the published sources behind it.
Linked studies
Precision studies supply a method comparison's Deming λ, and saved bias and precision studies supply sigma and measurement uncertainty, with a warning when a source study changes.
Plot downloads
Plots as SVG or PNG, each with a study title, the result count and labelled axes.

Reports and records

Study reports
Page 1 is the decision page with each limit, its result and the sign-off; the measurements follow from page 2.
PDF and print
Download each report as a PDF or print it, also in black and white or on another paper size.
Sign-off
Sign a report under your own account, with your email and name recorded.
Amendments
A signed report stays locked, and an amendment is saved as a new version beside it.
History and revisions
Open any saved revision, calculation or signed report exactly as it was saved.
Project reports
All of a project's studies in one document, grouped by analyte, each with its own outcome.
Evidence binders
Signed reports bound into one PDF by analyte or analyzer, with a contents page and a CAP evidence index.
Evidence archive
The data, calculations and imports behind every report in a binder, in one download.
Study downloads
Study data and results summaries as CSV, each calculation as JSON, the report files and the original imports.
Workspace records
Every record in the workspace, with its history and SHA-256 checksums, as one ZIP.

Workspace and team

Shared workspaces
Invite colleagues into your laboratory's workspace; each person can belong to several.
Roles
Owners and Administrators manage members, Editors set up and run studies, and Viewers read, download and sign reports.
Working together
Each person edits a private draft. LabRuns combines separate changes on save and asks you to resolve changes to the same value.
Projects
Gather a go-live or an annual review into a project, and find studies by analyte, analyzer or lot.
Library
Save instruments, analyte profiles, allowable errors, materials and reagent lots, and create every study a new lot needs from its profile.
Recurring work
Schedules for periodic studies, new lots and shipments, with overdue and upcoming work on one list.
Workspace activity
Owners and Administrators can review membership changes, administrative actions, exports and Trash.
Trash
Projects and studies moved to Trash can be restored for 30 days.
Laboratory plan
One plan for the institution covers every member and their workspaces, after a free first week.

Hosting and security

United States hosting
The application, database, imports, reports and backups stay in the United States.
Encryption
HTTPS to your browser, an encrypted private network, and encryption at rest for the database and backups.
Email sign-in codes
Single-use sign-in codes, seven-day sessions and sign-out of every device at once.
Workspace isolation
The database returns records only from the workspace a request belongs to.
Locked records
Saved revisions, calculations and signed reports stay as saved, and SHA-256 checks catch any change.
Backups
A continuous database archive and daily backups, with the latest 14 copies each restored and checked.
Monitoring
An independent monitor checks the service, PDF printing and backups every five minutes.

Calculation evidence

Published methods
The formulas and scientific sources behind every study type.
Calculation checks
Every study type's values and decisions are checked against independent recalculations and published examples before each release.
Evaluation package
Study inputs, expected results and reports for every study type, to run the same studies yourself.
Institutional review
One facts table for your laboratory's software review, covering data handling, access and support.
CAP checklist guides
What each CAP checklist item asks a laboratory to keep, marked on an example report.

Run your next verification study in LabRuns.

Open the live example without an account, or start your free week and bring in your own analyzer's results.