Release version 4.00.1

Analyse-it Method Validation edition, version 4.00

• Support for CLSI guidelines

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.