Method validation software for clinical laboratories and IVD manufacturers 11 CLSI protocols using current guideline versions in a single validated package — precision, linearity, detection capability, method comparison, reference intervals, and diagnostic performance.

Method validation covers a lot of ground. IVD manufacturers need to establish precision, linearity, bias, and detection capability during development, demonstrate method comparability with a predicate, establish reference intervals and diagnostic accuracy for product labelling, and produce the statistical evidence for a 510(k) submission or CE-IVD technical file. Clinical laboratories need to verify that a new analyser or reagent system meets manufacturer claims before it goes into clinical use, establish or verify reference intervals for their patient population, and demonstrate compliance during ISO 15189, CLIA, or CAP inspections. Both audiences need the same statistical rigour — the difference is regulatory context, not analytical depth.

Analyse-it implements 11 CLSI protocols using current guideline versions. Precision studies with flexible nested designs per EP05-A3. Linearity evaluation per EP06-A. Interference testing per EP10-A3-AMD. Verification against manufacturer claims per EP15-A3. Detection capability — LoB, LoD, and LoQ — per EP17-A2. Method comparison using Passing-Bablok, Deming, Weighted Deming, OLS, Weighted OLS, and Bland-Altman per EP09-A3, with bias at clinical decision points, replicate support, interval partitioning, and total analytical error estimation per EP21-A. Reference intervals using parametric, non-parametric, robust, bootstrap, and Harrell-Davis methods per EP28-A3C, with partitioning and transfer/verification. Diagnostic performance with ROC curves, AUC comparison, and qualitative test evaluation per EP24-A2 and EP12-A2.

The practical value of having all of this in one package is not just convenience — it is continuity. A method validation project moves through measurement system characterisation, method comparison, reference interval establishment, and diagnostic performance evaluation. Each stage informs the next. Having the entire workflow in one tool, on the same data, in the same workbook means the results are consistent, the audit trail is clear, and the output can go directly to regulatory affairs or the accreditation file without reformatting or reconstruction.

Scientists at Abbott, Roche, Thermo Fisher, Siemens Healthineers, and most of the world's leading IVD manufacturers have relied on Analyse-it for over 30 years. So have clinical laboratories running verification studies, reference interval programmes, and method changeovers at hospitals and reference laboratories worldwide.