Passing-Bablok regression software for method comparison The complete CLSI EP09-A3 Passing-Bablok implementation — bias at clinical decision points, replicate support, interval partitioning, and non-constant precision handling.
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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.
Bias at clinical decision points
Test equality and equivalence at the thresholds clinicians act on — not just across the measurement range. Confirm that bias is within acceptable limits at each concentration that changes patient management, exactly as EP09-A3 specifies.
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.
Most Passing-Bablok implementations cover the basics — slope, intercept, a confidence interval. But CLSI EP09-A3 requires substantially more. Bias estimation at specific clinical decision points rather than across the range. Proper handling of replicate measurements with correct within-subject variance estimation. The ability to partition the measuring range when precision is non-constant, applying separate analyses to each interval rather than forcing a single regression where the assumptions don't hold. Spreadsheet templates widely circulated in laboratories stop well short of this, and so do most commercial tools.
Analyse-it covers the full EP09-A3 protocol. Slope and intercept with confidence intervals using both normal approximation and bootstrap methods. CUSUM linearity test with exact p-values to verify the linear model assumption holds. Equality and equivalence hypothesis tests at each decision point. Interval partitioning by sex, age, instrument, or any other factor. Replicate measurements handled correctly, not approximated. Total analytical error estimation per EP21, combining bias with imprecision against the allowable total error requirement.
Passing-Bablok sits alongside Deming, Weighted Deming, OLS, Weighted OLS, and Bland-Altman in the same method comparison analysis. Run Passing-Bablok to get the robust bias estimate, check with Bland-Altman to see the distribution of differences, switch to Weighted Deming if precision varies across the range — all on the same data, in the same workbook, without re-entering anything. Change a decision point, add a partition factor, re-run immediately.
Scientists at Abbott, Roche, Thermo Fisher, and most of the world's leading IVD manufacturers have relied on Analyse-it for over 30 years. If the method comparison has to be defensible at regulatory submission or laboratory inspection, they use Analyse-it.
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What's included
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Slope and intercept with bootstrap and normal CIs
Both the original 1983 and 1988 Passing-Bablok methods. Confidence intervals via normal approximation and bootstrap. CUSUM linearity test with exact p-values to verify the linear model assumption before committing to the regression interpretation.
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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 precision varies across the measuring range, partition the data by one or more factors and apply separate regression 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
Passing-Bablok 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), method comparison (EP09-A3, EP21-A), 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
