Deming and Weighted Deming regression software for method comparison Deming and Weighted Deming regression per CLSI EP09-A3 — with bias at clinical decision points, non-constant precision handling, replicate support, and interval partitioning.
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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.
Deming and Weighted Deming in one analysis
When precision is constant, Deming regression gives you the correct bias estimate. When precision varies across the measuring range, Weighted Deming accounts for it. Both are available in the same analysis — switch between them and see the effect immediately.
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.
Choosing between Deming and Weighted Deming regression depends on whether precision is constant across the measuring range — and getting this wrong invalidates the bias estimate. Standard Deming regression assumes a constant variance ratio between methods. When that assumption holds, it gives a more efficient estimate than Passing-Bablok. But for many clinical assays, precision worsens at higher concentrations. In those cases, Weighted Deming regression accounts for the changing variance, producing bias estimates that are valid across the full measuring range. Most implementations offer one or the other; Analyse-it offers both in the same analysis, so you can compare the results directly and choose the appropriate model.
Analyse-it's Deming implementation covers the full CLSI EP09-A3 protocol. Slope and intercept with confidence intervals. Bias prediction at specific clinical decision points, with equality and equivalence hypothesis tests at each threshold. Replicate measurements handled correctly with proper within-subject variance estimation. Interval partitioning by sex, age, instrument, or any other factor when a single regression across the full range is inappropriate. Total analytical error estimation per EP21-A, combining the bias estimate with imprecision against the allowable total error requirement.
Deming regression sits alongside Weighted Deming, Passing-Bablok, OLS, Weighted OLS, and Bland-Altman in the same method comparison analysis. Start with Deming, check the residuals for non-constant variance, switch to Weighted Deming if needed, compare with Passing-Bablok for a nonparametric confirmation, and inspect the Bland-Altman plot to see the distribution of differences — all on the same data, in the same workbook. 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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Choose the right regression for your data
Deming regression when precision is constant across the measuring range. Weighted Deming when precision varies. Both available in the same analysis per CLSI EP09-A3 — compare directly and select the model appropriate for your data.
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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 regression 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
Deming regression 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
