Measurement of uncertainty
Expanded uncertainty calculator
Calculate and report measurement uncertainty in compliance with ISO 15189:2022, GUM:2008, and JCGM 100 guidelines for accredited clinical laboratories.
Gum:2008 compliant
Iso 15189:2022 ready
Pdf report export
CV × 1.96 calculator
Imprecision-based uncertainty at 95% CI
CV% × 1.96 is a simplified way of estimating uncertainty from random error (imprecision) only at approximately 95% confidence.
Formula: U = 1.96 × CV%
Example: If CV% = 2.0%, then U = 1.96 × 2.0 = 3.92%
This means results vary by approximately ±3.92% around the true value at 95% confidence.
Note: This estimates imprecision-based expanded uncertainty only. Full ISO 15189:2022 MU also incorporates bias: k × √(CV² + Bias²)
Formula: U = 1.96 × CV%
Example: If CV% = 2.0%, then U = 1.96 × 2.0 = 3.92%
This means results vary by approximately ±3.92% around the true value at 95% confidence.
Note: This estimates imprecision-based expanded uncertainty only. Full ISO 15189:2022 MU also incorporates bias: k × √(CV² + Bias²)
unit
⚠ Mean value is required
unit
⚠ Standard deviation is required
obs
⚠ Number of replicates must be ≥ 1
🔬
Results will appear here
Enter your mean value and CV%, then click Calculate U = 1.96 × CV% to see imprecision-based expanded uncertainty.
—
Replicates (n)
—
CV (%)
1.96
Z-Score
≈ 95%
Confidence
Uncertainty Results
U = 1.96 × CV%
—
CV (imprecision)
SD / x̄ × 100
—
% coefficient of variation
Z-score applied
z = 1.96
1.96
95% confidence (normal dist.)
Expanded U%
1.96 × CV%
—
Relative expanded uncertainty
Absolute ±U
(U%/100) × x̄
—
Same units as mean value
✓
—
—
Calculation history
Saved locally in browser
0 records
📋
No history yet
Perform a calculation and click "Save to History" to store results here. Data is saved in your browser's local storage.
Interpretation guide
Based on relative expanded uncertainty (%U)
✓
Low Uncertainty — %U ≤ 5%
Measurement uncertainty is within acceptable limits. Results can be reported with high confidence. Routine QC monitoring is sufficient. Suitable for all clinical decision thresholds.
⚠
Moderate Uncertainty — 5% < %U ≤ 10%
Acceptable in most routine clinical contexts. Consider reviewing imprecision and bias sources. Monitor trends in QC data. Results near clinical decision limits should be interpreted with caution.
✕
High Uncertainty — %U > 10%
Uncertainty exceeds typical laboratory quality goals. Investigate root causes — check calibration, reagent lot stability, analyst technique, and instrument performance. Results require clinical context. Consider corrective action before reporting.
ISO 15189:2022 key clauses
Relevant MU requirements
| Clause | Requirement |
|---|---|
| 7.3.3 | Laboratory shall determine MU for each examination |
| 7.3.3 b) | MU shall be estimated with k=2 unless otherwise justified |
| 7.3.3 c) | MU shall be evaluated at medically relevant concentrations |
| 7.3.3 d) | MU shall be reviewed if analytical performance changes |
| 7.4.1.2 | MU shall be reported on request; available to users |
CV% Calculator
Enter individual values — SD and Mean calculated automatically
Formula
CV% = (SD ÷ Mean) × 100
Add at least 2 values. Minimum recommended: 20 values for stable SD.
Standard deviation
—
Mean value
—
⚠ Please add at least 2 values to calculate CV%
CV%
—
—
Unit converter
Common clinical laboratory units
→
—
Levey-Jennings chart
QC trend visualization
📈
Levey-Jennings integration
Plot QC data over time with mean ±1SD, ±2SD, and ±3SD control limits. Identify systematic and random errors visually from your QC run history.
Plot QC data
Westgard rules engine
Multi-rule QC violation checker
⚖️
Westgard multi-rules
Automated evaluation of 1₂ₛ, 1₃ₛ, 2₂ₛ, R₄ₛ, 4₁ₛ, and 10ₓ rules across single and multiple control materials. Warning and rejection rule logic integrated.
Analyze now
ISO 15189 Laboratory Report
Measurement Uncertainty — Formal Report Document
Clinical Laboratory — Uncertainty Report
ISO 15189:2022 · Gum:2008 compliant
Doc No: MU-—
Issued: —
1. Examination Details
Analyte / Test
—
Mean value (x̄)
—
Coverage Factor (k)
—
Std Deviation (SD)
—
Replicates (n)
—
Bias (%)
—
2. Calculated Uncertainty Components
CV%
—
Imprecision
Z-Score
1.96
95% confidence
U% = 1.96 × CV
—
Expanded uncertainty
Absolute ±U
—
Same units as mean
3. Calculation Trace
4. Interpretation & Conclusion
5. Authorization
Laboratory Scientist / Analyst
Laboratory Manager / Authorizing Signatory
