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Measurement Uncertainty: Practical Lab Guide (ISO 15189 • GUM • CLSI)

Learn how to calculate and report measurement uncertainty (uncertainty of measurement) for clinical and analytical labs — step-by-step, practical examples, and the exact formulas used in ISO 15189 and CLSI guidance. This video covers precision (internal QC), bias (EQAS/Bio-Rad), pooled vs level SD, how to combine components into a complete uncertainty budget, and how to report expanded uncertainty (k=2).

What you’ll get in this video
• Simple explanation of what measurement uncertainty means for lab results.
• How to calculate the precision component (single-level SD and pooled SD).
• How to calculate the bias component using EQAS / Bio-Rad data (Option A vs Option B).
• Exact formulas you can copy to Excel and real numeric examples.
• When to use pooled SD vs nearest-level SD, and practical accreditation tips (ISO 15189).
• How to build a complete uncertainty budget and report results clinicians understand.

Why this matters
Accurate uncertainty reporting improves clinical interpretation, helps you meet laboratory accreditation requirements (ISO 15189 / ISO 17025), and defends your results in audits and clinical decisions.

Key terms covered: measurement uncertainty, uncertainty of measurement, analytical uncertainty, uncertainty budget, precision and accuracy, bias and EQAS, internal QC, ISO 15189, GUM, CLSI, uncertainty evaluation.

Quick action steps:

Gather 4–6 EQAS rounds + internal QC data.

Calculate SD (single level) or pooled SD for precision.

Compute bias per EQAS round; choose Option A (no correction) or Option B (apply correction) based on stability and investigation.

Combine components by RSS → get combined standard uncertainty
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Expand with
k=2 and report: Result ± U (k=2).
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