Analyse-it Method Validation Edition provides the statistical analysis you need to validate and verify analytical and diagnostic methods to meet the demands of regulatory compliance. With support for 11 CLSI protocols, it lets you:
• Validate or verify analytical performance characteristics (precision, trueness, linearity, interferences, detection capability) of a measurement procedure to ensure they meet requirements for intended use or manufacturer's claims.
• Compare methods to establish the real-world performance of a method against a reference method, or ensure comparability between two methods when making changes. Includes Deming, Weighted Deming, and Passing-Bablok regression, plus Bland-Altman limits of agreement.
• Evaluate the diagnostic ability of a test to discriminate between two outcomes and compare test performance to find the most effective one. Includes ROC curves and Delong-Delong Clarke Pearson curve comparisons.
• Establish a reference interval for a population of healthy individuals, or verify that existing intervals are transferable between laboratories or measurement procedures. Includes normal, quantile, robust bi-weight quantile, bootstrapped quantile, & Harrell-Davis quantile reference ranges.