Every statistical tool we make, in one licence
Method validation with 11 CLSI protocols, diagnostic accuracy with ROC curves, survival analysis with Kaplan–Meier and Cox regression, statistical process control with Shewhart, CUSUM, and EWMA charts, plus the full general statistics toolkit — ANOVA, regression, PCA, and more.
Most organisations don’t fit neatly into a single edition. The IVD company running CLSI method validation studies also needs SPC on the manufacturing line. The clinical lab verifying a new assay also runs survival analysis for research publications. The quality team monitoring control charts also needs ANOVA and regression to investigate out-of-control events.
The Ultimate edition unlocks every feature across all four editions — Method Validation, Medical, Quality Control & Improvement, and Standard — in a single licence at US$575/yr, less than any two specialist editions bought separately. Already own a specialist edition? Upgrade for the difference in price.
We use Analyse-it frequently for our verification and pre-verification work, in accordance with CLSI guidelines for in-vitro diagnostics. It’s saved time and effort compared to the hodge-podge of applications we used before, JMP, SAS, etc…
Brian Noland, Ph.D.
Principal Scientist, Product Development
Biosite / Inverness Medical Innovations
Validate and verify measurement system performance
The complete CLSI method validation toolkit — precision, linearity, detection capability, method comparison, reference intervals, and diagnostic performance — with 11 evaluation protocols built in:
Precision with nested variance components, precision profiles, and five variance function models (EP05-A3)
Linearity with polynomial and weighted regression, Hsieh-Liu nonlinearity testing, and measuring interval (EP06-A)
Detection capability — LoB, LoD, LoQ using parametric, non-parametric, probit regression, and variance function approaches (EP17-A2)
Verification of precision and trueness against manufacturer claims (EP15-A3), interference testing (EP10-A3-AMD)
Compare methods and evaluate the impact of changes
Five regression models for method comparison — including Passing-Bablok, Deming, and weighted Deming — plus Bland–Altman agreement and total analytical error:
Establish reference intervals for clinical interpretation
Full range of reference interval methods — match the method to your sample size and distribution, partition where subgroups need separate ranges, and transfer or verify intervals when moving to a new measurement procedure:
Five quantile methods — parametric, non-parametric (three computation approaches), robust bi-weight, bootstrap, and Harrell–Davis
Partition by sex, age, ethnicity, or any combination of factors
Full range of transformations — log, square root, cube root, Box–Cox, Manly exponential, two-stage exponential/modulus
Transfer and verify existing intervals using regression or binomial proportion test
Establish and compare the ability of a diagnostic test to discriminate between patients with and without a condition — and find the decision threshold that balances sensitivity, specificity, and clinical cost:
Empirical and binormal ROC curves with DeLong AUC and confidence intervals (EP24-A2)
AUC comparison (DeLong) for up to 10 paired or independent tests
Sensitivity, specificity, likelihood ratios, predictive values, diagnostic odds ratio
We use Analyse-it for the analysis of data necessary to file 510k. We chose Analyse-it because it works in Excel, includes CLSI protocols, and, unlike EP-Evaluator, lets us analyze data directly from equipment without typing.
Thomas D Harrigan, Ph.D.
Technical Product Manager
Alfa Wassermann Diagnostic Technologies
Everything, in one licence
The Ultimate edition includes every feature from the Method Validation, Medical, Quality Control & Improvement, and Standard editions. If your organisation needs capabilities from more than one specialist edition — or you don’t want to have to choose — Ultimate is the simpler and cheaper option. You’ve already been using every feature during the 15-day trial.
Validated, reliable, trusted for over 30 years
Validated calculations
Every statistic tested against NIST Standard Reference Datasets, published datasets and thousands of internal test-cases. No reliance on Excel'sbuilt-in functions. See how we develop and validate Analyse-it →
Data stays on your PC
No cloud processing, no uploads, no third-party access. Your data never leaves your computer — essential when working with sensitive, confidential, or patient-identifiable data.
Standard Excel workbooks
Analyses are ordinary Excel workbooks that you can share with colleagues, archive for audit, and open on any machine with Excel — no Analyse-it licence required.
No formulas to break
Results contain no formulas, so they can't be accidentally edited or corrupted. The results you reported will be exactly what you find when you reopen the workbook.
Support for 11 CLSI protocols
The latest Clinical and Laboratory Standards Institute (CLSI) method validation protocols are recognised by the College of American Pathologists (CAP), The Joint Commission, and the US Food and Drug Administration (FDA).
I used Analyse-It for many product development, product troubleshooting, and technology evaluation activities… your product was the easiest to use, was accurate, and produced publication ready reports.
Stanley F. Cernosek, Ph.D.
Clinical Chemistry Reagent Development
Beckman Coulter, Inc.
Analyse-it has been a tremendous help. I’ve published and presented at national cardiology meetings and couldn’t have accomplished most of my research without it. Using Analyse-it, I even found errors or omissions in the work of our statistician!
Regina S. Druz, MD, FACC, FASNC
Director, Nuclear Cardiology
North Shore University Hospital
Example analyses
Download example datasets, open them in the trial, and see exactly what the output looks like.
Method Validation
Method comparison EP09-A3 Example 1.
Passing-Bablok, Deming regression, Bland-Altman limits of agreement.
Precision EP05-A3 Example 1.
Variance components, precision profile, variance function.
Reference intervals EP28-A3C Example 1.
Non-parametric reference interval with outlier detection.
Diagnostic performance EP24-A2 Example 1.
ROC curve, AUC, sensitivity and specificity at thresholds.
Medical
Survival analysis Kaplan–Meier, two treatment groups.
Survival curves with confidence bands. Log-rank test. Median survival with CIs.
Quality Control & Improvement
Control charts Shewhart Xbar-R with phases.
Variable control chart with WECO rules and stratification.
Process capability Capability indices and tolerance.
Cp, Cpk, Pp, Ppk with capability plots.
Pareto Defect analysis with stratification.
Pareto chart sorted by frequency with cumulative line.
Standard
Distribution Newcomb’s speed of light, 64 observations.
Descriptive statistics, histogram, box plot, Q-Q plot, Shapiro-Wilk, one-sample t-test.
Compare groups Y by brand, 7 groups.
One-way ANOVA, Tukey-Kramer all-pairs, Mean-Mean scatter plot.
