Analyse-it statistical analysis software Ultimate Edition Combining all the Analyse-it statistical analysis, method validation, and statistical process control tools in a single package.


The leading software package for statistical analysis, method validation, and statistical process control for over 20-years.

Analyse-it is developed for and is in use at thousands of ISO/IEC 17025 accredited testing and calibration laboratories, ISO 15189 accredited medical laboratories, CLIA '88 regulated medical laboratories, and IVD manufacturers for development, support, product labeling and FDA 510(k) submissions.

  • 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.
    Principle Scientist, Product Development
    Biosite / Inverness Medical Innovations
  • 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
  • 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

All the features of the
Analyse-it Method Validation Edition...

Built for CLSI protocols

The latest Clinical and Laboratory Standards Institute (CLSI) method validation protocols are recognized by the College of American Pathologists (CAP), The Joint Commission, and the US Food and Drug Administration (FDA).

That's why we included extensive support for 11 CLSI protocols

Evaluation of Precision of Quantitative Measurement Procedures
User Verification of Precision and Estimation of Bias
Evaluation of the Linearity of Quantitative Measurement Procedures
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
Estimation of Total Analytical Error for Clinical Laboratory Methods
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures
 EP24-A2 (Replaces GP10-A)
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
User Protocol for Evaluation of Qualitative Test Performance
 EP28-A3C (Formerly C28-A3C)
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
Evaluation of Commutability of Processed Samples

Validate and verify measurement system performance characteristics

It’s essential to ensure the performance characteristics (precision, trueness, linearity, interferences, detection capability) of a measurement procedure meet the requirements for intended use. Manufacturers (IVD companies) must establish performance during product development to feedback into the development process, for FDA 510k submissions and product marketing, and to support customers in the field. Laboratories must verify they can achieve the manufacturer's claimed performance during implementation of a new measurement system, during regulatory inspections (under the CLIA ’88 act), and as part of proficiency testing (PT) schemes. Measurement systems analysis (MSA) lets you determine all these important performance characteristics in one analysis.

  • measurement systems analysis
  • detection limit analysis

Examine diagnostic test performance to find the most effective

Rated best ROC curve software in Clinical Chemistry March 2003 vol. 49 no. 3 pg. 433-439, Analyse-it lets you establish and compare the ability of a diagnostic test to correctly diagnose patients. Explore how the test differentiates between positive and negative cases and explore optimum decision thresholds factoring in the costs of misdiagnosis.

diagnostic ability

Compare methods and evaluate the impact of making changes

When introducing a new measurement procedure you want to see how it stacks-up against your existing procedure or evaluate its performance against the gold-standard. Bland-Altman lets you see the agreement between methods and what effect the differences between methods might have on clinical interpretation. More advanced procedures like Deming regression and Passing-Bablok tell you the bias between methods, how medical decision points may be affected, and let you test if bias meets performance requirements.

method comparison

Establish reference intervals to make clinical diagnoses

Reference intervals are essential for clinicians to interpret results and make a diagnosis. As a laboratory it's your job to provide normal reference ranges they can rely on. With the widest range of methods available in any software package, the ability to partition the intervals by factors such as sex, age, ethnicity, Analyse-it makes it easy to establish reference ranges or transfer them to a new measurement procedure.

reference intervals

Analyze time-to-event data with survival analysis

Determining the time to an event, such as a patient death or component failure, is essential to evaluate performance of a treatment or component. Kaplan-Meier survival curves let you see and compare and test the difference between multiple survival functions. Proportional Hazards let you model the time-to-event data, including how factors such as Age, Sex, or other co-variates affect survival.

reference intervals

With all the features of the
Analyse-it Quality Control & Improvement Edition...

Bring processes under statistical control

Gain insight and improve process performance with Shewhart variable and attribute, CUSUM, and moving average control charts (EWMA & UWMA). Apply WECO, Nelson and Montgomery rules to help identify possible out of control situations. Use stratification to gain further insight into problems and spot trends and patterns. And when you've implemented improvements, or made other changes, phases let you track performance before and after so you can ensure improvements have been made and are sustained.

shewhart control charts

Ensure products are meeting end-user specifications

Determine process capability indices for process performance to ensure you deliver products that meet your customers’ requirements. A happy customer means fewer rejected goods and service complaints, improving your business and lowering costs.

process capability

Identify improvements that will reap the most rewards

Pareto analysis helps you quickly identify commonly occurring defects so you can focus your efforts making improvements that will reap the most rewards. Stratification lets you break-down defects so you can identify contributing factors, such as an operator that is influencing defect rates, or look at defects before and after process improvements to ensure the changes are reducing defects.

pareto chart analysis
Read about the Standard Edition...

Plus it includes the
Analyse-it statistics software Standard Edition...

All the features from the Analyse-it Standard Edition are included so you can improve processes and products by identifying solutions using hypothesis tests and model fitting techniques.

Integrated into Microsoft Excel, so it's easy to use...

That's right. Analyse-it integrates into Microsoft Excel 2007, 2010, 2013, 2016, 2019 and Office 365 for Microsoft Windows. There's virtually no learning curve, and the intuitive user interface and logical task-based workflow makes sense to those of us that aren’t programmers or full-time statisticians.

All your data and results are kept in Excel workbooks, making it easy to collaborate and share them with colleagues, and meaning there's no locked-in file format.

statistical add-in for Excel

Software you can trust

We've developed software for statistical analysis and method validation for more than 25 years, and popularized statistical procedures that have since been adopted into method validation standards and guidelines.

But it's our customers that matter - the independent laboratories, regulatory agencies, and many of the world's top ten IVD companies. Check out the latest reviews on Capterra, in the meantime here are a few of our customers...

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Case study

Analyse-it® Reduces Method Validation steps at National Reference Laboratory

With Analyse-it, I pull in the data and quickly analyse it, and then prepare figures for manuscripts right there. From the beginning of the project to completion, using one application saves me probably a day's worth of time.

Case study

Analyse-it® Cuts Project Time in Half at Swiss Laboratory

Analyse-it has a tremendous advantage in its ease of use. With other programs, you really have to study how to use them, but Analyse-it makes it so easy, and at the same time offers the advanced procedures we need like Weighted Deming regression.

Accurate and reliable

You might have heard Microsoft Excel isn't up to the job of statistical analysis. It isn't. The built-in functions just aren't built for accuracy. So we don't use a single one. Instead, Analyse-it handles all of the calculations internally, using reliable algorithms and IEEE 754 double floating point precision. And the results to prove it?

See Analyse-it's performance against the NIST-StRD.

Validated, tested at every stage

We've conducted thousands of tests to put Analyse-it through its paces. They cover all releases and service packs of Microsoft Excel 2007, 2010, 2013, 2016, 2019 and Office 365. What's more, validation tests are run automatically after every change to the software so you can be confident the statistics are correct. And stay correct.

See our development & validation process.

Dependable support

No need to resort to old textbooks. Analyse-it includes detailed help that’s written in plain English. And if you get stuck we’re here for extra help - aiming to answer your queries within 24 hours.

Take a look for yourself. Real-world example analyses using Analyse-it...

Included from the Analyse-it Method Validation edition...

Included from the Analyse-it Quality Control & Improvement edition...

Included from the Analyse-it Standard edition...

Technical specification

System requirements
  • Microsoft Excel 2007, 2010, 2013, 2016, 2019 and Office 365 (32- and 64-bit)
  • Microsoft Windows Vista, 7, 8, 10, 11, Server 2003, 2008, 2012, & 2016
  • 2GB RAM minimum recommended
  • 80MB disk space
Survival function new in v6.10

Included from the Analyse-it Method Validation edition...

Method comparison
Quantitative methods
Qualitative methods
  • Proportion in positive agreement / negative agreement with Clopper-Pearson exact or Wilson score confidence intervals
  • Kappa and Weighted Kappa for chance-corrected agreement with Wald Z confidence interval
  • Kappa test for agreement
Measurement Systems Analysis (MSA)
Bias / Trueness new in v4.00
Reference interval
Diagnostic performance
  • Diagnostic performance for 1 test, 2 paired tests, or 2 independent tests/groups
  • Sensitivity/Specificity with Clopper-Pearson exact or Wilson score confidence interval
  • Likelihood ratios with Miettinen-Nurminen score confidence interval
  • Predictive values with Mercado-Wald logit confidence interval
  • Odds ratio, and Youden's index
  • Mosaic plot of outcomes
  • Difference between sensitivity/specificity with Newcombe or Tango score confidence intervals
  • McNemar-Mosteller exact, Fisher exact, and Score Z test for equality of sensitivity/specificity
  • Supports CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance

Included from the Analyse-it Quality Control & Improvement edition...

Process Control
Process Capability
Pareto analysis

Included from the Analyse-it Standard edition...

Compare groups
Compare pairs
Contingency tables
2x2 related tables
2x2 tables
Fit model – ANOVA / ANCOVA / Regression
MSA (Measurement System Analysis) software Measurement System Analysis software Reference interval software ROC curve software Sensitivity & Specificity analysis software Method comparison software Bland-Altman software Deming regression software Passing Bablok software Method Validation software Statistical Process Control (SPC) statistical software SPC software Six Sigma statistical software Excel SPC addin Excel Statistical Process Control (SPC) add-in Pareto plot software software for Excel Pareto plot add-in software for Excel Pareto chart add-in software for Excel Control chart Excel add-in Process Capability statistical software Capability Analysis add-in software Principal Component analysis addin software Excel PCA add-in Excel ANOVA add-in ANCOVA software Multiple Regression analysis add-in software Multiple Linear Regression statistical software Excel model fitting software Excel statistics analysis addin software Excel statistical analysis addin software Statistics software Statistical analysis software
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