We are receiving a lot of questions about relevant analyses in the Analyse-it Method Validation edition to help in evaluating new diagnostic tests in the fight against COVID-19. Below are some quick links that will help, but contact us if you have questions - we are working as normal.
Also see our latest blog post: Sensitivity/Specificity and The Importance of Predictive Values for a COVID-19 test
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.
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 guidelines.
CLSI guidelines supported in version 4.0 include:
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.
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.
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:
If you are new to Analyse-it you can download a free 30-day trial at:
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.
Finally, below is a list of the major changes and improvements in version 4.0.
Detection capability NEW
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