Analyse-it blog The latest news on new features and software releases.

23-Jun-2015 Analyse-it 4.0 released: Support for CLSI guidelines, and Measurement Systems Analysis

Today we released version 4.0 of the Analyse-it Method Validation edition. This is a major new release with many new features and improvements.

Support for 10 of the latest CLSI EP guidelines

The latest release of the Analyse-it Method Validation edition now supports 10 of the latest CLSI evaluation protocol (EP) guidelines. CLSI guidelines are world-renowned and are recognized by the College of American Pathologists (CAP), The Joint Commission, and the US Food and Drug Administration (FDA).

Analyse-it has been a driving force in the adoption of statistics in method validation for over 15 years, has influenced many recommendations, and is the only software available with such extensive coverage for the latest CLSI guideles.

CLSI guidelines supported in version 4.0 include:

EP05-A3
Evaluation of Precision of Quantitative Measurement Procedures
EP06-A
Evaluation of the Linearity of Quantitative Measurement Procedures
EP09-A3
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
EP10-A3-AMD
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures
EP12-A2
User Protocol for Evaluation of Qualitative Test Performance
EP15-A3
User Verification of Precision and Estimation of Bias
EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
EP21-A
Estimation of Total Analytical Error for Clinical Laboratory Methods
EP24-A2 (Replaces GP10-A)
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
EP28-A3C (Formerly C28-A3C)
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory

Measurement Systems Analysis (MSA)

Measurement Systems Analysis (MSA) is a new feature in version 4.0. MSA unifies precision and linearity, which were available in earlier versions of Analyse-it, but also includes trueness (bias) and detection capability so you can establish the limit of blank (LoB) and limit of detection (LoD). The unification of these analyses in MSA lets you dig deep to examine and understand the performance characteristics of a measurement procedure.

Partition Method Comparison and Reference Interval analyses

A major improvement in version 4.0 is the ability to split a method comparison analysis into specific measuring intervals and apply a different analysis. For example, you might split the analysis into two measuring intervals: samples <1ug/L, and those above. For <1ug/L the relationship between measurements might be different from those >1 ug/L, so you can apply different fits and goals to each measuring interval to see how the methods compare.

Similarly, for reference intervals you can apply partitioning factors to generate reference intervals for different sub-groups. For example, you might apply partitioning factors sex and age group so you can determine reference intervals for age groups 0-20, 20-35, 35-50, and 50+ for male / female subjects. For each subgroup you can change how the reference interval is calculated, for example using the robust reference interval calculation for a sub-group with very few subjects.

Availability

If you already have a licence for Analyse-it, and you have active maintenance (access to software updates), you can download the latest version now. If maintenance on your licence has lapsed, now is a good time to renew maintenance to get this update and future updates before the price increase (see below).

To download the update, check whether you have maintenance, or to renew maintenance, see:

/support/download

If you are new to Analyse-it you can download a free 30-day trial at:

/products/method-validation/try

Pricing and licensing changes from 7th July 2015

The cost of a 1-user perpetual licence for the Analyse-it Method Validation will increase from US$699 to US$749, and the cost of a 1 floating-user perpetual licence will crease from US$1239 to US$1329 from the 7th July 2015. Since maintenance is based on a percentage of the licence price, the 1-year maintenance renewal price for a 1-user perpetual licence will increase slightly from US$69.90 to US$74.90.

We will also be trialling a new option to purchase a 1-year annual subscription for the Analyse-it Method Validation edition from the 7th July 2015. The cost will be US$ 449 for 1-year and includes all software updates released within the year. At the end of the year you can renew your licence to continue using the software, or let the licence lapse if you no longer need it.

Change summary

Finally, below is a list of the major changes and improvements in version 4.0.

Reference interval

  • Partition factors for separate reference interval analysis of sub-groups.
  • Additional transformation functions: Manly exponential, 2-stage Exponential/Modulus transformation.
  • Normal MVUE quantile estimator for reference limits.

Diagnostic performance

  • Bi-Histogram and dot-pot of the distribution of positive/negative cases.

Method comparison

  • Adjust measuring interval to a linear range and extrapolate fits beyond the data to the measuring interval.
  • Partition into measuring intervals, with different relationships (e.g. constant / relative differences or variances) for each measuring interval.

Linearity

  • Improved report and plots.
  • Integrated into MSA to allow unified approach to evaluation of other components of error.

Precision

  • Improved report and plots.
  • Precision profile variance function fits with a choice of 7 fits, including Sadler 3-parameter functions.
  • Limit of quantitation via prediction from CV% on precision profile plot.

Trueness NEW

  • Estimate bias with reference materials or PT/EQA material.

Detection capability NEW

  • Estimate the decision level critical value (LoB) using parametric and non-parametric estimator on blank material or via the precision profile variance function.
  • Estimate the detection limit (LoD) using non-blank material or via the precision profile variance function.

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