Analyse-it® Method Evaluation Edition

Method validation software for IVDs, Clinical Laboratories and Researchers to validate, verify, and demonstrate analytical and diagnostic method performance.

Simple single-run precision is provided for a preliminary precision evaluation.

For in-depth analysis CLSI EP5 is supported to examine precision within a single run, precision between runs (for example morning and afternoon), precision over a number of days, and precision over the reportable range (often near the upper and lower) of analyte concentrations.

Finally precision can be evaluated over a number of concentrations, for example near medicial decision levels or at the extremes of the reportable range, to ensure precision is within required performance limits.

  • Determine a simple precision estimate
    Calculate SD or CV(%) precision from a single run.
  • Determine total precision & repeatability
    Satisifies CLSI EP5-A2. Calculates Total precision (within-device/laboratory) and Repeatability (within-run) SD or CV(%) from 1- or 2- runs over many days, or over a range of analyte concentrations.
    See an example Analyse-it report for CLSI EP5-A2 2-run, 20-day precision
  • Demonstrate precision is within allowable goal or meets manufacturer's claim
    Satisfies CLSI EP5-A2 & EP15-A2. Express allowable precision as absolute/percentage of concentration, or as Random Error% of Total Allowable Error (TAe).
  • Visually assess precision
    A precision plot shows the scatter of observations.
    See example Precision plot for 2-runs, observed in duplicate