Diagnostics › Method comparison

Commutability assessment

Assesses whether a reference or QC material behaves like a patient sample, by checking if it falls inside the prediction interval of the patient-sample method-comparison regression.

What is Commutability assessment?

Reference materials and controls are only trustworthy if they behave the way real patient samples do across two methods — a property called commutability. A non-commutable material can show method differences that patient samples never would (a matrix effect), invalidating its use for calibration or QC harmonization.

The engine fits the patient-sample regression (method X vs method Y) and its 95% prediction interval, then checks each reference/QC material's (X, Y) point. A material inside the interval is commutable; one outside behaves differently from patient samples.

When should I use Commutability assessment?

  • Qualifying reference materials, calibrators, or EQA/PT materials for use across methods.
  • Investigating a control that flags on one method but not another.

What data does it need?

Patient-sample measurements by method X and method Y (paired), plus the reference material's measurements by method X and Y.

What does it report?

The patient-sample regression + residual SD, and for each material its predicted value, the 95% prediction interval, and a commutable / not-commutable verdict.

What does it assume?

  • Enough patient samples spanning the range to define the relationship.
  • Approximately linear method relationship with roughly constant scatter.

Formula

Commutable ⇔ material's Y within ŷ ± t·s·√(1 + 1/n + (x₀−x̄)²/Sₓₓ)

How do I interpret the result?

A non-commutable material must not be used to transfer calibration or to judge agreement between the two methods — the observed difference is an artifact of the material, not a real method bias. Assess commutability before drawing method-comparison conclusions from processed materials.

See also

References

  • CLSI EP14-A3. Evaluation of Commutability of Processed Samples.
  • Miller et al. (2018). Commutability limitations. Clin Chem 64(3).