Measurement System Analysis Software for IVD and Laboratory Method Validation
Complete, validated implementation of CLSI EP05, EP06, EP10, EP15, and EP17 — establish and verify precision, bias, linearity, and detection capability for your measurement system, all within Excel.
Try free for 15 days — no credit card required
Trusted by 75,000 scientists at most of the top-10 IVD manufacturers, and at thousands of ISO 15189, ISO/IEC 17025, and CLIA-regulated laboratories worldwide for over 30 years.
Every performance characteristic in one package
Precision, bias, trueness, linearity, and detection capability — all implemented to the relevant CLSI guideline, all in a single validated package. No switching between tools or reconciling results from different sources.
Results you can stand behind
Every calculation runs in Analyse-it’s own validated engine — no Excel formulas, no third-party functions. Validated against CLSI reference datasets before every release. Defensible in a 510(k), CE-IVD submission, CAP inspection, or ISO 15189 audit.
Your data never leaves your environment
Analyse-it runs entirely on your PC. Nothing is sent to a server, nothing is exposed to a cloud service - important when working with pre-submission or patient-adjacent data under data governance constraints.
Establishing and verifying measurement system performance is a requirement across the full spectrum of analytical and diagnostic work. IVD manufacturers must characterise precision, linearity, bias, and detection capability during development — to inform design decisions, support product labelling, and satisfy regulatory submissions. Medical and accredited laboratories must verify they can meet those claimed performance characteristics before a new measurement system goes into clinical or analytical use, and demonstrate continued compliance under CLIA, CAP, ISO 15189, or ISO/IEC 17025.
The CLSI EP guidelines define the standard approaches for each of these studies. Analyse-it implements all of them — EP05 for precision, EP06 for linearity, EP10 for preliminary evaluation, EP15 for user verification of precision and trueness, EP17 for detection capability — in a single validated package, inside Excel. Every calculation is performed by Analyse-it’s own engine. No Excel formulas that can silently break, no community spreadsheets you can’t defend. Results are validated against the example datasets published in the CLSI guidelines before every release.
Scientists at Abbott, Roche, Thermo Fisher, and most of the world’s leading IVD manufacturers have relied on it for over 30 years — as have laboratory directors and scientists at thousands of ISO 15189, ISO/IEC 17025, and CLIA-regulated laboratories worldwide.
Seen in the field
What's included
-
Precision — EP05-A3 and EP15-A3
Evaluate repeatability and reproducibility with flexible balanced and unbalanced designs — up to three nested random factors (day, run, laboratory) without fixed run/day constraints, so your study design drives the analysis. Verify precision against manufacturer claims or your own allowable goals under EP15-A3. Precision profile and variance function fitting included for characterising precision across the measuring interval.
-
Bias and trueness — EP15-A3 and EP10-A3
Estimate bias with confidence intervals, test for equality or equivalence against allowable bias goals, and verify trueness against assigned values. Supports both full EP15-A3 user verification studies and EP10-A3 preliminary evaluations to screen for bias early in development.
-
Linearity — EP06-A and EP10-A3
Determine whether the measurement response is linear across the full measuring interval. Polynomial model fitting up to 5th order, weighted models for non-constant precision, and the full set of EP06-A statistical tests for linearity and nonlinearity against predefined performance goals. Adjust the measuring interval to find the linear range when the full range is nonlinear.
-
Detection capability — EP17-A2
Estimate limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) from blank and low-level materials, precision-profile variance functions, or Probit regression. EP17-A2 compliant throughout, so your detection capability claims rest on a documented, defensible statistical method.
-
Publication-ready reports
Generate clean, formatted reports directly from your analysis. No reformatting, no copy-paste errors, no additional tools required — whether the output is going into a regulatory dossier, a 510(k) submission, or a laboratory validation file.
-
Validated before every release
Every calculation is performed by Analyse-it’s own engine — no Excel formulas or functions. Results are validated against the example datasets in the relevant CLSI guidelines before every release, so you can trust what you’re signing off on. See our development and validation process →
-
Your data never leaves your environment
Analyse-it runs locally on your PC. No cloud processing, no data transmission, no exposure risk — your pre-submission and instrument data stays where it belongs.
-
More than just measurement system analysis
The Method Validation edition also covers method comparison — Bland–Altman, Passing–Bablok, Deming, Weighted Deming, OLS, and Weighted OLS, all following CLSI EP09-A3. Plus reference intervals (EP28), diagnostic performance (EP24, EP12), and total analytical error (EP21). One validated package for your entire method validation workflow.
Join 75,000 scientists who rely on Analyse-it. No credit card required. Full functionality from day one.
Try free for 15 days — no credit card required
