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ISO 15189:2022 · Top-down MU

Uncertainty of Measurement (UoM) calculator for pathology labs

ISO 15189:2022 requires labs to estimate and review measurement uncertainty for quantitative results. QCnomics calculates UoM per analyte from your own internal QC data — no spreadsheets.

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What is Uncertainty of Measurement?

Uncertainty of Measurement (UoM, or MU) quantifies the doubt around a reported quantitative result. ISO 15189:2022 requires clinical labs to estimate MU for measured quantities, review it periodically, and make it available on request. It is expressed as a standard or expanded uncertainty (usually at 95% confidence, k=2).

The top-down approach

Clinical labs typically use the practical top-down method: combine the long-term imprecision from internal quality control (uRw, the CV of your IQC over time) with the uncertainty of the bias estimate (ubias, from EQA/peer data). The combined standard uncertainty is uc = √(uRw² + ubias²), and the expanded uncertainty U = k × uc with k=2.

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Frequently asked questions

How do clinical labs calculate UoM?

Most use the top-down approach: combine internal QC imprecision (CV) with the uncertainty of bias, then expand with k=2 for ~95% confidence. QCnomics does this per analyte from your own QC data.

Is UoM mandatory for ISO 15189:2022?

Yes, for measured quantitative results labs must estimate measurement uncertainty, review it, and provide it to users on request.

Do I need a spreadsheet for UoM?

No. QCnomics derives UoM automatically from accumulated IQC and EQA data and keeps it updated.

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