Method comparison software per CLSI EP09-A3 All six regression methods and Bland-Altman limits of agreement in a single analysis — Passing-Bablok, Deming, Weighted Deming, OLS, Weighted OLS, and Bland-Altman — with bias at clinical decision points, replicate support, interval partitioning, and total analytical error estimation per EP21-A.
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.
Six methods, one analysis
Passing-Bablok, Deming, Weighted Deming, OLS, Weighted OLS, and Bland-Altman limits of agreement — all available in the same analysis on the same data. Switch methods, compare results, and choose the approach appropriate for your data without re-entering anything.
Validated against CLSI EP09-A3 data
Every calculation runs in Analyse-it's own engine — no Excel formulas, no third-party functions. Results are validated against the example datasets published in the CLSI EP09-A3 guidelines before every release. Defensible in a 510(k), CE-IVD technical file, CAP inspection, or ISO 15189 audit.
Data stays in your facility
Analyse-it runs entirely within Microsoft Excel on your PC. No cloud processing, no data transmission — your pre-submission and patient-adjacent data stays within your facility under your data governance controls.
Method comparison is not a single analysis — it is a sequence of decisions. Is precision constant or does it vary across the measuring range? Are there enough data points for a nonparametric method, or is a parametric approach more appropriate? Is bias constant or proportional? Does the linear model assumption hold? Each answer changes which regression method is valid and what the bias estimate means. Most tools offer one or two methods and leave the choice to you. Analyse-it provides all six in the same analysis, so you can compare them directly and make that decision with evidence rather than assumption.
Analyse-it covers the full CLSI EP09-A3 method comparison protocol. Passing-Bablok for a robust nonparametric estimate when neither method is error-free. Deming regression when precision is constant and the variance ratio is known or estimated. Weighted Deming when precision varies across the range. OLS and Weighted OLS when one method can serve as a reference. Bland-Altman limits of agreement to see the distribution of differences — with constant or non-constant precision, mean or median bias, and confidence intervals on the limits. Every method supports bias prediction at clinical decision points, equality and equivalence hypothesis tests, replicate measurements with correct variance estimation, and interval partitioning by sex, age, instrument, or any other factor.
The practical workflow matters as much as the statistical methods. Run the Passing-Bablok regression to get a robust initial estimate. Check the CUSUM linearity test — if the linear assumption doesn't hold, partitioning may be needed. Switch to Deming or Weighted Deming for a parametric estimate and compare. Inspect the Bland-Altman plot to see how the differences distribute across the range. Test bias at the clinical decision points that matter. Estimate total analytical error per EP21-A by combining bias with imprecision. All in the same workbook, all updating immediately when you adjust the model.
Scientists at Abbott, Roche, Thermo Fisher, and most of the world's leading IVD manufacturers have relied on Analyse-it for method comparison studies for over 30 years — as have clinical laboratories running analyser verification before go-live, and researchers publishing agreement studies in peer-reviewed journals.
Seen in the field
What's included
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Quantify bias with the right regression for your data
Passing-Bablok for a robust nonparametric estimate. Deming and Weighted Deming for parametric estimation with constant or non-constant precision. OLS and Weighted OLS when one method serves as the reference. Slope and intercept with confidence intervals for all methods.
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See the distribution of differences with Bland-Altman
Mean and median bias with confidence intervals. Limits of agreement for constant precision (horizontal) and non-constant precision (V-shaped). Linear trend fit to detect proportional bias. Confidence intervals on the limits themselves.
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Confirm acceptable bias at clinical decision points
Predict mean bias at any clinical decision threshold. Equality and equivalence hypothesis tests at each point per CLSI EP09-A3 — confirm the difference between methods is within acceptable limits at the concentrations clinicians act on.
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Correct handling of replicate measurements
Handle singlicate, duplicate, and replicate measurements correctly. Within-subject variation is properly estimated and confidence intervals adjusted accordingly — not approximated by averaging replicates.
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Partition by measuring interval, sex, age, or instrument
When a single analysis across the full range is inappropriate, partition the data by one or more factors and apply separate analyses to each interval. Exactly as EP09-A3 specifies for non-constant precision.
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Determine whether total error meets your requirements
Estimate total analytical error per CLSI EP21-A by combining bias from the method comparison with imprecision of the test method. Assess whether total error falls within the allowable total error for each measurand.
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Validated engine you can defend at inspection
Every calculation runs in Analyse-it's own engine — no Excel formulas or third-party functions. Validated against the CLSI EP09-A3 published example datasets before every release. See the development and validation process.
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Part of the Method Validation edition
Method comparison is included in the Method Validation edition, which covers the full CLSI method validation workflow — measurement system analysis (EP05-A3, EP06-A, EP15-A3, EP17-A2), reference intervals (EP28-A3C), diagnostic performance (EP24-A2, EP12-A2), and total analytical error (EP21-A). One tool for everything your laboratory or IVD submission requires.
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.
Try free for 15 days — no credit card required
See all Method Validation features
Pricing and licensing
Reference lab case study
