Analyse-it Method Validation Edition Validate and verify your analytical and diagnostic methods.

Meet the demands of regulatory compliance. With comprehensive validation and verification of your analytical and diagnostic methods.

Analyse-it Method Validation Edition helps you confirm that your measurement procedures are fit for purpose.

It's ideal for:

  • ISO/IEC 17025 accredited testing and calibration laboratories
  • ISO 15189 accredited medical laboratories
  • CLIA '88 regulated medical laboratories
  • FDA 510(k) submissions for in-vitro diagnostic device manufacturers

With Analyse-it Method Validation Edition, you can:

  • Validate or verify analytical performance characteristics (precision, trueness, linearity, interferences, detection capability) of a measurement procedure to ensure they meet requirements for intended use or manufacturer's claims.
  • Compare methods to establish the real-world performance of a method against a reference method, or ensure comparability between two methods when making changes.
  • Evaluate the diagnostic ability of a test to discriminate between two outcomes and compare test performance to find the most effective one.
  • Establish a reference interval for a population of healthy individuals. Or verify that existing intervals are transferable between laboratories or measurement procedures.
  • 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

What Analyse-it is? Read more...

What is Analyse-it?

Analyse-it brings powerful statistical analysis and data visualisation into Microsoft Excel. All the statistical analysis you need, in an application you already know. There's no locked-in file format. No need to transfer data from one system to another. And no learning curve. Just the tools Excel is missing. The ones that make powerful analysis easier.

Capable. Not complicated.

There's no avoiding it - statistics is complicated. But that doesn't mean you should have to struggle with an unwieldy, hard to use application.

Analyse-it makes things easier, with:

  • An intuitive user interface, built on the familiar foundation of Microsoft Excel
  • A logical task-based workflow that makes sense to those of us that aren't programmers or full-time statisticians
  • Plain English documentation that's easy to understand even if your knowledge is a bit rusty
  • High quality reports and charts so you can present your findings straight away

And at the same time, Analyse-it is capable of complex analysis built on the very latest best practices and using accurate algorithms – not simple techniques intended for hand calculation.

So you can spend your brainpower where it counts - on your analysis and your findings.

Statistical analysis. Accurate and reliable.

Microsoft Excel isn't up to the job of statistical analysis. Its built-in functions just aren't built for accuracy. So we don't use a single one.

Instead, Analyse-it handles all of your 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.

Validation. 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, and 2013.

What's more, validation tests are run automatically after every change to the software. So you can be confident your work is correct. And stays 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 we’re here for extra help, aiming to answer your queries within 24 hours.

Built for 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).

So we've included extensive support for 11 of those protocols:

 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

Software you can trust.

We've been involved in method validation for more than 15 years. We've 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 some of the top ten IVDs. And how we've been able to save them time with extensive statistical analysis for method validation in an accessible package.


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.

Technical specification

Method comparison
  • Deming regression
  • Weighted Deming regression
  • Passing Bablok regression
  • Ordinary linear regression
  • Weighted linear regression
  • Scatter plot with fit
  • Bland-Altman difference plot with limits of agreement
  • Mountain plot
  • Test no difference between methods
  • Test bias against manufacturer claim
  • Test equivalence of methods
  • Establish bias at decision points
    Qualitative
    • Kappa
    • Weighted Kappa
    Precision
    • Up to 2 factors such as day, run, laboratory
    • Repeatability
    • Intermediate precision
    • Reproducibility
    • Test against manufacturer claim
    • Precision profile over many levels
    Linearity
    • Emancipator-Kroll stepwise polynomial regression
    • Lack of fit test
    • Nonlinearity at each level
    • Recovery at each level
    • Difference plot of nonlinearity
    • Test equivalence of nonlinearity
    Reference interval
    • Parametric
    • Nonparametric
    • Harrell-Davis
    • Bootstrap
    • Robust Biweight
    • Box-Cox and other transformations
    Diagnostic performance ROC
    • ROC plot (compare upto 10 curves)
    • Area under curve
    • Test area under curve
    • DeLong DeLong Clarke-Pearson difference between curves
    • Decision plot to incorporate prevalence and costs.
    • Test equality, equivalence, non-inferiority between curves
    • Estimate false positive fraction (FPF) at fixed sensitivity, sensitivity at fixed FPF, and sensitivity/FPF at fixed cut-off.
    • Find optimal decision threshold based on costs.
    Qualitative
    • Sensitivity
    • Specificity
    • Predictive value +/-
    • Likelihood ratio +/-
    • Odds ratio
    • Youden's J
    • Compare sensitivity and specificity of 2 independent or correlated tests.
    The following features are included from the Analyse-it Standard edition
    Descriptive statistics
    • Mean, Variance, SD, Skewness, Kurtosis
    • Median, Minimum, Maximum, Range, IQR
    • Quantiles
    • Frequency table
    • Contingency table
    • Correlation coefficient
    Modeling & regression Linear Fits
    • Simple linear regression
    • Polynomial regression (2nd to 6th order)
    • Logarithmic regression
    • Exponential regression
    • Power regression
    • Multiple linear regression
    • Advanced models with simple, crossed, polynomial and factorial terms, with categorical explanatory variables coded as dummy variables
    Other Fits
    • Binary logistic regression
    • Leverage plot
    • Residual plot
    • Outlier and Influence plot
    • Standardized and Studentzied residuals
    • Cook's D
    • Test effect of each term
    • Test effect of model
    • Predict Y for X
    • Lack of fit test for simple regression models
    • Save model variables back to the dataset: Fitted Y, Residuals, Standardized Residuals, Studentized Residuals, Leverage, Cook's Influence.
    Multivariate Correlation / Association
    • Pearson r
    • Fisher Z confidence interval for Pearson r
    • Pearson test
    • Spearman rs
    • Kendall tau
    • Samara-Randles confidence interval for Kendall tau
    • Kendall test
    PCA
    • Classic Gabriel bi-plot
    • Gower-Hand bi-plot
    • Correlation mono-plot
    • Scree plot
    • Eigenvalues / Eigenvectors
    Common Factor Analysis
    • Maximum likelihood factor extraction
    • Factor pattern / structure matrices
    • 12 factor rotations including Varimax, Oblimin
    Hypothesis tests Location
    • Z-test (one, two, paired)
    • Student t-test (one, two, paired)
    • Welch t-test
    • Wilcoxon
    • Wilcoxon-Mann-Whitney
    • Sign
    • ANOVA
    • Repeated measured ANOVA
    • Welch ANOVA
    • Kruskal-Wallis
    • Friedman
    Dispersion / Homogeneity of variance
    • X2
    • Fisher F-test
    • Bartlett
    • Levene
    • Brown-Forsythe
    Normality
    • Shapiro-Wilk
    • Anderson-Darling
    • Kolmogorov-Smirnov
    Proportions
    • Binomial exact
    • McNemar-Mosteller exact
    • Fisher exact
    • Pearson X2
    • Score Z
    • Likelihood ratio G2
    Estimators Location
    • Mean
    • Median
    • Hodges-Lehmann pseudo-median
    • t-based confidence interval for mean
    • Z-based confidence interval for mean
    • Thompson-Savur confidence interval for median
    • Tukey confidence interval for Hodges-Lehmann pseudo-median
    • Mean difference
    • t-based confidence interval for mean difference
    • Z-based confidence interval for mean difference
    • Welch-Satterthwaite t-based confidence interval for mean difference
    • Hodges-Lehmann location shift
    • Tukey confidence interval for Hodges-Lehmann location shift
    • Multiple comparisons: Tukey-Kramer, Dunnett, Hsu (with best), Scheffe (all contrasts), Steel (non-parametric against control), Dwass-Steel-Critchlow-Fligner (non-parametric all pairs), Wilcoxon (individual comparisons)
    Dispersion
    • Variance
    • X2-based confidence interval for variance
    • Variance ratio
    • F-based confidence interval for variance ratio
    Proportions
    • Proportion
    • Odds
    • Clopper-Pearson exact confidence interval for proportion
    • Wilson score confidence interval for proportion
    • Proportion difference (risk difference)
    • Proportion ratio (risk ratio)
    • Odds ratio
    • Miettinen-Nurminen score confidence interval for proportion difference / proportion ratio / odds-ratio
    • Newcombe score confidence interval for proportion difference
    • Conditional exact confidence interval for odds ratio
    Correlation
    • Pearson r
    • Fisher Z confidence interval for Pearson r
    • Spearman rs
    • Kendall tau
    • Samara-Randles confidence interval for Kendall tau
    Plots
    • Histogram
    • Dot plot
    • Box plot
    • Mean error bar plot
    • CDF plot
    • Normal Q-Q plot
    • Scatter plot
    • Scatter plot matrix
    • Difference plot
    • Mean-Mean scatter plot for visualizing multiple comparisons.
    • Frequency plot
    • Pie frequency plot
    • Mosaic plot
    • Grouped frequency plot
    • Stacked frequency plot

    System requirements

    • Microsoft Excel 2007, 2010, 2013 & 2016 (32- and 64-bit)
    • Microsoft Windows XP, Vista, 7, 8, 10, Server 2003, 2008, 2012, & 2016
    • 2GB RAM minimum recommended
    • 35MB disk space