Analyse-it® Method Evaluation Edition
Compare methods and establish, validate, verify, or demonstrate accuracy with Bland-Altman
bias plots, Deming regression, Passing-Bablok regression, CLSI EP9 & EP14 protocols
to meet FDA method validation requirements.
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.
- 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.
- 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.
What next?
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