Method comparison

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

Analyse-it includes a wide range of industry-recognised method comparison procedures.

In-vitro diagnostic laboratories can validate against a gold standard to satisfy CLSI EP9. Laboratories implementing a new method can verify or demonstrate accuracy to satisfy CLIA, or compare against their existing method to verify transference of reference intervals.

• Visually assess methods with difference plot, scatter plot, and repeatability plots
  Satisfies CLSI EP9-A2, EP15-A2, EP21-A. Includes Bland-Altman bias plots, Hyltoft Petersen and CLSI difference plots, showing absolute/percentage differences, bias and limits of agreement.
  
  See an example Analyse-it report of the Bland Altman limits of agreement method
  Data from: Bland JM, Altman DG. (1986). Statistical methods for assessing agreement between two methods of clinical measurement. Lancet, i, 307-310.
  See example Bland-Altman difference plot showing bias and limits of agreement
  See example Scatter plot with identity (agreement) line
  See example Histogram of differences between methods
  See example Repeatability plot
• Establish analytical accuracy
  Satisfies CLSI EP9-A2, and includes Linear regression, Weighted Linear regression (for non-constant variance), Deming regression, Weighted Deming regression (for non-constant variance) and Passing-Bablok regression (includes both Passing-Bablok methods, for method comparison & conversion) fits.
  
  See an example Analyse-it Linear method comparison
• Demonstrate accuracy is within allowable goal or meets manufacturer's claim
  Satisfies CLSI EP15-A2. Express allowable bias as absolute/percentage of concentration, or as Systematic Error% of Total Allowable Error (TAe).
• Examine bias at important clinical decision levels
• Establish accuracy of qualitative methods
  Satisfies CLSI EP12-A.