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Analyse-it Method Validation statisics software Method Validation Edition Validate and verify your analytical and diagnostic methods to meet the demands of regulatory compliance.

analytical and diagnostic method validation in Excel

The leading software package for method validation 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

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

CLSI
 EP05-A3
Evaluation of Precision of Quantitative Measurement Procedures
 EP15-A3
User Verification of Precision and Estimation of Bias
 EP06-A
Evaluation of the Linearity of Quantitative Measurement Procedures
 EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
 EP09-A3
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
 EP21-A
Estimation of Total Analytical Error for Clinical Laboratory Methods
 EP10-A3-AMD
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
 EP12-A2
User Protocol for Evaluation of Qualitative Test Performance
 EP28-A3C (Formerly C28-A3C)
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
 EP14-A3
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 statistical software for Excel
  • detection capability software

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 performance and ROC curve

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.

Bland-Altman, Deming, Passing-bablok 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
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 analysis software add-in for Microsoft Excel

Software you can trust

We've developed software for 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.

Technical specification

System requirements
  • Microsoft Excel 2007, 2010, 2013, 2016, 2019 and Office 365 (32- and 64-bit)
  • Microsoft Windows Vista, 7, 8, 10, Server 2003, 2008, 2012, & 2016
  • 2GB RAM minimum recommended
  • 80MB disk space
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
Linearity
Reference interval
Diagnostic performance
Qualitative
  • 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 Standard edition...

Distribution
Compare groups
Compare pairs
Contingency tables
2x2 related tables
2x2 tables
Fit model – ANOVA / ANCOVA / Regression
Multivariate
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