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.
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. Partition analysis to a measuring interval. 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 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.
Seen in the field
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 measuring interval
When a single regression across the full range is inappropriate, partition the data to separate measuring intervals with their own analysis. 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.
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